November 21, 2024 • 57 mins
“Our mission is to make cancer less deadly through widely accessible next-generation early-detection blood tests.” Susan Tousi, CEO of Delfi Diagnostics, tells Bloomberg Intelligence in this episode of the Vanguards of Health Care podcast. Tousi joins BI analyst Jonathan Palmer to discuss the company’s fragment-based liquid biopsy technology and the immense opportunity to save lives through early cancer detection. Starting with lung cancer via its FirstLook test, Delfi expects to expand more broadly into other cancer types and applications like monitoring with a focus on access and affordability. The conversation touches on the company’s core values and the large opportunity set afforded by recent funding rounds.
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Speaker 1 (00:22):
Welcome to another episode of the Vanguards of Healthcare podcast,
where we chat with the leaders at the forefront of
change in the healthcare industry. My name is Jonathan Palmer
and I'm a healthcare analyst at Bloomberg Intelligence, the in
house research arm of Bloomberg. We're very happy to welcome
Susan Tuccy to our latest episode. She's the CEO of
Delphi Diagnostics. Before she was appointed to head Delphi at
(00:44):
the start of the year, she spent over a decade
at the sequencing powerhouse Alumina, starting and engineering, progressing into
product and culminating in the chief commercial Officer role. Earlier
in her career, she spent time at Hewett, Packard and
e Spenkodac and R and D and leadership roles. Welcome
to the podcast season.
Speaker 2 (01:04):
Thank you so much, Jonathan.
Speaker 1 (01:05):
Well, why don't we start off with, like, what's the
problem that DELFA is trying to solve in the ecosystem
and why does it exist?
Speaker 2 (01:12):
Yeah? Thank you for asking that. Our mission is to
make cancer less deadly through widely accessible next generation early
detection blood tests, which is a mouthful, but basically finding
cancer early is you know, game changing. It's when patients
have options, when cancer can be curable, when at least
(01:36):
the level of risk to one's life is lower. So
it's all about you know, very high sensitivity, early detection.
But doing that at a cost structure and an availability
that is kind of population scale requires new thinking and
new technology. So I mean we call ourselves next generation
(01:59):
and doing it in a simple blood test, one blood
draw that can happen, you know, while you're still at
the doctor's office, doesn't require another appointment to go in
and you know and get a scan done or something
that's more invasive. And so we believe that by providing
this simple blood test that we are going to be
(02:21):
able to save many more lives. And would love to
talk about lung cancer, which.
Speaker 1 (02:26):
Sure, yeah, let's dive into it. Yeah, so your first
products there, correct.
Speaker 2 (02:30):
Yes, So our first product is first Look Lung and
it is addressing the wide gap in lung cancer screening
and Lung Cancer Awareness Month. But I feel that most
people don't realize that lung cancer is the deadliest cancer killer.
One out of five cancer deaths is lung cancer. It
(02:51):
takes more lives in the US than correctal cancer, breast cancer,
and cervical cancer combined. And yet this reading test for
lung cancer, which is low dose CT scanning, is just
not taken. It's less than six percent of people who
are eligible for screening this after ten years that it's
(03:13):
been in guidelines, less than six percent actually yet screened.
So ninety four percent of the eligible population are not
getting screened. As a result, lung cancer is the deadliest
cancer killer. Sixty two percent of lung cancers are found
late stage. And it's such a tragedy because when found early,
(03:34):
the prognosis can be very good. Is there seventy three
percent survival rate a ten year survival rate when lung
cancer is detected.
Speaker 1 (03:42):
Early cent in stage one or stage two?
Speaker 2 (03:44):
Yes, exactly. And so we have really, you know, focused
our technology and our blood test, our simple blood test
on finding early stage stage one lung cancer. And so
we've really focused on high sensitivity early stage and also
making it accessible. And so I mentioned that, you know,
(04:07):
although low dos CT scanning has been in guidelines, the
access to a scan isn't always there. You have to
take a day off work, you have to schedule an appointment,
the results can come back late. There's false positives for
all these reasons. You know, the rate of adoption is
very low, and this is unlike screening for breast cancer
(04:30):
or kronoscopy or so forth, which is more in the
sixty to eighty percent. This is less than six percent,
and in some regions of our country, in California, it's
zero point seven percent.
Speaker 1 (04:41):
Really, essentially, yes, what are the demographics of the typical
patient who presents with lung cancers? Because I know, I
think most of us probably naturally assume it's a smoker.
But that's not the case, is it.
Speaker 2 (04:52):
Yeah, well, I mean, our test is really focused on
the eligible population today, which has a smoking history. So
these are people fifty to eighty years old who smoked
twenty pack years, so packa day for twenty years, and
have quit within the last kind of fifteen years. So
that is the population that's eligible today. But we know
(05:16):
that there is a population of never smokers who also
get lung cancer. In fact, you know, some studies are
that that population is increasing. So we are excited about
looking at potentially extending our extended intended use. But even
you know before that we have fifteen million people in
(05:36):
the US who are eligible who are not getting screened.
So it's an immediate problem that we can address, and
hopefully you know, we can. We have studies ongoing and
partnerships to look at the population beyond the intended use,
and some of that could be due to environmental exposure
or genetic markers that.
Speaker 1 (05:57):
Are more susceptible.
Speaker 2 (05:58):
Yes, we believe the immediate problem of those you know
who had have a smoking history, who are in the
eligible population is is something that a simple blood test,
especially you mentioned the demographics, I mean, the screening rates
are worse than the most underserved populations, and so we
(06:22):
believe that you know, a blood test means that you know,
this screen can be done anywhere. You can get a
simple blood draw. You don't have to be your fancy
cancer center with the best imaging technology. I mean, you
can really provide annual screening to the most underserved, to
(06:43):
you know, the kind of the most remote populations. And
that's our you know, that's our vision kind of long term.
Speaker 1 (06:49):
Well, maybe let's dive into the test a little bit
in the underlying technology. I mean, I think you and
I both know a lot about liquid biopsy, but just
for maybe some of our listeners who aren't as familiar
with the technology, and how it's used. Can maybe just
give us a layman's overview of liquid biopsy and how
that the test actually works.
Speaker 2 (07:07):
Yeah, so liquid biopsy is based on the fact that
there are clues in the blood stream that a person
might have cancer. And when you know, this is kind
of based on the fact that when a cancer cell
is dying and it sheds its DNA into the blood stream,
the fragments that come from that cancer cell are different
(07:31):
from a healthy cell that dies and sheds its DNA
into the bloodstream. So looking at those fragments and looking
for telltale characteristics and these can be based on genetic markers,
epigenetic markers, and from the chromatin kind of packing within
the cell itself. And so our technology is, you know,
(07:51):
the kind of next version of this. I mean, previously,
the approach that was taken was looking at just certain
features in that self free DNA we call it self
free DNA that comes from cancer cells, and those certain
features might not be in every fragment and so these
are mutations that you know, typically are associated with the cancer.
(08:12):
And so the sensitivity was very difficult and very expensive
because you had to do very deep, you know, exotic
kind of sequencing to get to these markers. This approach
was founded by doctor Victor vel Keleski out of Johns Hopkins,
and you know, twenty nineteen kind of spun out the
technology to become this company, and it was based on
rather than looking at just certain points on these and
(08:35):
the self free DNA, look at the entire genome of
these self free features. Now that you know, the cost
of sequencing has come down and like we have access
I was, I was part of the team that helped
to make that happen. But looking at the entire genome
of these fragments, you have millions of features and data
(08:58):
points and with the advance of algorithm them some machine
learning and AI, we can drive a very high signal
to noise and get high sensitivity at early stage cancer.
Speaker 1 (09:10):
So maybe how does the approach without getting two in
the weeds on the science, but how does it differ
than some of the other liquid biopsy companies. And we've
had a couple founders on here who started before twenty nineteen,
So maybe at a very high level, you know, how
does Delfi's technology differ. And I guess maybe as a
core or an answerary question to that, you know, what
is your freedom to operate in patent protection around what
(09:33):
you're doing.
Speaker 2 (09:35):
Yeah, So our approach is based on fragment tomics, and
it is you know, the previous generations of technology. We're
looking at mutation sites that are looking at panels that
were looking at kind of a needle in a haystack,
looking at these mutations, doing deep sequencing sometimes you know,
(09:56):
several assays to kind of get to a signal for cancer.
Because we look at the entire genome wide of these fragments,
we do low pass whole genome sequencing, so we get
tremendous amount more data. Instead of a needle in a haystack,
we're looking at the whole haystack and we as a result,
(10:18):
you know, we can make this test very low cost
and so we we do one blood draw, look at
the entire genome, and the heavy lifting is done in
the machine learning and AI out. So because we've trained
on so many of these kind of cancer specific features
(10:39):
over the course of now even before the company was founded,
we have you know, tremendous sophistication in these algorithms for
finding cancer. So that's how it's different. And because this
whole genome, I mean there's so much more that we
can do, so we keep improving, you know, based on
the fact that there's so much data to be to
(11:00):
be learned from. And so you asked about freedom to operate, Well,
we were the founders of this approach of fragment to
makes in fact, the majority of patents in this area.
We have more than kind of fifty patents either a
shoot or in process. So we really do have the
kind of franchise on like fragment tomeks based technology and patents.
(11:22):
It's our novel technology that's great.
Speaker 1 (11:25):
And so if we rewind back to twenty nineteen, you know,
when the company was founded, what were some of the
clinical milestones that the company had to hit to kind
of prove out the concept that that first look would
actually work and be commercially viable.
Speaker 2 (11:38):
It's a really good point because I think for these
tests to take off, there has to be evidence, and
we believe, you know, strongly in making our evidence kind
of publicly available and real world. So the first milestones,
our first paper was published in Nature in twenty nineteen
(11:58):
and it showed frag andtomics used to in a multi
cancer setting for the seven deadliest cancer Since then, we
just had a systematic kind of like publication, you know,
that has really allowed our approach to be kind of
vetted by the community. And you know, I would point
(12:19):
out some of the more foundational ones are Cancer Discovery
paper on our l one oh one trial. This was
our case control trial. This showed the performance of our
test for lung cancer across all lung cancers. It shows
you know, our sensitivity at stage one, our overall sensitivity.
And that publication was earlier this year, and we have continued.
(12:45):
We have publications fairly recently in liver cancer, in ovarian cancer,
and even you know, recently, very recently we published in
Nature Communications for our monitoring application. Okay, and this is
using the same underlying technology from monitoring response to treatment,
(13:07):
and you know, all based on fragmatics.
Speaker 1 (13:10):
So maybe the question that I have is and I
think I know the answer here by what you've already said,
But it sounds like the one cancer test is a
the beachhead and there's more to come, I guess. You know,
I know you weren't with the company at the time,
but do you know what was the what was the
kind of crucial decision that said let's go to one
cancer of those seven cancers that were done in that
initial paper. Was it the commercial opportunity or or the
(13:32):
sensitivity or specificity you know what maybe drove that decision.
Speaker 2 (13:36):
Yeah, well, lung cancer is is one of the more
difficult cancers from kind of getting high sensitivity and because
there were you know, a number of approaches for colorectal already.
I mean, lung cancer, as I mentioned, is just it's
a huge societal problem. It's a tragedy that you know,
this is cancer that can be treated, that can have prognosis,
(14:00):
and and yet it's so underserved. So I think there
was a feeling I mean kind of based on the
mission of the company, based on the technology can get
us there with other technologies might not, And and I
think it was you know, it really was an opportunity
to make the biggest impact and difference, and of course
then that serves to have also the biggest kind of
(14:21):
commercial opportunity as well. But I think it started with really,
you know, our mission is to make cancer less deadly,
and here's this, you know, cancer that has this huge
gaping problem and so long we were the first liquid
biopsy for lung cancer as a result, and we're we're
really you know, excited to be working with a number
(14:44):
of partners who are now adopting the test and helping
us to generate evidence of its impact.
Speaker 1 (14:48):
Well, that's a great segue, So let's talk about maybe
the commercialization of the test. You know, how does that
how does that look like, what does that roadmap look like?
Speaker 2 (14:56):
Yeah, so I'll start with some of the clinical trials
that we have going because that's really important that we
are committed to get getting to get to reimbursement. And
so we have three seminal trials. One is a European
trial it's going to read out in the first half
of next year. It's called four in the Long Run
for It tail R. We have a US trial it's
(15:19):
our Cascade Trials twelve thousand participants. Our European trials nine thousand,
and our US trial kind of really focused on the FDA,
reads out in twenty twenty six. And then we have
a real world trial. Because we have a product on
the market, we can do kind of a real world
study of randomized by practice practices that offer our tests
(15:40):
showing like higher screening rates, and we expect that to
be published in kind of late next year or twenty
twenty six. So all of these are generating the evidence
for reimbursement for approval, which is the US Preventive Services
Task Force and then the FDA. In the meantime, we
have you know, some really important partners we call them
(16:04):
early experienced partners who've adopted the test and happy to.
Speaker 1 (16:08):
Talk about that. That'd be great, Yeah, please, let's go
into it.
Speaker 2 (16:11):
So one that you know was one of our first
partners was ordered St. Francis OSF and they are an
integrated hospital system sixteen hospitals in Illinois and Michigan, and
they are offering our test in their primary care setting
to show that they can improve screening rates by offering
(16:33):
a blood based test. And so they've you know, they're
kind of been trained, we're integrated in their system and
and you know, generating evidence that they have it at
eighteen sites today and after a year kind of based
on looking at the screening rates, they intend to kind
of to expand it to all of their all of
(16:56):
their franchise. We have a partnership with City of Hope.
I mentioned, you know, in California, screening rates point seven percent.
City of Hope is one of the largest research and
treatment you know, cancer facilities in the US and the world,
and we're partnering with them to provide the test as
(17:17):
part of a clinical study to some of the most
underserved communities in Los Angeles County. And so this is
a study. For participants in this study, the test is
free of charge, and you know, we'll be studying kind
of the impact on what is a very low sub
kind of one percent screening rate.
Speaker 1 (17:36):
Wow, that's great.
Speaker 2 (17:37):
Yeah. And another one is Allegany Health Network. This is
in Pennsylvania, and we are providing the test, working with
hn Algay Health Networks physicians to do a study over
the course of two years to show the improvement screening
by providing the test at primary care and palmonology practices.
(18:00):
And so all of these are kind of leading up
to kind of generating the body of evidence and also
kind of offering the test immediately and not you know,
waiting for handfull reimbursement. So we're really excited about these partnerships.
I just we launched the one with Florida Lung Health
Coalition and rad NEET and American Lung Association, which will
(18:25):
provide the test in kind of central Florida and expand
from there. So we're really excited about that partnership. And
if I can mention one last one would be with
the Indigenous Pack which they're you know, kind of leaders
in providing kind of healthcare and healthcare access to the
Indigenous community. And so this one was actually called out
(18:47):
by the Biden Cancer Moonshot and their fact sheet, which
you know is we're really partnering with them to provide
the test in a way that is kind of respectful
to the cultural norm of the tribal communities, starting with
tribes in the Pacific Northwest and then expanding from there
and also with a with an eye tours inclusivity and access.
(19:10):
So we're very excited about the results.
Speaker 1 (19:12):
Those are all great. You know, if we think about
the business model and reimbursement being down down the road,
you know, what is that going to look like? From
I don't know an ASP perspective. You know, how are
you are? You are you charging people for the test today?
I think it probably depends on the partnership or the study.
But if I were I don't know, if I were
the demographic that wanted to go get screened and I
(19:33):
wanted to pay at a pocket could.
Speaker 2 (19:34):
I well, I mean today, where we're offering the test,
it is essentially being paid for. There are some cases
where there's you know, there's some out of pocket expense
for participants, but it's really nominal our test. I mean,
first of all, you know, kind of we intend to
always have the lowest cost structure and be able to
(19:56):
provide the test at the lowest cost because we feel
at first screening to get to a population scale, it
can't be in the thousands of dollars, it has to
be in the hundreds of dollars. So we're committed to
that aim and our core technology was kind of focused
on that aim. And so with the first partnerships that
(20:17):
I mentioned, they're being paid for entirely through grant money
or through the organization itself. With AHN, it's h N
and high Mark, they have kind of a payer that
is you know, kind of connected with their health delivery,
and so they're paying for the test and doing this
as part of the study at OSF, they're paying for
(20:39):
the test all of it to look at the impact
on kind of screening rates, and we show actually we
have economic models that show by paying for the test,
because the test is very affordable by paying for the test,
the institution can actually make three to one in return. Really, yes,
the economics are great. We intend to keep the economics
(21:02):
such that they are achievable, you know, by by systems
and of course, you know, ultimately getting to kind of
full reimbursement.
Speaker 1 (21:10):
If I think out to the future, it sounds like
it's going to be a mix of specialists and primary care.
Is that the right way to think about it? Yes?
Is there a preference there?
Speaker 2 (21:20):
Yeah, I you know, I think that the preference would
be where screening can happen right everywhere, everywhere, And I
think that the focus on primary care is just that
there's you know, well one, there's a lot more primary
primary care practices. Two that you know, this should be
(21:40):
part of your routine blood work. So you know, if
you're in for your routine blood work and you are
flagged to be part of this at risk population in
the HR, then you know, your physician offers the test
and you get the blood drop before you leave the
premises as part of any other blood work that you're
getting done, So that will be the test that gets done,
(22:02):
and of course we want it to be offered also
in the kind of pulmonary care where patients may be
seeing a specialist.
Speaker 1 (22:10):
Or if they're presenting with something, or if.
Speaker 2 (22:12):
They're presenting with something, or if the you know, their
specialist is particularly concerned. And in some cases they might
have gotten a low dose CT scan, but they maybe
aren't doing it annually. It's just tests that should happen annually,
and so maybe this is something that just gets people
like just on track to do it annually. And the
(22:34):
way it works is, you know, we have a binary result.
You're either elevated or you're not elevated. If you if
your test comes back not elevating, get it back within
a couple of weeks, so you're not waiting months for
like you know, someone to read a scan. Get it
back within a couple of weeks. If you're not elevated,
nine to nine point eight percent chance that you don't
have lung cancer. You just come back next year and
(22:54):
you get your blood drawn. If it's elevated, you are
more than five times likely than the rest of the
at risk population to actually find lung cancer in your scan.
You should be very motivated to get a scan, and
then the number needed to scan is less than half
to kind of actually find a cancer. So that's how
kind of the economics also work out the combination of
(23:17):
our elevated result and the scan provides a much more
effective kind of approach to you know, where you're more
likely to find lung cancer and a better kind of
risk scenario for those who actually get a scan.
Speaker 1 (23:32):
No, that all makes sense. I mean it sounds like
the NPV of the test must be very very very high. Yes,
And thinking about that, was that the sensitivity or the
NPV that's the NCP? I'm sorry, sensitivity.
Speaker 2 (23:45):
Yeah, the sensitivity is eighty percent and sensitivity at stage
one is you know, kind of seventy three percent stage one.
Speaker 1 (23:53):
So got it? Okay, I think I can work out
all the math. Fine. Hey, you know, if we think
about the mandate of a news CEO coming into the organization,
I mean it was a founder who at organization to start.
You know, what, what were you told by the board
to do or maybe do differently. I don't want to
say there was a wholesale change, but you're a very
seasoned executive, you know, with a lot of great experience
on your resume. You know, as you approached this new role,
(24:16):
what did you see had to happen over the first
I don't know, six months, twelve months to really I
guess reinforce that the board made the right decision.
Speaker 2 (24:26):
Yeah, I am so lucky to be taking over from
such an incredible founders. You know, Victor l. Kelescu, you
had already had a successful company PHPX that sold a
lab core and it's been you know, it's been a
pleasure working with them. I think there was an understanding that,
you know, Victor is not going to be the person
(24:46):
who takes this all the way to take a commercial
effort and you know, kind of scaling the company. So
my you know, my uh edict was to really focus
the company on what are we all about and you know,
what is our what what do we what's our mission?
What we are going to achieve, and then to actually
(25:09):
like make it available, like execute on making making that
mission uh achievable, making the product commercially available, having a
roadmap of what we're going to do next and doing
that all within you know, what we can afford, and
making a making a real company that can kind of
stand alone in you know, in the future. So I
(25:32):
it's been it's been absolute pleasure, and so I've been
hard at work on First of all, there's so much
we can do with this technology, and I think that's
one of the challenges about a small company is getting
super focused on what are we going to do. I
really see the opportunity for us to be the leaders
(25:52):
in early cancer detection, and so, you know, really focused
on that. And there's a lot of other things that
we can we'll get to them as time allows, but
we can't lose our focus on you know, on this
and and so you know, building the company starting with
building leadership team really kind of driving in the values
(26:15):
and that are really kind of surrounding this incredible mission
that we have. And our values, which are so core
are that you know, we lead with science, but we
anchor in pragmatism that we're building with and for all,
so that idea of access and that we put we
(26:36):
over I so we're doing this as a team. The
mission is bigger than any one of us or any
one person's agenda. And so those are the three kind
of core values that are foundational and everything we do.
Speaker 1 (26:47):
How big is the company today? Just thinking about that
that team.
Speaker 2 (26:51):
Yeah, we're one hundred and fifty people strong, and which
is you know, sizable for a small company. We have
two locations and one palle alt where we have our
cap clear lab and on patient samples, and then of
course being spun out of Johns Hopkins, we have a
location in Baltimore which is our research lab. And so
we're one hundred and fifty people and I be excited
(27:13):
to tell you about the new leaders that we've added.
Speaker 1 (27:15):
Feel free.
Speaker 2 (27:16):
Yeah, yeah, So you know, I've been hard at work
in building the kind of C suite of the company
to kind of take us to the next phase. And
I could not be more excited about the team that
we've assembled. We already had a very strong team, but
I think kind of you know, shaping it for the
next generation. And the leaders of the company have such
(27:39):
a kind of outsize impact on the values and the culture,
and so you know, choosing the right people has taken
me months, and I can't tell you how many people
I've interviewed and talked to, but I feel so confident
about our Of course, our chief medical officer who's already
part of the company, Peter Box.
Speaker 1 (28:00):
Yeah, Peter is pretty well known.
Speaker 2 (28:02):
He is a renowned worldwide expert in lung cancer guidelines.
He's written a lot of the guidelines in lung cancer screening.
So we're so fortunate to have him be part of
everything that we've done. I added a CFO, Tom Russo,
who comes from having had successful careers as a research
channalyst in pharma, giliad in other biotechs. He had a
(28:26):
successful exit at Ikosovacs, which sold to Astroseneca. I went
public and then sold to astro Seneca. So Tom has
been a phenomenal addition to the team. Just recently added
our chief Commercial Officer, who is Rob Geigley finally getting
his pronunciation at his name correctly. He comes most recently
(28:49):
as having been the chief commercial Officer at NBT and
before that at Ambry, and so he brings such a
clear perspective on how to really get a diagnostic kind
of into the market and adopted and doing something that's
transformative and innovation led. And and then you know, just
recently hired our chief Technical officer, and and you know
(29:13):
she comes to us from having been the chief scientific
officer at Grail's great yes so not yeah, well ya singh.
She is just phenomenal you know, background computational biology. She
really understands a biology but also of course, you know
the importance of the kind of algorithmic nature of what
(29:35):
we do and has developed diagnostics, you know, very innovation minded,
phenomenal leader of people bringing out the best and kind
of teams of scientists and engineers. So yeah, I couldn't
couldn't ask for a stronger team. And and I would
say at the core, like all of us, you know
very much mission led want to see us make an impact.
Speaker 1 (29:57):
So one of the things you mentioned before was that
balance between I guess you know, I think if investment
dollars we're unlimited, you'd be doing everything at once. So
how do you balance that? I mean, the company's pretty
well funded. You've done I think two rounds a couple
hundred million dollars worth of funding according to crunch base.
But so who knows if those numbers are entirely accurate,
But you know, how do you sit from a cash
(30:19):
position today and kind of where are the core where
are the core pockets where you're maybe putting those dollars
to work.
Speaker 2 (30:26):
Yeah, we've raised and crunch base tells you that we've
raised more than three hundred and fifty million dollars. We
have like incredible syndicative investors, including two pharma partners, Lily
and Merk and we are well funded through early twenty
twenty six. Oh great, and so our next round would
be you know, sometime next year. We've been looking at
(30:49):
our Series C. We are putting our dollars to hard
work in our clinical trials, okay, and you know, thankfully
we've already invested and kind of our facilities, our Capcalia lab,
and you know, we can run patient samples kind of
up to summer and fifty thousand samples a year and
we're really well positioned from that standpoint. So it's really
(31:11):
kind of scaling our commercial efforts and you know, expanding
kind of access the commercial reach and continue to compile
the evidence and getting through our regulatory pathways. Those are
some of the kind of key areas.
Speaker 1 (31:25):
Where so how do you how do you do that?
Is it boots on the ground approach to to you know,
I hate to use the word detailing, having worked in
pharmaceuticals in the past, like that comes to mind.
Speaker 2 (31:37):
There's similarities in the environment sales. We you know, there
are a lot of companies that take in the approach
and you know, I've been commercial leaders, so I seen
the different models there are a lot of companies that
taken an approach that it is all about just like,
you know, kind of carpeting the the map of potential customers.
(31:59):
And I think we're, you know, we're at least starting
with a perspective of really partnering kind of at the
top of these healthcare systems and institutions that have a focus.
They already have kind of screening in mind, they haven't
focused on improving screening rates and working with the leaders
in these institutions, people who do population health, people really
(32:22):
care about this, and so it's a bit more tops down.
And I think that there's so many great tools now
available for integrating our test into EHRs, and we were
well into all of this, and I would say, had
we started, you know, ten years ago, we would had
to do all this ground up. We'd have to teach
people liquid biops even this, and you know, we're way
(32:44):
far down the road. Maybe it's good to be kind
of a fast follower in those ways.
Speaker 1 (32:47):
Yeah, it's interesting because you hear a lot of public
companies talk about EHR integrations, and I guess as a
person who sits outside the ecosystem, I'm always surprised I'm like,
this seems like it should be a very easy problem
to solve ordering tests for clinicians. There's only so many
tests any given you know, uh, treatment decision. It doesn't
(33:07):
seem like it should be that hard, but it apparently
is very hard.
Speaker 2 (33:10):
Well, I think it was harder if you were the
first at doing it. And I think now, you know,
as mentioned, I think this notion of getting new tests
into EHR, I think there's you know, great you know,
software connectors to kind of how we can easily integrate
into systems that are using kind of epic you know already.
So we're uh, you know, our approach is to you know,
(33:34):
not reinvent the wheel where it's already invented and people
have figured it out. We want to focus kind of
our i P and our our innovation around things that
we can really you know, change, And so I think
we're benefiting from a lot of that, which is making
I think the investment in some of the infrastructure lower.
(33:55):
And you know, I mentioned, you know, we already have
facilities that can run seven and fifty thousand samples because
we didn't you know, we leapfrogged into whole genome sequencing
and a much simpler assay. We're using kind of the
algorithms to do heavy lifting, whereas you know, those who
came before us, generation before us or two generations before us,
the essays are really complicated, the like you know, wet
(34:17):
lab and all the automation necessary, just the workflow different
assays steps are really difficult. And so you know, in
many ways, I think we've kind of had the benefit
of leap frogging and we intend to continue to do that.
Speaker 1 (34:29):
And so it's the right way to think about it.
That the the advantage it Well, so it sounds like
the assay is easier from a pure chemistry perspective, but
then is the back end on the technology side also
more sophisticated than previous generations as well.
Speaker 2 (34:45):
Yeah, I would say that the algorithms and the you know,
machine learning and AI that we have applied is where
you know a lot of the secret sauces. And if
you look at just you know, how we're invested in
terms of kind of our our d community, you'll see
a big kind of emphasis on that. Even the leader
that we're bringing for our chief technical officers going to
(35:07):
oversee all of our research and development activities, comes with
a computational biology and background, so that is you know,
it's a lot of the secret sauce.
Speaker 1 (35:18):
And so you know, with a company that has a
history and machine learning and AI just being all the rage,
you know, what is your thoughts around how transformational this
technology or and how quick we it's moving? How does
that impact what you guys are doing and maybe the
decisions from an investment perspective that you have to make today.
Speaker 2 (35:37):
Yeah, So, I mean we we believe in having the
core performance of the test, you know, to be like
leading edge as we offer it today and able to
solve a problem. But we're not done there. We have
a tenacious, relentless drive to continue to make it better.
(36:01):
And I think with you know the benefit of machine
learning and AI is it's always going to be improving
with access to more samples, the chronological trials that we're
running some really you know, amazing studies that we're participating
in with access to you know, thousands even hundreds of
thousands of samples, and with the commercial engagements or early
(36:25):
experienced partners that we have, our test like is getting
better every day, every month, every year. And so you know,
working with our our collaborators at the FDA, and you
are and really having in place and understanding that you know,
these tests not just ours, but I mean these tests
(36:47):
benefit from more data and every you know, a few months,
there's gonna be an opportunity to make them better. And
and so I I am a huge proponent of like
relentless innovation in this space. You know, we are just
at the beginning. I'm very proud of the performance that
we have that we're absolutely.
Speaker 1 (37:09):
Not stopping there.
Speaker 2 (37:10):
So so I think, yeah, so I think you know,
the machine learning and AI is going.
Speaker 1 (37:15):
To be how does that maybe work from a regulatory perspective?
You know, once you've got a test approved by let's
say f d A, and you go if you go
that route for example, and then which we are of
course everybody's going there. You'll get there, I'm sure. But
once you once you've shown them the data on I
don't know, version one point oh, you know, how do
(37:36):
you actually update them and to get them an approval
on two point oh? What are the mechanics behind that?
Speaker 2 (37:42):
Yeah? Well, I think kind of bridging to your next
version is a I mean, I think the FDA is
actually fairly practical in this you know, uh in this setting,
and you know, we we we really respect they're kind
of oversight of this. It's all based on evidence, and
you know, we we tend to always be showing kind
(38:03):
of the the evidence of how we can you know,
get better. And it's usually it's like they want to
see the clinical results and you know, the evidence that
underpins that. And so we're we've put in place kind
of a you know, the process for how we can
continue to evolve and you know, drive improvements in our test,
(38:27):
always with kind of clinical evidence backing, always with a
you know, validation. So we're you know, we're we're thinking,
we're thinking like that.
Speaker 1 (38:38):
That's great. Uh, maybe switching gears here, let's talk a
little bit about your background and your origin story. We're
both Penn State grads, although your degree is from the
engineering school, which I think is a little bit more
academically challenging than my my business school degree. Did you
always always aspire to be a CEO and a leader? I?
Speaker 2 (38:58):
Uh, I would say that my origin into engineering, I
never thought about being an engine I didn't know any
womenywhere engineers, I you know, never crossed my mind. I
knew I loved like science and math and you know.
But it wasn't until someone told me that engineers are
going to improve society, make lives better, invent things that
(39:22):
don't even exist today that are going to improve people's lives.
And that was like the that was the spark for
me that maybe even interested. I mean, before that, I
thought it was like, you know, your head isn't like
a engine, like you know, working by yourself making something
more powerful or fixing it or something like a.
Speaker 1 (39:39):
CAD program or some sort of drafting. Yeah, dating myself.
Speaker 2 (39:42):
Yeah, well, I I mean I think my first question
was like do I have to wear like overalls and
like that. But it wasn't until someone really in it
was a math teacher, like you know, made that spark
go off that you knows, wow, because I you know,
I come from a long line of medical doctors. My
father was a medical doctor, and I knew I didn't
want to spend all my time in a hospital and
(40:03):
like the side of blood and like people in pain
was like too traumatic for me. But I approaching it
from the aspect of technology was like really exciting, and
so you know, I yeh was motivated to go into engineering,
had a great opportunity. Pence Data studied Engineering science, which
(40:26):
was the honors discipline. I had a full ride.
Speaker 1 (40:29):
It was like great graduation.
Speaker 2 (40:31):
I went from like not thinking about engineering to you know,
graduating top of my class, mostly because it was like
so interesting and engineering science was was before like there
was the biomedical kind of degrees engineering science. The premise
was that to be a good engineer you had to
understand all disciplines of engineering, and you had to have
(40:52):
a lot of chemistry, and you need to understand the sciences,
and and we even had like nuclear engineering. We had
like every you know, every field of engineer, electrical, chemical, engineering,
so forth. And I absolutely I mean it just really
kind of sparked a passion in me that I didn't
even know existed. And so that.
Speaker 1 (41:13):
Was my Well so when the opportunity to go to
a lumina came up, did it did maybe some of
that thinking around medicine and healthcare come back to you
from your your family background, because I think of genomics
as a far more and maybe this is right or wrong,
but more into interdisciplinary approach to engineering than maybe some
(41:35):
other more focused areas, Like at what you were doing
at q A. Packard, I could be entirely wrong.
Speaker 2 (41:40):
Though yeah, I would say so. I mean after spending
you know, a couple of decades in high tech, which
was really exciting and moved fast and really brought out
kind of innovation we you know, created I think, amazing
innovative products. I had the opportunity. I really took a
step back and said, what do I want to do
(42:01):
next to my career? And it was always in my
heart to be able to take everything that was like
innovation and technology and progress into the space of healthcare.
What I always feared was like healthcare moved so slowly
in terms of innovation. You went into a hospital and
like all the equipment looked like it was from you know,
(42:24):
decades past, and so it looks like that it's getting better,
it's getting better. So it wasn't until I was turned
on to what was going on in genomics where the
cutting edge of like science and technology was being applied
to you know, shining light on biology in a way
that we never understood before. And so you know, being
(42:48):
being turned on to like the revolution that was going
to happen in genomics. And this was in twenty twelve,
so it hadn't happened just yet. But it was like
you know, the human genoman's been sequenced. It cost one
hundred thousand dollars, was a sequence at Genome at that time.
But like there was this idea that could get to
so affordable to be part of every medical test. And
(43:09):
you know, I think that the most compelling thing to
me was that, you know, my father was a doctor.
He practiced until he was well into his eighties. My father, Yeah,
it was amazing, and and he went into medicine because
you know, he lost his mom during a really complicated childbirth.
Speaker 1 (43:32):
I'm so sorry.
Speaker 2 (43:33):
Yeah, So that that really, you know, kind of put
him down the path of wanting to make a difference
in healthcare. And and and then he you know, focused
on women's health. He became an O B G Y N.
He did, you know, primarily at the end, in addition
to uh to delivering babies, he was primarily looking at
(43:54):
O wearing cancer patients, cervical cancer patients. And he was
really motivated making lives better for people. Never financially motivated,
I guess, toybody, but he served clinically motivated, very clinically motivated,
operated until like he couldn't do anymore. And so when
I told him that the technology I was working on
(44:16):
would lead to a non invasive test for understanding of
baby's health, non invasive prenatal testing by a simple blood draw.
My dad was like, he was amazed. He was so
proud that I was part of this. And he had
always been you know, he had always been concerned about
amusanth thesis as a risk to the mother and the
(44:38):
unborn child, and so he was so cautious about diagnostics
that were invasive like that. So the idea of that
IPT was like, oh my gosh, like wow, this is amazing,
This is amazing that the company you're working at is
like doing this, and so that, yeah, coming to genomics
was like closing the circle for me.
Speaker 1 (44:58):
What's so interesting when I think of liquid biopsy, I
see a lot of parallels to NIPT and I think
of sequinome launching and Veronata and all the other ones
that came out and it took a long time to
get into guidelines. And do you think it'll happen quicker
this time with liquid biopsy, just because there's maybe that
predecessor case sample of how to do this.
Speaker 2 (45:21):
Yeah, I think so. I think that you know, the
idea of molecular diagnostics has come a long way, but
like now decades into it, and what we see in
our regulatory partners in the FDA is that they're motivated
to want to help us to do this in a
way that's safe and effective for patients. So there's there's
(45:42):
a realization and this is true of all the healthcare systems.
The partners that we're working with. They have heard about
liquid biopsy. They are motivated by the potential that the
technology has, but everyone is cautious about like they want
to see the evidence. They want to see real world evidence,
(46:02):
which is you know, a responsibility for the industry to
to make sure that we're generating evidence. And and the
end point to us isn't just that you found cancer.
The endpoint has to be that it's saving lives. And
so you know, early detection having you know, what do
you do after it's detected in our case, while you're
getting an l DCT, it can lead to a surgery
(46:24):
or to kind of targeted kind of care. And so
we're we're motivated to make sure that this can drop
into a clinical pathway that's actually going to save lives.
And so that I think with that approach in mind,
that the healthcare industry I think is absolutely ready for
this and we're and we're seeing that.
Speaker 1 (46:45):
And do you have to do a lot of heavy
lifting on your side to maybe breach that monitoring MRD marketplace.
Speaker 2 (46:54):
Yeah, in terms of you know, that is a kind
of potential technoloage.
Speaker 1 (46:58):
If you want to go down that path in the future.
Is it a head uft either financially or scientifically.
Speaker 2 (47:04):
Yeah. So, I you know, as I mentioned, you know,
as a smallish company, we're focused on early detection, but
then we have this like incredible like potential of our
technology and in monitoring, and we have a research use
only version that we have made available to pharma companies.
(47:26):
We have a growing list of top pharma companies and
biotech companies who are using our It's the Delphi TF
for tumor fragment and this is to be able to
uh see the response to therapy. And this is for
late stage cancer typically stage three or four. But it
(47:47):
really serves them in their research work and kind of
pre you know, clinical trial work to be able to
see if a treatment is going to be effective or not.
And because it's low cost, it's too or naive, it's
you know, a very small amount of blood very low input.
It's it's gaining like massive traction. We are inspired to
(48:11):
kind of continue to work on the limited detection to
get to an MRD. And it's just you know, we're
we have an embarrassment of riches of what we can
do with the core technology, but we are we have
a number of approaches, including partnerships, which we may do
that soon.
Speaker 1 (48:27):
You know, we were talking before about building your team,
and I guess that was maybe the first step for
year one. You know, now that you've got the team assembled,
how's it going to change in year two? What's your
focus going to be?
Speaker 2 (48:38):
Yeah, well, I you know, the first year has been
all about understanding the company, meeting all the people, like
what is core to us, you know, putting our strategy
in place, and hiring people, hiring the leaders. As you mentioned,
I think now that I have people who are more
expert than I am leading each of the functions gives
me an opportunity to kind of put my head up
(49:00):
a little bit more and really think about being a
little bit more external, really think about what are the
biggest problems to solve in early cancer detection E actually
and monitoring and mr D that that our technology and
our capability is just uniquely positioned to do and I
(49:22):
I want to spend more time with that obviously, spend
more time with our partners and really look at how
we can scale faster, both through the partnerships we already
have with health systems, with our you know kind of
regulatory bodies, how we can make sure that we're on
track for those things, and and of course with our
growing kind of investor base and you know, those who
(49:45):
are committed believers who are funding.
Speaker 1 (49:49):
Of our per liquidity event at some point.
Speaker 2 (49:52):
Yeah, yeah, I mean we see a responsibility to get
and get ourselves to a position where we can get
to profitability. And you know that we can fund ourselves
and that you know that may lead to and naturally
to an IPO depending on market conditions, it could lead
to sting private and being profitable and well managed. We
(50:14):
have to kind of allow for all possibilities.
Speaker 1 (50:17):
Well, he said something that made my analyst brain twitch.
And that's the getting to profitability. But if you just
think about the key levers to that, what are that?
Where are the big where the big wins there?
Speaker 2 (50:26):
Yeah? Well, I mean we're serving such a big market
opportunity and lung alone, that we can get to profitability just.
Speaker 1 (50:35):
Through lung cancer, just on volumes.
Speaker 2 (50:38):
Just through volumes and penetrating lung can less than you know,
ten percent penetration of the lung cancer opportunity in the
US alone, And this is a global opportunity. And I
should mention that, I mean our test, the fact that
it is such an easy assay and the heavy lifting
is in the algorithms. We're already talking with partners internationally
(50:58):
about tech transferring into labs Capcalia kind of like labs
around the world to be able to run our tests
in location. And so that is another kind of expansion
possibility for us. But to your question of like we
can get to profitability just serving the lung cancer market
with you know, a modest penetration, but of course we're
(51:21):
not satisfied with just that, and and we are you know,
we have intent to be able to launch other cancer
tests into the market, and we're also working on just
making sure that the core technology and our ability to
understand tissue of origin, all those things can lead us
(51:42):
to even multi cancer application. We're very practically minded on
what is going to make the biggest impact. So whatever
we do in terms of kind of our next test
is going to be based on, you know, what is
the market opportunity, what is the clinical you know, utility
that this can drive and uh and of course you know,
(52:04):
how are we going to fund it?
Speaker 1 (52:05):
And there's that sweet spot there where you hit all
three and that then diagram.
Speaker 2 (52:09):
Absolutely, and we feel with lung cancer we're there and
we're and we're going to have fallen.
Speaker 1 (52:13):
How long you know, not to put you on the spot,
but how long would it take to do another another cancer?
Is is it a multi year process or some of
that works I'm sure is probably already underway.
Speaker 2 (52:25):
Yeah, as I mentioned, I mean we've had publications already
on liver cancer and recently on ovarying cancer. So we
think the evidence base of you know, the test actually
performing well and another cancer is there, it would be
you know a matter of you know, actually launching an
l d T and then kind of going down the
path that we have. We think that you know, another
(52:47):
l d T could be as you know, as soon
as in a year. Oh wow, that quick, Yes, And
we're gonna we're going to paste that based on kind
of what are the most pressing opportunities for invest that
we have at the time. But I mentioned also that
we you know, we have studies going on internationally, there
could be cancer indications that would be better launched initially
(53:12):
internationally and then you know, kind of following the following
the kind of regulatory practices kind of in that country.
There are so many underserved cancers abroad. To mention, you know,
lung cancer abroad is a huge problem. Other served there's
so many countries that haven't even adopted scanning, so this
(53:36):
would be a leap frog for them. But there are
other cancers, like liver cancer in some countries in you know, Asia,
for instance, liver cancer is not just the deadliest cancer killer,
it's the deadliest killer above heart disease or anything else.
So we just see, I mean, like the opportunity to
make a difference is kind of boundless, especially when you
(53:58):
have a test that's low cast lost and uh one
that you know can be kind of transferred to the
you know, and the kind of easy way that ours is.
Speaker 1 (54:06):
Well, it's a great story, yeah, and thank you so
much for sharing it. The way I like to wrap
up these conversations that we touched on this probably a
little bit already is what drives the guests. You know,
what lessons have they learned in their life that they
like to apply to their day to day or share
with their teams. And so I think I know where
you're going to go with your answer, but I would
ask you that same question as well.
Speaker 2 (54:27):
Yeah, well, I'm a big believer in you know, the
kind of mission of a company. I guess, you know,
Simon Sinak, and like the why you know as like
the most important thing. I mean, there's what you do
and how you do it, Like the why why are
we here? What is the problem that we're solving? Is
the opportunity that we're addressing. I am so passionate about
(54:49):
making a difference in cancer. I mean, whose lives you
know have not been impacted by cancer? One? Cancer diagnosis
impacts not just that individual, but like everyone around them, society,
and you know, being able to you know, stop that
in its tracks at the earliest stage is like the
only way we're going to get there. And so I
(55:11):
think that lessons that I've learned are about when you
have something that's so important that can be so compelling
to a group of people, that we can bring together
a group of like incredibly capable motivated, dedicated people, which
I feel we have at Delphi like that like protecting
that and cultivating that and feeding that like that is
(55:33):
I'm absolutely passionate about that, and I think making that sustainable,
like making sure that like we never lose sight of
like the impact that we can make and firing that passion.
I think I mentioned that, you know, relentless drive and
making our tests better and having like tests that are
(55:55):
meeting the most unmet need like pursuit of progress in
this and I think that that is motivated by kind
of mission and values and culture more so than you
can ever do financially. I mean that will come to
like the mission I think is something that like the
sense of purpose that you give individuals is so overwhelmingly powerful.
(56:17):
So that's what I've learned. And so I mentioned like
building leadership of the team of the company that can
really you know, fire those passions and bring out the
best in our people to to you know, kind of
power that and drive progress. I think we're like just
(56:38):
like a relentless drive to have progress and make a difference.
Speaker 1 (56:42):
That was wonderful. I can tell your passion is very
very evident. Thank you so much for joining us. Today,
and I hope you'll come back in a couple of
years and tell us how our things are going.
Speaker 2 (56:50):
Thank you, Jonathan, it's been absolute pleasure.
Speaker 1 (56:53):
That's Susan two, c CEO of Delphi Diagnostics. Thank you
so much for joining us today for our latest episode.
Then please make sure to click the follow button on
your favorite podcast app so you never miss a discussion
with the leaders in healthcare innovation. I'm Jonathan Palmer, and
you've been listening to the Vanguards of Healthcare podcast by
Bloomberg Intelligence. Until next time, take care,
Welcome to another episode of the Vanguards of Healthcare podcast,
where we chat with the leaders at the forefront of
change in the healthcare industry. My name is Jonathan Palmer
and I'm a healthcare analyst at Bloomberg Intelligence, the in
house research arm of Bloomberg. We're very happy to welcome
Susan Tuccy to our latest episode. She's the CEO of
Delphi Diagnostics. Before she was appointed to head Delphi at
(00:44):
the start of the year, she spent over a decade
at the sequencing powerhouse Alumina, starting and engineering, progressing into
product and culminating in the chief commercial Officer role. Earlier
in her career, she spent time at Hewett, Packard and
e Spenkodac and R and D and leadership roles. Welcome
to the podcast season.
Speaker 2 (01:04):
Thank you so much, Jonathan.
Speaker 1 (01:05):
Well, why don't we start off with, like, what's the
problem that DELFA is trying to solve in the ecosystem
and why does it exist?
Speaker 2 (01:12):
Yeah? Thank you for asking that. Our mission is to
make cancer less deadly through widely accessible next generation early
detection blood tests, which is a mouthful, but basically finding
cancer early is you know, game changing. It's when patients
have options, when cancer can be curable, when at least
(01:36):
the level of risk to one's life is lower. So
it's all about you know, very high sensitivity, early detection.
But doing that at a cost structure and an availability
that is kind of population scale requires new thinking and
new technology. So I mean we call ourselves next generation
(01:59):
and doing it in a simple blood test, one blood
draw that can happen, you know, while you're still at
the doctor's office, doesn't require another appointment to go in
and you know and get a scan done or something
that's more invasive. And so we believe that by providing
this simple blood test that we are going to be
(02:21):
able to save many more lives. And would love to
talk about lung cancer, which.
Speaker 1 (02:26):
Sure, yeah, let's dive into it. Yeah, so your first
products there, correct.
Speaker 2 (02:30):
Yes, So our first product is first Look Lung and
it is addressing the wide gap in lung cancer screening
and Lung Cancer Awareness Month. But I feel that most
people don't realize that lung cancer is the deadliest cancer killer.
One out of five cancer deaths is lung cancer. It
(02:51):
takes more lives in the US than correctal cancer, breast cancer,
and cervical cancer combined. And yet this reading test for
lung cancer, which is low dose CT scanning, is just
not taken. It's less than six percent of people who
are eligible for screening this after ten years that it's
(03:13):
been in guidelines, less than six percent actually yet screened.
So ninety four percent of the eligible population are not
getting screened. As a result, lung cancer is the deadliest
cancer killer. Sixty two percent of lung cancers are found
late stage. And it's such a tragedy because when found early,
(03:34):
the prognosis can be very good. Is there seventy three
percent survival rate a ten year survival rate when lung
cancer is detected.
Speaker 1 (03:42):
Early cent in stage one or stage two?
Speaker 2 (03:44):
Yes, exactly. And so we have really, you know, focused
our technology and our blood test, our simple blood test
on finding early stage stage one lung cancer. And so
we've really focused on high sensitivity early stage and also
making it accessible. And so I mentioned that, you know,
(04:07):
although low dos CT scanning has been in guidelines, the
access to a scan isn't always there. You have to
take a day off work, you have to schedule an appointment,
the results can come back late. There's false positives for
all these reasons. You know, the rate of adoption is
very low, and this is unlike screening for breast cancer
(04:30):
or kronoscopy or so forth, which is more in the
sixty to eighty percent. This is less than six percent,
and in some regions of our country, in California, it's
zero point seven percent.
Speaker 1 (04:41):
Really, essentially, yes, what are the demographics of the typical
patient who presents with lung cancers? Because I know, I
think most of us probably naturally assume it's a smoker.
But that's not the case, is it.
Speaker 2 (04:52):
Yeah, well, I mean, our test is really focused on
the eligible population today, which has a smoking history. So
these are people fifty to eighty years old who smoked
twenty pack years, so packa day for twenty years, and
have quit within the last kind of fifteen years. So
that is the population that's eligible today. But we know
(05:16):
that there is a population of never smokers who also
get lung cancer. In fact, you know, some studies are
that that population is increasing. So we are excited about
looking at potentially extending our extended intended use. But even
you know before that we have fifteen million people in
(05:36):
the US who are eligible who are not getting screened.
So it's an immediate problem that we can address, and
hopefully you know, we can. We have studies ongoing and
partnerships to look at the population beyond the intended use,
and some of that could be due to environmental exposure
or genetic markers that.
Speaker 1 (05:57):
Are more susceptible.
Speaker 2 (05:58):
Yes, we believe the immediate problem of those you know
who had have a smoking history, who are in the
eligible population is is something that a simple blood test,
especially you mentioned the demographics, I mean, the screening rates
are worse than the most underserved populations, and so we
(06:22):
believe that you know, a blood test means that you know,
this screen can be done anywhere. You can get a
simple blood draw. You don't have to be your fancy
cancer center with the best imaging technology. I mean, you
can really provide annual screening to the most underserved, to
(06:43):
you know, the kind of the most remote populations. And
that's our you know, that's our vision kind of long term.
Speaker 1 (06:49):
Well, maybe let's dive into the test a little bit
in the underlying technology. I mean, I think you and
I both know a lot about liquid biopsy, but just
for maybe some of our listeners who aren't as familiar
with the technology, and how it's used. Can maybe just
give us a layman's overview of liquid biopsy and how
that the test actually works.
Speaker 2 (07:07):
Yeah, so liquid biopsy is based on the fact that
there are clues in the blood stream that a person
might have cancer. And when you know, this is kind
of based on the fact that when a cancer cell
is dying and it sheds its DNA into the blood stream,
the fragments that come from that cancer cell are different
(07:31):
from a healthy cell that dies and sheds its DNA
into the bloodstream. So looking at those fragments and looking
for telltale characteristics and these can be based on genetic markers,
epigenetic markers, and from the chromatin kind of packing within
the cell itself. And so our technology is, you know,
(07:51):
the kind of next version of this. I mean, previously,
the approach that was taken was looking at just certain
features in that self free DNA we call it self
free DNA that comes from cancer cells, and those certain
features might not be in every fragment and so these
are mutations that you know, typically are associated with the cancer.
(08:12):
And so the sensitivity was very difficult and very expensive
because you had to do very deep, you know, exotic
kind of sequencing to get to these markers. This approach
was founded by doctor Victor vel Keleski out of Johns Hopkins,
and you know, twenty nineteen kind of spun out the
technology to become this company, and it was based on
rather than looking at just certain points on these and
(08:35):
the self free DNA, look at the entire genome of
these self free features. Now that you know, the cost
of sequencing has come down and like we have access
I was, I was part of the team that helped
to make that happen. But looking at the entire genome
of these fragments, you have millions of features and data
(08:58):
points and with the advance of algorithm them some machine
learning and AI, we can drive a very high signal
to noise and get high sensitivity at early stage cancer.
Speaker 1 (09:10):
So maybe how does the approach without getting two in
the weeds on the science, but how does it differ
than some of the other liquid biopsy companies. And we've
had a couple founders on here who started before twenty nineteen,
So maybe at a very high level, you know, how
does Delfi's technology differ. And I guess maybe as a
core or an answerary question to that, you know, what
is your freedom to operate in patent protection around what
(09:33):
you're doing.
Speaker 2 (09:35):
Yeah, So our approach is based on fragment tomics, and
it is you know, the previous generations of technology. We're
looking at mutation sites that are looking at panels that
were looking at kind of a needle in a haystack,
looking at these mutations, doing deep sequencing sometimes you know,
(09:56):
several assays to kind of get to a signal for cancer.
Because we look at the entire genome wide of these fragments,
we do low pass whole genome sequencing, so we get
tremendous amount more data. Instead of a needle in a haystack,
we're looking at the whole haystack and we as a result,
(10:18):
you know, we can make this test very low cost
and so we we do one blood draw, look at
the entire genome, and the heavy lifting is done in
the machine learning and AI out. So because we've trained
on so many of these kind of cancer specific features
(10:39):
over the course of now even before the company was founded,
we have you know, tremendous sophistication in these algorithms for
finding cancer. So that's how it's different. And because this
whole genome, I mean there's so much more that we
can do, so we keep improving, you know, based on
the fact that there's so much data to be to
(11:00):
be learned from. And so you asked about freedom to operate, Well,
we were the founders of this approach of fragment to
makes in fact, the majority of patents in this area.
We have more than kind of fifty patents either a
shoot or in process. So we really do have the
kind of franchise on like fragment tomeks based technology and patents.
(11:22):
It's our novel technology that's great.
Speaker 1 (11:25):
And so if we rewind back to twenty nineteen, you know,
when the company was founded, what were some of the
clinical milestones that the company had to hit to kind
of prove out the concept that that first look would
actually work and be commercially viable.
Speaker 2 (11:38):
It's a really good point because I think for these
tests to take off, there has to be evidence, and
we believe, you know, strongly in making our evidence kind
of publicly available and real world. So the first milestones,
our first paper was published in Nature in twenty nineteen
(11:58):
and it showed frag andtomics used to in a multi
cancer setting for the seven deadliest cancer Since then, we
just had a systematic kind of like publication, you know,
that has really allowed our approach to be kind of
vetted by the community. And you know, I would point
(12:19):
out some of the more foundational ones are Cancer Discovery
paper on our l one oh one trial. This was
our case control trial. This showed the performance of our
test for lung cancer across all lung cancers. It shows
you know, our sensitivity at stage one, our overall sensitivity.
And that publication was earlier this year, and we have continued.
(12:45):
We have publications fairly recently in liver cancer, in ovarian cancer,
and even you know, recently, very recently we published in
Nature Communications for our monitoring application. Okay, and this is
using the same underlying technology from monitoring response to treatment,
(13:07):
and you know, all based on fragmatics.
Speaker 1 (13:10):
So maybe the question that I have is and I
think I know the answer here by what you've already said,
But it sounds like the one cancer test is a
the beachhead and there's more to come, I guess. You know,
I know you weren't with the company at the time,
but do you know what was the what was the
kind of crucial decision that said let's go to one
cancer of those seven cancers that were done in that
initial paper. Was it the commercial opportunity or or the
(13:32):
sensitivity or specificity you know what maybe drove that decision.
Speaker 2 (13:36):
Yeah, well, lung cancer is is one of the more
difficult cancers from kind of getting high sensitivity and because
there were you know, a number of approaches for colorectal already.
I mean, lung cancer, as I mentioned, is just it's
a huge societal problem. It's a tragedy that you know,
this is cancer that can be treated, that can have prognosis,
(14:00):
and and yet it's so underserved. So I think there
was a feeling I mean kind of based on the
mission of the company, based on the technology can get
us there with other technologies might not, And and I
think it was you know, it really was an opportunity
to make the biggest impact and difference, and of course
then that serves to have also the biggest kind of
(14:21):
commercial opportunity as well. But I think it started with really,
you know, our mission is to make cancer less deadly,
and here's this, you know, cancer that has this huge
gaping problem and so long we were the first liquid
biopsy for lung cancer as a result, and we're we're
really you know, excited to be working with a number
(14:44):
of partners who are now adopting the test and helping
us to generate evidence of its impact.
Speaker 1 (14:48):
Well, that's a great segue, So let's talk about maybe
the commercialization of the test. You know, how does that
how does that look like, what does that roadmap look like?
Speaker 2 (14:56):
Yeah, so I'll start with some of the clinical trials
that we have going because that's really important that we
are committed to get getting to get to reimbursement. And
so we have three seminal trials. One is a European
trial it's going to read out in the first half
of next year. It's called four in the Long Run
for It tail R. We have a US trial it's
(15:19):
our Cascade Trials twelve thousand participants. Our European trials nine thousand,
and our US trial kind of really focused on the FDA,
reads out in twenty twenty six. And then we have
a real world trial. Because we have a product on
the market, we can do kind of a real world
study of randomized by practice practices that offer our tests
(15:40):
showing like higher screening rates, and we expect that to
be published in kind of late next year or twenty
twenty six. So all of these are generating the evidence
for reimbursement for approval, which is the US Preventive Services
Task Force and then the FDA. In the meantime, we
have you know, some really important partners we call them
(16:04):
early experienced partners who've adopted the test and happy to.
Speaker 1 (16:08):
Talk about that. That'd be great, Yeah, please, let's go
into it.
Speaker 2 (16:11):
So one that you know was one of our first
partners was ordered St. Francis OSF and they are an
integrated hospital system sixteen hospitals in Illinois and Michigan, and
they are offering our test in their primary care setting
to show that they can improve screening rates by offering
(16:33):
a blood based test. And so they've you know, they're
kind of been trained, we're integrated in their system and
and you know, generating evidence that they have it at
eighteen sites today and after a year kind of based
on looking at the screening rates, they intend to kind
of to expand it to all of their all of
(16:56):
their franchise. We have a partnership with City of Hope.
I mentioned, you know, in California, screening rates point seven percent.
City of Hope is one of the largest research and
treatment you know, cancer facilities in the US and the world,
and we're partnering with them to provide the test as
(17:17):
part of a clinical study to some of the most
underserved communities in Los Angeles County. And so this is
a study. For participants in this study, the test is
free of charge, and you know, we'll be studying kind
of the impact on what is a very low sub
kind of one percent screening rate.
Speaker 1 (17:36):
Wow, that's great.
Speaker 2 (17:37):
Yeah. And another one is Allegany Health Network. This is
in Pennsylvania, and we are providing the test, working with
hn Algay Health Networks physicians to do a study over
the course of two years to show the improvement screening
by providing the test at primary care and palmonology practices.
(18:00):
And so all of these are kind of leading up
to kind of generating the body of evidence and also
kind of offering the test immediately and not you know,
waiting for handfull reimbursement. So we're really excited about these partnerships.
I just we launched the one with Florida Lung Health
Coalition and rad NEET and American Lung Association, which will
(18:25):
provide the test in kind of central Florida and expand
from there. So we're really excited about that partnership. And
if I can mention one last one would be with
the Indigenous Pack which they're you know, kind of leaders
in providing kind of healthcare and healthcare access to the
Indigenous community. And so this one was actually called out
(18:47):
by the Biden Cancer Moonshot and their fact sheet, which
you know is we're really partnering with them to provide
the test in a way that is kind of respectful
to the cultural norm of the tribal communities, starting with
tribes in the Pacific Northwest and then expanding from there
and also with a with an eye tours inclusivity and access.
(19:10):
So we're very excited about the results.
Speaker 1 (19:12):
Those are all great. You know, if we think about
the business model and reimbursement being down down the road,
you know, what is that going to look like? From
I don't know an ASP perspective. You know, how are
you are? You are you charging people for the test today?
I think it probably depends on the partnership or the study.
But if I were I don't know, if I were
the demographic that wanted to go get screened and I
(19:33):
wanted to pay at a pocket could.
Speaker 2 (19:34):
I well, I mean today, where we're offering the test,
it is essentially being paid for. There are some cases
where there's you know, there's some out of pocket expense
for participants, but it's really nominal our test. I mean,
first of all, you know, kind of we intend to
always have the lowest cost structure and be able to
(19:56):
provide the test at the lowest cost because we feel
at first screening to get to a population scale, it
can't be in the thousands of dollars, it has to
be in the hundreds of dollars. So we're committed to
that aim and our core technology was kind of focused
on that aim. And so with the first partnerships that
(20:17):
I mentioned, they're being paid for entirely through grant money
or through the organization itself. With AHN, it's h N
and high Mark, they have kind of a payer that
is you know, kind of connected with their health delivery,
and so they're paying for the test and doing this
as part of the study at OSF, they're paying for
(20:39):
the test all of it to look at the impact
on kind of screening rates, and we show actually we
have economic models that show by paying for the test,
because the test is very affordable by paying for the test,
the institution can actually make three to one in return. Really, yes,
the economics are great. We intend to keep the economics
(21:02):
such that they are achievable, you know, by by systems
and of course, you know, ultimately getting to kind of
full reimbursement.
Speaker 1 (21:10):
If I think out to the future, it sounds like
it's going to be a mix of specialists and primary care.
Is that the right way to think about it? Yes?
Is there a preference there?
Speaker 2 (21:20):
Yeah, I you know, I think that the preference would
be where screening can happen right everywhere, everywhere, And I
think that the focus on primary care is just that
there's you know, well one, there's a lot more primary
primary care practices. Two that you know, this should be
(21:40):
part of your routine blood work. So you know, if
you're in for your routine blood work and you are
flagged to be part of this at risk population in
the HR, then you know, your physician offers the test
and you get the blood drop before you leave the
premises as part of any other blood work that you're
getting done, So that will be the test that gets done,
(22:02):
and of course we want it to be offered also
in the kind of pulmonary care where patients may be
seeing a specialist.
Speaker 1 (22:10):
Or if they're presenting with something, or if.
Speaker 2 (22:12):
They're presenting with something, or if the you know, their
specialist is particularly concerned. And in some cases they might
have gotten a low dose CT scan, but they maybe
aren't doing it annually. It's just tests that should happen annually,
and so maybe this is something that just gets people
like just on track to do it annually. And the
(22:34):
way it works is, you know, we have a binary result.
You're either elevated or you're not elevated. If you if
your test comes back not elevating, get it back within
a couple of weeks, so you're not waiting months for
like you know, someone to read a scan. Get it
back within a couple of weeks. If you're not elevated,
nine to nine point eight percent chance that you don't
have lung cancer. You just come back next year and
(22:54):
you get your blood drawn. If it's elevated, you are
more than five times likely than the rest of the
at risk population to actually find lung cancer in your scan.
You should be very motivated to get a scan, and
then the number needed to scan is less than half
to kind of actually find a cancer. So that's how
kind of the economics also work out the combination of
(23:17):
our elevated result and the scan provides a much more
effective kind of approach to you know, where you're more
likely to find lung cancer and a better kind of
risk scenario for those who actually get a scan.
Speaker 1 (23:32):
No, that all makes sense. I mean it sounds like
the NPV of the test must be very very very high. Yes,
And thinking about that, was that the sensitivity or the
NPV that's the NCP? I'm sorry, sensitivity.
Speaker 2 (23:45):
Yeah, the sensitivity is eighty percent and sensitivity at stage
one is you know, kind of seventy three percent stage one.
Speaker 1 (23:53):
So got it? Okay, I think I can work out
all the math. Fine. Hey, you know, if we think
about the mandate of a news CEO coming into the organization,
I mean it was a founder who at organization to start.
You know, what, what were you told by the board
to do or maybe do differently. I don't want to
say there was a wholesale change, but you're a very
seasoned executive, you know, with a lot of great experience
on your resume. You know, as you approached this new role,
(24:16):
what did you see had to happen over the first
I don't know, six months, twelve months to really I
guess reinforce that the board made the right decision.
Speaker 2 (24:26):
Yeah, I am so lucky to be taking over from
such an incredible founders. You know, Victor l. Kelescu, you
had already had a successful company PHPX that sold a
lab core and it's been you know, it's been a
pleasure working with them. I think there was an understanding that,
you know, Victor is not going to be the person
(24:46):
who takes this all the way to take a commercial
effort and you know, kind of scaling the company. So
my you know, my uh edict was to really focus
the company on what are we all about and you know,
what is our what what do we what's our mission?
What we are going to achieve, and then to actually
(25:09):
like make it available, like execute on making making that
mission uh achievable, making the product commercially available, having a
roadmap of what we're going to do next and doing
that all within you know, what we can afford, and
making a making a real company that can kind of
stand alone in you know, in the future. So I
(25:32):
it's been it's been absolute pleasure, and so I've been
hard at work on First of all, there's so much
we can do with this technology, and I think that's
one of the challenges about a small company is getting
super focused on what are we going to do. I
really see the opportunity for us to be the leaders
(25:52):
in early cancer detection, and so, you know, really focused
on that. And there's a lot of other things that
we can we'll get to them as time allows, but
we can't lose our focus on you know, on this
and and so you know, building the company starting with
building leadership team really kind of driving in the values
(26:15):
and that are really kind of surrounding this incredible mission
that we have. And our values, which are so core
are that you know, we lead with science, but we
anchor in pragmatism that we're building with and for all,
so that idea of access and that we put we
(26:36):
over I so we're doing this as a team. The
mission is bigger than any one of us or any
one person's agenda. And so those are the three kind
of core values that are foundational and everything we do.
Speaker 1 (26:47):
How big is the company today? Just thinking about that
that team.
Speaker 2 (26:51):
Yeah, we're one hundred and fifty people strong, and which
is you know, sizable for a small company. We have
two locations and one palle alt where we have our
cap clear lab and on patient samples, and then of
course being spun out of Johns Hopkins, we have a
location in Baltimore which is our research lab. And so
we're one hundred and fifty people and I be excited
(27:13):
to tell you about the new leaders that we've added.
Speaker 1 (27:15):
Feel free.
Speaker 2 (27:16):
Yeah, yeah, So you know, I've been hard at work
in building the kind of C suite of the company
to kind of take us to the next phase. And
I could not be more excited about the team that
we've assembled. We already had a very strong team, but
I think kind of you know, shaping it for the
next generation. And the leaders of the company have such
(27:39):
a kind of outsize impact on the values and the culture,
and so you know, choosing the right people has taken
me months, and I can't tell you how many people
I've interviewed and talked to, but I feel so confident
about our Of course, our chief medical officer who's already
part of the company, Peter Box.
Speaker 1 (28:00):
Yeah, Peter is pretty well known.
Speaker 2 (28:02):
He is a renowned worldwide expert in lung cancer guidelines.
He's written a lot of the guidelines in lung cancer screening.
So we're so fortunate to have him be part of
everything that we've done. I added a CFO, Tom Russo,
who comes from having had successful careers as a research
channalyst in pharma, giliad in other biotechs. He had a
(28:26):
successful exit at Ikosovacs, which sold to Astroseneca. I went
public and then sold to astro Seneca. So Tom has
been a phenomenal addition to the team. Just recently added
our chief Commercial Officer, who is Rob Geigley finally getting
his pronunciation at his name correctly. He comes most recently
(28:49):
as having been the chief commercial Officer at NBT and
before that at Ambry, and so he brings such a
clear perspective on how to really get a diagnostic kind
of into the market and adopted and doing something that's
transformative and innovation led. And and then you know, just
recently hired our chief Technical officer, and and you know
(29:13):
she comes to us from having been the chief scientific
officer at Grail's great yes so not yeah, well ya singh.
She is just phenomenal you know, background computational biology. She
really understands a biology but also of course, you know
the importance of the kind of algorithmic nature of what
(29:35):
we do and has developed diagnostics, you know, very innovation minded,
phenomenal leader of people bringing out the best and kind
of teams of scientists and engineers. So yeah, I couldn't
couldn't ask for a stronger team. And and I would
say at the core, like all of us, you know
very much mission led want to see us make an impact.
Speaker 1 (29:57):
So one of the things you mentioned before was that
balance between I guess you know, I think if investment
dollars we're unlimited, you'd be doing everything at once. So
how do you balance that? I mean, the company's pretty
well funded. You've done I think two rounds a couple
hundred million dollars worth of funding according to crunch base.
But so who knows if those numbers are entirely accurate,
But you know, how do you sit from a cash
(30:19):
position today and kind of where are the core where
are the core pockets where you're maybe putting those dollars
to work.
Speaker 2 (30:26):
Yeah, we've raised and crunch base tells you that we've
raised more than three hundred and fifty million dollars. We
have like incredible syndicative investors, including two pharma partners, Lily
and Merk and we are well funded through early twenty
twenty six. Oh great, and so our next round would
be you know, sometime next year. We've been looking at
(30:49):
our Series C. We are putting our dollars to hard
work in our clinical trials, okay, and you know, thankfully
we've already invested and kind of our facilities, our Capcalia lab,
and you know, we can run patient samples kind of
up to summer and fifty thousand samples a year and
we're really well positioned from that standpoint. So it's really
(31:11):
kind of scaling our commercial efforts and you know, expanding
kind of access the commercial reach and continue to compile
the evidence and getting through our regulatory pathways. Those are
some of the kind of key areas.
Speaker 1 (31:25):
Where so how do you how do you do that?
Is it boots on the ground approach to to you know,
I hate to use the word detailing, having worked in
pharmaceuticals in the past, like that comes to mind.
Speaker 2 (31:37):
There's similarities in the environment sales. We you know, there
are a lot of companies that take in the approach
and you know, I've been commercial leaders, so I seen
the different models there are a lot of companies that
taken an approach that it is all about just like,
you know, kind of carpeting the the map of potential customers.
(31:59):
And I think we're, you know, we're at least starting
with a perspective of really partnering kind of at the
top of these healthcare systems and institutions that have a focus.
They already have kind of screening in mind, they haven't
focused on improving screening rates and working with the leaders
in these institutions, people who do population health, people really
(32:22):
care about this, and so it's a bit more tops down.
And I think that there's so many great tools now
available for integrating our test into EHRs, and we were
well into all of this, and I would say, had
we started, you know, ten years ago, we would had
to do all this ground up. We'd have to teach
people liquid biops even this, and you know, we're way
(32:44):
far down the road. Maybe it's good to be kind
of a fast follower in those ways.
Speaker 1 (32:47):
Yeah, it's interesting because you hear a lot of public
companies talk about EHR integrations, and I guess as a
person who sits outside the ecosystem, I'm always surprised I'm like,
this seems like it should be a very easy problem
to solve ordering tests for clinicians. There's only so many
tests any given you know, uh, treatment decision. It doesn't
(33:07):
seem like it should be that hard, but it apparently
is very hard.
Speaker 2 (33:10):
Well, I think it was harder if you were the
first at doing it. And I think now, you know,
as mentioned, I think this notion of getting new tests
into EHR, I think there's you know, great you know,
software connectors to kind of how we can easily integrate
into systems that are using kind of epic you know already.
So we're uh, you know, our approach is to you know,
(33:34):
not reinvent the wheel where it's already invented and people
have figured it out. We want to focus kind of
our i P and our our innovation around things that
we can really you know, change, And so I think
we're benefiting from a lot of that, which is making
I think the investment in some of the infrastructure lower.
(33:55):
And you know, I mentioned, you know, we already have
facilities that can run seven and fifty thousand samples because
we didn't you know, we leapfrogged into whole genome sequencing
and a much simpler assay. We're using kind of the
algorithms to do heavy lifting, whereas you know, those who
came before us, generation before us or two generations before us,
the essays are really complicated, the like you know, wet
(34:17):
lab and all the automation necessary, just the workflow different
assays steps are really difficult. And so you know, in
many ways, I think we've kind of had the benefit
of leap frogging and we intend to continue to do that.
Speaker 1 (34:29):
And so it's the right way to think about it.
That the the advantage it Well, so it sounds like
the assay is easier from a pure chemistry perspective, but
then is the back end on the technology side also
more sophisticated than previous generations as well.
Speaker 2 (34:45):
Yeah, I would say that the algorithms and the you know,
machine learning and AI that we have applied is where
you know a lot of the secret sauces. And if
you look at just you know, how we're invested in
terms of kind of our our d community, you'll see
a big kind of emphasis on that. Even the leader
that we're bringing for our chief technical officers going to
(35:07):
oversee all of our research and development activities, comes with
a computational biology and background, so that is you know,
it's a lot of the secret sauce.
Speaker 1 (35:18):
And so you know, with a company that has a
history and machine learning and AI just being all the rage,
you know, what is your thoughts around how transformational this
technology or and how quick we it's moving? How does
that impact what you guys are doing and maybe the
decisions from an investment perspective that you have to make today.
Speaker 2 (35:37):
Yeah, So, I mean we we believe in having the
core performance of the test, you know, to be like
leading edge as we offer it today and able to
solve a problem. But we're not done there. We have
a tenacious, relentless drive to continue to make it better.
(36:01):
And I think with you know the benefit of machine
learning and AI is it's always going to be improving
with access to more samples, the chronological trials that we're
running some really you know, amazing studies that we're participating
in with access to you know, thousands even hundreds of
thousands of samples, and with the commercial engagements or early
(36:25):
experienced partners that we have, our test like is getting
better every day, every month, every year. And so you know,
working with our our collaborators at the FDA, and you
are and really having in place and understanding that you know,
these tests not just ours, but I mean these tests
(36:47):
benefit from more data and every you know, a few months,
there's gonna be an opportunity to make them better. And
and so I I am a huge proponent of like
relentless innovation in this space. You know, we are just
at the beginning. I'm very proud of the performance that
we have that we're absolutely.
Speaker 1 (37:09):
Not stopping there.
Speaker 2 (37:10):
So so I think, yeah, so I think you know,
the machine learning and AI is going.
Speaker 1 (37:15):
To be how does that maybe work from a regulatory perspective?
You know, once you've got a test approved by let's
say f d A, and you go if you go
that route for example, and then which we are of
course everybody's going there. You'll get there, I'm sure. But
once you once you've shown them the data on I
don't know, version one point oh, you know, how do
(37:36):
you actually update them and to get them an approval
on two point oh? What are the mechanics behind that?
Speaker 2 (37:42):
Yeah? Well, I think kind of bridging to your next
version is a I mean, I think the FDA is
actually fairly practical in this you know, uh in this setting,
and you know, we we we really respect they're kind
of oversight of this. It's all based on evidence, and
you know, we we tend to always be showing kind
(38:03):
of the the evidence of how we can you know,
get better. And it's usually it's like they want to
see the clinical results and you know, the evidence that
underpins that. And so we're we've put in place kind
of a you know, the process for how we can
continue to evolve and you know, drive improvements in our test,
(38:27):
always with kind of clinical evidence backing, always with a
you know, validation. So we're you know, we're we're thinking,
we're thinking like that.
Speaker 1 (38:38):
That's great. Uh, maybe switching gears here, let's talk a
little bit about your background and your origin story. We're
both Penn State grads, although your degree is from the
engineering school, which I think is a little bit more
academically challenging than my my business school degree. Did you
always always aspire to be a CEO and a leader? I?
Speaker 2 (38:58):
Uh, I would say that my origin into engineering, I
never thought about being an engine I didn't know any
womenywhere engineers, I you know, never crossed my mind. I
knew I loved like science and math and you know.
But it wasn't until someone told me that engineers are
going to improve society, make lives better, invent things that
(39:22):
don't even exist today that are going to improve people's lives.
And that was like the that was the spark for
me that maybe even interested. I mean, before that, I
thought it was like, you know, your head isn't like
a engine, like you know, working by yourself making something
more powerful or fixing it or something like a.
Speaker 1 (39:39):
CAD program or some sort of drafting. Yeah, dating myself.
Speaker 2 (39:42):
Yeah, well, I I mean I think my first question
was like do I have to wear like overalls and
like that. But it wasn't until someone really in it
was a math teacher, like you know, made that spark
go off that you knows, wow, because I you know,
I come from a long line of medical doctors. My
father was a medical doctor, and I knew I didn't
want to spend all my time in a hospital and
(40:03):
like the side of blood and like people in pain
was like too traumatic for me. But I approaching it
from the aspect of technology was like really exciting, and
so you know, I yeh was motivated to go into engineering,
had a great opportunity. Pence Data studied Engineering science, which
(40:26):
was the honors discipline. I had a full ride.
Speaker 1 (40:29):
It was like great graduation.
Speaker 2 (40:31):
I went from like not thinking about engineering to you know,
graduating top of my class, mostly because it was like
so interesting and engineering science was was before like there
was the biomedical kind of degrees engineering science. The premise
was that to be a good engineer you had to
understand all disciplines of engineering, and you had to have
(40:52):
a lot of chemistry, and you need to understand the sciences,
and and we even had like nuclear engineering. We had
like every you know, every field of engineer, electrical, chemical, engineering,
so forth. And I absolutely I mean it just really
kind of sparked a passion in me that I didn't
even know existed. And so that.
Speaker 1 (41:13):
Was my Well so when the opportunity to go to
a lumina came up, did it did maybe some of
that thinking around medicine and healthcare come back to you
from your your family background, because I think of genomics
as a far more and maybe this is right or wrong,
but more into interdisciplinary approach to engineering than maybe some
(41:35):
other more focused areas, Like at what you were doing
at q A. Packard, I could be entirely wrong.
Speaker 2 (41:40):
Though yeah, I would say so. I mean after spending
you know, a couple of decades in high tech, which
was really exciting and moved fast and really brought out
kind of innovation we you know, created I think, amazing
innovative products. I had the opportunity. I really took a
step back and said, what do I want to do
(42:01):
next to my career? And it was always in my
heart to be able to take everything that was like
innovation and technology and progress into the space of healthcare.
What I always feared was like healthcare moved so slowly
in terms of innovation. You went into a hospital and
like all the equipment looked like it was from you know,
(42:24):
decades past, and so it looks like that it's getting better,
it's getting better. So it wasn't until I was turned
on to what was going on in genomics where the
cutting edge of like science and technology was being applied
to you know, shining light on biology in a way
that we never understood before. And so you know, being
(42:48):
being turned on to like the revolution that was going
to happen in genomics. And this was in twenty twelve,
so it hadn't happened just yet. But it was like
you know, the human genoman's been sequenced. It cost one
hundred thousand dollars, was a sequence at Genome at that time.
But like there was this idea that could get to
so affordable to be part of every medical test. And
(43:09):
you know, I think that the most compelling thing to
me was that, you know, my father was a doctor.
He practiced until he was well into his eighties. My father, Yeah,
it was amazing, and and he went into medicine because
you know, he lost his mom during a really complicated childbirth.
Speaker 1 (43:32):
I'm so sorry.
Speaker 2 (43:33):
Yeah, So that that really, you know, kind of put
him down the path of wanting to make a difference
in healthcare. And and and then he you know, focused
on women's health. He became an O B G Y N.
He did, you know, primarily at the end, in addition
to uh to delivering babies, he was primarily looking at
(43:54):
O wearing cancer patients, cervical cancer patients. And he was
really motivated making lives better for people. Never financially motivated,
I guess, toybody, but he served clinically motivated, very clinically motivated,
operated until like he couldn't do anymore. And so when
I told him that the technology I was working on
(44:16):
would lead to a non invasive test for understanding of
baby's health, non invasive prenatal testing by a simple blood draw.
My dad was like, he was amazed. He was so
proud that I was part of this. And he had
always been you know, he had always been concerned about
amusanth thesis as a risk to the mother and the
(44:38):
unborn child, and so he was so cautious about diagnostics
that were invasive like that. So the idea of that
IPT was like, oh my gosh, like wow, this is amazing,
This is amazing that the company you're working at is
like doing this, and so that, yeah, coming to genomics
was like closing the circle for me.
Speaker 1 (44:58):
What's so interesting when I think of liquid biopsy, I
see a lot of parallels to NIPT and I think
of sequinome launching and Veronata and all the other ones
that came out and it took a long time to
get into guidelines. And do you think it'll happen quicker
this time with liquid biopsy, just because there's maybe that
predecessor case sample of how to do this.
Speaker 2 (45:21):
Yeah, I think so. I think that you know, the
idea of molecular diagnostics has come a long way, but
like now decades into it, and what we see in
our regulatory partners in the FDA is that they're motivated
to want to help us to do this in a
way that's safe and effective for patients. So there's there's
(45:42):
a realization and this is true of all the healthcare systems.
The partners that we're working with. They have heard about
liquid biopsy. They are motivated by the potential that the
technology has, but everyone is cautious about like they want
to see the evidence. They want to see real world evidence,
(46:02):
which is you know, a responsibility for the industry to
to make sure that we're generating evidence. And and the
end point to us isn't just that you found cancer.
The endpoint has to be that it's saving lives. And
so you know, early detection having you know, what do
you do after it's detected in our case, while you're
getting an l DCT, it can lead to a surgery
(46:24):
or to kind of targeted kind of care. And so
we're we're motivated to make sure that this can drop
into a clinical pathway that's actually going to save lives.
And so that I think with that approach in mind,
that the healthcare industry I think is absolutely ready for
this and we're and we're seeing that.
Speaker 1 (46:45):
And do you have to do a lot of heavy
lifting on your side to maybe breach that monitoring MRD marketplace.
Speaker 2 (46:54):
Yeah, in terms of you know, that is a kind
of potential technoloage.
Speaker 1 (46:58):
If you want to go down that path in the future.
Is it a head uft either financially or scientifically.
Speaker 2 (47:04):
Yeah. So, I you know, as I mentioned, you know,
as a smallish company, we're focused on early detection, but
then we have this like incredible like potential of our
technology and in monitoring, and we have a research use
only version that we have made available to pharma companies.
(47:26):
We have a growing list of top pharma companies and
biotech companies who are using our It's the Delphi TF
for tumor fragment and this is to be able to
uh see the response to therapy. And this is for
late stage cancer typically stage three or four. But it
(47:47):
really serves them in their research work and kind of
pre you know, clinical trial work to be able to
see if a treatment is going to be effective or not.
And because it's low cost, it's too or naive, it's
you know, a very small amount of blood very low input.
It's it's gaining like massive traction. We are inspired to
(48:11):
kind of continue to work on the limited detection to
get to an MRD. And it's just you know, we're
we have an embarrassment of riches of what we can
do with the core technology, but we are we have
a number of approaches, including partnerships, which we may do
that soon.
Speaker 1 (48:27):
You know, we were talking before about building your team,
and I guess that was maybe the first step for
year one. You know, now that you've got the team assembled,
how's it going to change in year two? What's your
focus going to be?
Speaker 2 (48:38):
Yeah, well, I you know, the first year has been
all about understanding the company, meeting all the people, like
what is core to us, you know, putting our strategy
in place, and hiring people, hiring the leaders. As you mentioned,
I think now that I have people who are more
expert than I am leading each of the functions gives
me an opportunity to kind of put my head up
(49:00):
a little bit more and really think about being a
little bit more external, really think about what are the
biggest problems to solve in early cancer detection E actually
and monitoring and mr D that that our technology and
our capability is just uniquely positioned to do and I
(49:22):
I want to spend more time with that obviously, spend
more time with our partners and really look at how
we can scale faster, both through the partnerships we already
have with health systems, with our you know kind of
regulatory bodies, how we can make sure that we're on
track for those things, and and of course with our
growing kind of investor base and you know, those who
(49:45):
are committed believers who are funding.
Speaker 1 (49:49):
Of our per liquidity event at some point.
Speaker 2 (49:52):
Yeah, yeah, I mean we see a responsibility to get
and get ourselves to a position where we can get
to profitability. And you know that we can fund ourselves
and that you know that may lead to and naturally
to an IPO depending on market conditions, it could lead
to sting private and being profitable and well managed. We
(50:14):
have to kind of allow for all possibilities.
Speaker 1 (50:17):
Well, he said something that made my analyst brain twitch.
And that's the getting to profitability. But if you just
think about the key levers to that, what are that?
Where are the big where the big wins there?
Speaker 2 (50:26):
Yeah? Well, I mean we're serving such a big market
opportunity and lung alone, that we can get to profitability just.
Speaker 1 (50:35):
Through lung cancer, just on volumes.
Speaker 2 (50:38):
Just through volumes and penetrating lung can less than you know,
ten percent penetration of the lung cancer opportunity in the
US alone, And this is a global opportunity. And I
should mention that, I mean our test, the fact that
it is such an easy assay and the heavy lifting
is in the algorithms. We're already talking with partners internationally
(50:58):
about tech transferring into labs Capcalia kind of like labs
around the world to be able to run our tests
in location. And so that is another kind of expansion
possibility for us. But to your question of like we
can get to profitability just serving the lung cancer market
with you know, a modest penetration, but of course we're
(51:21):
not satisfied with just that, and and we are you know,
we have intent to be able to launch other cancer
tests into the market, and we're also working on just
making sure that the core technology and our ability to
understand tissue of origin, all those things can lead us
(51:42):
to even multi cancer application. We're very practically minded on
what is going to make the biggest impact. So whatever
we do in terms of kind of our next test
is going to be based on, you know, what is
the market opportunity, what is the clinical you know, utility
that this can drive and uh and of course you know,
(52:04):
how are we going to fund it?
Speaker 1 (52:05):
And there's that sweet spot there where you hit all
three and that then diagram.
Speaker 2 (52:09):
Absolutely, and we feel with lung cancer we're there and
we're and we're going to have fallen.
Speaker 1 (52:13):
How long you know, not to put you on the spot,
but how long would it take to do another another cancer?
Is is it a multi year process or some of
that works I'm sure is probably already underway.
Speaker 2 (52:25):
Yeah, as I mentioned, I mean we've had publications already
on liver cancer and recently on ovarying cancer. So we
think the evidence base of you know, the test actually
performing well and another cancer is there, it would be
you know a matter of you know, actually launching an
l d T and then kind of going down the
path that we have. We think that you know, another
(52:47):
l d T could be as you know, as soon
as in a year. Oh wow, that quick, Yes, And
we're gonna we're going to paste that based on kind
of what are the most pressing opportunities for invest that
we have at the time. But I mentioned also that
we you know, we have studies going on internationally, there
could be cancer indications that would be better launched initially
(53:12):
internationally and then you know, kind of following the following
the kind of regulatory practices kind of in that country.
There are so many underserved cancers abroad. To mention, you know,
lung cancer abroad is a huge problem. Other served there's
so many countries that haven't even adopted scanning, so this
(53:36):
would be a leap frog for them. But there are
other cancers, like liver cancer in some countries in you know, Asia,
for instance, liver cancer is not just the deadliest cancer killer,
it's the deadliest killer above heart disease or anything else.
So we just see, I mean, like the opportunity to
make a difference is kind of boundless, especially when you
(53:58):
have a test that's low cast lost and uh one
that you know can be kind of transferred to the
you know, and the kind of easy way that ours is.
Speaker 1 (54:06):
Well, it's a great story, yeah, and thank you so
much for sharing it. The way I like to wrap
up these conversations that we touched on this probably a
little bit already is what drives the guests. You know,
what lessons have they learned in their life that they
like to apply to their day to day or share
with their teams. And so I think I know where
you're going to go with your answer, but I would
ask you that same question as well.
Speaker 2 (54:27):
Yeah, well, I'm a big believer in you know, the
kind of mission of a company. I guess, you know,
Simon Sinak, and like the why you know as like
the most important thing. I mean, there's what you do
and how you do it, Like the why why are
we here? What is the problem that we're solving? Is
the opportunity that we're addressing. I am so passionate about
(54:49):
making a difference in cancer. I mean, whose lives you
know have not been impacted by cancer? One? Cancer diagnosis
impacts not just that individual, but like everyone around them, society,
and you know, being able to you know, stop that
in its tracks at the earliest stage is like the
only way we're going to get there. And so I
(55:11):
think that lessons that I've learned are about when you
have something that's so important that can be so compelling
to a group of people, that we can bring together
a group of like incredibly capable motivated, dedicated people, which
I feel we have at Delphi like that like protecting
that and cultivating that and feeding that like that is
(55:33):
I'm absolutely passionate about that, and I think making that sustainable,
like making sure that like we never lose sight of
like the impact that we can make and firing that passion.
I think I mentioned that, you know, relentless drive and
making our tests better and having like tests that are
(55:55):
meeting the most unmet need like pursuit of progress in
this and I think that that is motivated by kind
of mission and values and culture more so than you
can ever do financially. I mean that will come to
like the mission I think is something that like the
sense of purpose that you give individuals is so overwhelmingly powerful.
(56:17):
So that's what I've learned. And so I mentioned like
building leadership of the team of the company that can
really you know, fire those passions and bring out the
best in our people to to you know, kind of
power that and drive progress. I think we're like just
(56:38):
like a relentless drive to have progress and make a difference.
Speaker 1 (56:42):
That was wonderful. I can tell your passion is very
very evident. Thank you so much for joining us. Today,
and I hope you'll come back in a couple of
years and tell us how our things are going.
Speaker 2 (56:50):
Thank you, Jonathan, it's been absolute pleasure.
Speaker 1 (56:53):
That's Susan two, c CEO of Delphi Diagnostics. Thank you
so much for joining us today for our latest episode.
Then please make sure to click the follow button on
your favorite podcast app so you never miss a discussion
with the leaders in healthcare innovation. I'm Jonathan Palmer, and
you've been listening to the Vanguards of Healthcare podcast by
Bloomberg Intelligence. Until next time, take care,
Host
Jonathan Palmer
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