March 27, 2024 • 25 mins
Today we interview with Dan Lunz, co-founder and CEO of Previse, an innovative medical solutions company specializing in cancer prevention and early detection. Lunz talks about his journey from being a Marine to leading a pioneering medical company. He discusses the scientific technology behind Previse, which started out as research for predicting esophageal cancer in patients with Barrett's esophagus. Lunz also shares about the company's current fundraising activities, commercialization plans, compliance with regulatory standards, and long-term goals for cancer detection. He hints at exciting future announcements about Previse's new developments, tests, and pipeline technologies.
https://previsedx.com/
https://www.linkedin.com/in/danlunz/
00:43 The Journey of Previse: Aiming for Early Cancer Detection
05:24 The Previse Technology: A New Approach to Cancer Detection
07:45 The Impact of Previse in the Medical Field
10:13 Fundraising and the Future of Previse
14:51 Navigating the Regulatory Landscape
18:02 Balancing Innovation and Compliance
21:15 Long-term Goals and Future Developments
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Music by keldez
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Transcript
Episode Transcript
Available transcripts are automatically generated. Complete accuracy is not guaranteed.
(00:01):
Hi there! Welcome to the FromLab to Launch podcast by Qualio,
where we share inspiring storiesfrom the people on the front
lines of life sciences.
Tune in and leave inspired tobring your life saving products
to the world.
Meg Sinclair (00:17):
Hi everyone.
And thanks for tuning into FromLab to Launch by Qualio.
I'm Meg, your host.
Glad to be here and reallyexcited for today's episode.
Before we get started, we'd loveit if you rated the podcast.
It's easy to do and share itwith any of your science nerd
friends.
We know you have some.
And if you'd like to be on theshow, please see the show notes
for an application.
(00:38):
Today, we're joined by Dan Lunz,co founder and CEO.
Previse.
Previse is a pioneering medicalsolutions company specializing
in the prevention and earlydetection of cancer, focusing
initially on esophageal cancer.
The Previse journey began as anexploration into a technology's
viability for predictingesophageal cancer in patients
(01:00):
with Barrett's esophagus, and itquickly revealed a genuine need
among gastroenterologists.
We'll get more background intothe We'll get more into the
background during the interview,and you can learn more about the
Previse in the show notes aswell.
Dan Lunz is a former US Marineand researcher at Johns Hopkins.
(01:20):
He's been leading Previse since2020, and we're excited to learn
more about his journey from labto launch.
So let's get to it.
Welcome to the show, Dan.
Dan Lunz (01:30):
Hi Meg.
Thank you for having me.
Meg Sinclair (01:32):
Yeah.
Can you share a little bit with,uh, can you share a little bit
with your journey about what ledyou from a Marine to the CEO of
Previse and what inspired you tofocus on early cancer detection?
Dan Lunz (01:45):
No, thank you for the question, Meg.
Um, so I joined the Marinesstraight out of high school and
real interest in serving God andserving my country.
And one of the things that, uh,that I found in my story and
impactful pieces is this, uh,this purpose that I feel to
serve others.
Um, so, so I served in theMarines from February, 2005 to
(02:08):
February, 2012.
Upon getting out I found my wayinto the VA hospital and, uh,
and as a patient, um, and itwas, Uh, military related, uh,
uh, health issues that I wentinto the VA for.
And that was my real firstexposure into health care.
(02:30):
I found an interest in themental health side and what's
called kinesiotherapy, usingexercise as a form of, uh, of
treatment for physical, mental,emotional, um, uh, conditions.
And that was my firstrealization that this is what I
wanted to do.
In some capacity, I.
Wanted to be involved in healthcare.
I didn't know if it wasphysician scientist what pathway
(02:53):
that would take So I ended upgoing and getting my undergrad
in exercise science Afterreceiving my undergrad I
transitioned to Johns HopkinsStarted working as a research
coordinator and interventionalpulmonology Got my MBA at Johns
Hopkins transitioned to a morelike clinical research network
(03:14):
position really Helping theadministrative side to develop
clinical research trials, uh,for therapeutics, for medical
devices and for diagnostics.
Um, and it was during this timethat I went to a Johns Hopkins
Tech Ventures.
Meeting and, uh, and there's thetech transfer office for Johns
Hopkins.
So the office where facultymembers will go in, uh, and
(03:38):
receive support, protectingtechnologies through, you know,
getting technologies patented,licensing out technologies or
starting companies.
And I went to that meeting and Iheard a gentleman share about a
technology.
He developed that he felt likegood.
could really impact patients,potentially save lives.
But as it stood, he felt likethis technology would just be in
(04:00):
some high impact journals, wouldjust really live within the
research realm.
Um, and that, that purpose kindof, you know, I heard that
purpose from him for servingothers.
And, uh, and I approached himafter that meeting.
That was Dr.
Steve Meltzer, my co founder.
He's a GI physician, uh,researcher at Johns Hopkins.
(04:20):
Um, and we spoke about thistechnology he developed for
patients with the pre malignantcondition, Barrett's esophagus,
um, and for detecting andpreventing esophageal cancer
about methylation biomarkers andmake it actually started off as
a free internship.
I said to him, Hey I don't knowmuch about this condition.
(04:42):
I don't know much aboutmethylation, but you know, I'm
interested in entrepreneurship.
I want to serve, I want to serveothers.
Maybe I can do some customerdiscovery.
And that's what really sparkedoff our, uh, our relationship.
And we started meeting regularlyand several months later, we,
uh.
Uh, we realized, wait this mightreally be an opportunity for us
to get something out there.
(05:02):
And that was the start ofPrevise.
Meg Sinclair (05:06):
What a cool journey that's been for you, um,
from Camp Pendleton all the wayto Johns Hopkins, from unpaid
internship to CEO now.
That's incredible.
Um, how does Previsedifferentiate itself in the
field of cancer detection,particularly with your ESO
predict test?
Dan Lunz (05:26):
Yeah.
So, so, um, we're really focusedon the prevention side.
So there's a lot of wonderfultechnologies coming out.
And, uh, you've heard of like amulti cancer, early detection
tests and blood tests fordetecting early cancer.
Um, there's a issue when itcomes to esophageal cancer.
And that's that even if foundlocal, even if it's stage one
(05:47):
disease, the five year survivalrate is 47%.
So even if you find it at theearliest stages, um, it's
oftentimes already too late.
So for esophageal cancer, thereis this what's believed to be
obligate precursor calledBarrett's esophagus.
And Barrett's esophagus occursin about 10 to 15 percent of
(06:09):
patients with chronic acidreflux or chronic GERD.
And, uh, so there's a largenumber of, individuals in the
United States who have Barrett'sesophagus and it's this
metaplastic change that'lloccur.
It's really quite incrediblethis change that the body will
make where the lower esophagusgoes from being like your skin,
this squamous epithelium.
(06:31):
to columnar cells, which is morelike your, uh, your stomach or
your intestines, which handlesacid much better.
Uh, the issue is that it putsyou at risk for developing
esophageal cancer.
It increases the likelihood, um,as much as 55 times.
for developing esophagealcancer.
So when a patient is diagnosedvia endoscopy with Barrett's
(06:54):
esophagus, they're put on asurveillance program, oftentimes
a lifetime surveillance program,to determine which patients are
likely to progress to esophagealcancer.
Um, now these samples are taken,these biopsy samples are taken,
pathology reviews them, and theysay whether they see any
abnormality called dysplasia.
(07:14):
Um, so what our test is able todo is to take that standard of
care biopsy sample, we only needone of the biopsy samples, we
take a few slices off of thatblock, we analyze it, we look at
DNA methylation of four specificgenes, we run it through our
algorithm, and we're able toproduce a five year risk score.
Uh, for that patient.
(07:36):
So personalized information forthat physician.
So we're the first and only DNAtest, uh, for Barrett's
esophagus prognosis.
Um, and it's been wonderful tosee the impact it's already
making in the clinic of GIpractices.
Meg Sinclair (07:53):
How widely distributed is it being used in
GI practices in
Dan Lunz (07:57):
the States?
Yeah, so, so, so we, uh, I'lltell you what, do you mind if I
don't go far down that path?
Meg Sinclair (08:07):
Sure, yeah.
Alright.
Sorry.
That was an ad lib question.
I'm sorry.
Dan Lunz (08:11):
It was, no, Meg, it was such a good question, but
it's funny because I we'refundraising and we're, uh, so
maybe we can say it.
Let me not throw numbers outthere.
Meg Sinclair (08:23):
Yeah, maybe, can I reframe the question of like,
how big has your impact been sofar in the GI space?
Yeah,
Dan Lunz (08:32):
yeah,
Meg Sinclair (08:32):
let's do it.
Okay.
So far, this sounds amazing,this technology, how wide has
your impact been in the GI spaceso
Dan Lunz (08:39):
far?
Yeah, so it's been wonderful tosee the, uh, the adoption and
really the rapid adoption in theclinic.
Um, we have a number of academicsites and, uh, and community
clinics who have adopted thistechnology.
One of the really cool emails wejust received last week from the
GI physician shared about apatient that they had who had
(09:03):
Familial history.
They had a brother who hadesophageal cancer and this
patient had this precancerousbarrett's esophagus and the
physician was trying todetermine what to do with this
patient.
Do we keep him on a surveillanceprogram?
Do we consider treatment?
At what frequency do we dosurveillance?
If we stay with surveillance?
Um, so they ordered our ESOpredict test and they received a
(09:25):
higher risk score.
It showed that this patient hada higher likelihood for
developing esophageal cancer inthe next five years.
Um, so they actually movedforward, spoke with the patient
about it and determined thatablation was the best pathway
forward.
So they were able to moveforward with that endoscopic
treatment.
It's an ambulatory treatment.
They're able to do, uh, uh, inthe endoscopy clinic.
(09:47):
Um, and potentially it's anothercancer prevented.
Meg Sinclair (09:53):
That's amazing.
That's such great impact andgreat to see such a great
adoption on a new technology.
Sometimes that's a difficulthurdle for new and emerging
technologies to have the valuepropositions and have clinics
and hospitals pick up theirtechnology.
But that's amazing.
The traction you guys havegotten already.
That's great.
Dan Lunz (10:11):
Oh, thank you.
Meg Sinclair (10:13):
Um, many founders on our show have interesting
stories about fundraising.
Can you share any fundraisingexperience you've had recently
and how you've worked to raisefunds to bring your products to
market?
Dan Lunz (10:24):
Yeah.
So, so, uh, so fundraisingjourney wise, you know, it's,
uh, it's funny cause I thinkback to our first investor that
came on, it was an angelinvestor and a successful
entrepreneur who, uh, whohimself was facing.
cancer.
He had a stage four cancerdiagnosis.
Um, and about five minutes afterhim, after I met him, um, he
(10:48):
said, I'm gonna, I'm gonnainvest in your company.
And, uh, and it was reallyaltruistic.
And he took a flyer.
On us and, uh, and things haveprogressed and changed a bit
since that first check that camein.
Um, so, so we are currentlyfundraising, um, and what we're
really focused now on is thepathway to more market adoption.
(11:09):
Uh, so commercial activities andthen what's called market access
and our reimbursement strategy,how we're going to, how we're
going to.
Uh, achieve what's called localcoverage determination with
Medicare and with private payersas well.
So it's, uh, so our story hasreally transitioned from the
early altruistic days of, Hey,this is something that could
potentially save lives to nowsaying, Okay, this is how we're
(11:32):
actually going to execute onthis strategy.
Meg Sinclair (11:36):
Yeah, such an important piece of that puzzle,
getting the payers to pay for itfor the product.
Oh, yeah, the patients want it,but the payers have to pay for
it to make it happen, right?
Um, wonderful.
Are there plans to expandPrevise's technology to other
forms of
Dan Lunz (11:53):
cancer?
Yeah, so, so we, uh, we'retaking a broader view both with
oncology cancer and then alsowith other upper GI conditions.
So, uh, so one of the thingsthat, that we've been really
fortunate with is, uh, isreceiving, uh, non dilutive
funding as well.
So there's these NIH grantscalled SBIR, Small Business
(12:15):
Innovative Research Grants.
Um, so we just received the 1.
8 million grant, uh, to conductfurther studies, uh, with our
ESOPREDICT test.
But also we've been fortunate toreceive NIH grant funding for
our pipeline technologies.
And then one of the, uh, one ofthe things that we're looking at
is how can we do this nonendoscopically?
(12:36):
So we started off with endoscopyand these biopsy samples and
risk stratifying patients, butit still requires an endoscopy.
And there's another issue, whichis the detection.
of that Barrett's esophagus.
So we, uh, we have a, uh, wecall it a sponge on a string
device that we've developed,which the patient swallows a
(12:56):
capsule, sits in the stomach forfive minutes, and it has a
string we're able to, uh, uh,pull, or I'm sorry, the capsule
reveals the sponge.
We're able to pull the spongeout via a string.
It's a five minute procedure, areally painless procedure for
the patient.
But from that, we're able toanalyze, uh, DNA and other
markers, and we're evaluating,uh, uh, early detection of
(13:18):
Barrett's esophagus and the twoprimary types of esophageal
cancer, adenocarcinoma andsquamous cell.
Um, one of the things that Ithink is really exciting is that
through these NIH fundedstudies, we're doing work here
in The United States at multiplesites, also in Europe.
Um, and then also in East Africaand lower and moderate income
(13:39):
countries such as Uganda andTanzania, where we're squamous
cell carcinoma is one of theleading causes of mortality and
men.
Um, so, so looking at how do wetouch patients along this
journey?
And then we're also evaluatingother conditions such as, uh,
stomach cancer and throat canceras well.
Meg Sinclair (14:00):
That's amazing.
Um, seems like a lot ofapplications and lots of cancers
that can be prevented throughyour technology.
Um, great.
Is there anything else we canexpect in terms of new
developments or new tests in thenear future from Previse?
Dan Lunz (14:19):
Yeah, so we have some exciting announcements that will
be coming out this year, uh, uh,publications for ESO predicts,
but also for our pipelinetechnologies and some news that
will be coming out about ourmedical device.
Um, also about our assays andtests in development.
Um, so, so it's 2024 is a reallyexciting year for us.
Meg Sinclair (14:40):
Well, I will be staying tuned for all that
exciting news from Previse.
At, here at Qualio, we providean eQMS software.
Um, so quality is always nearand dear to our hearts, mine
especially.
Um, but most founders don't havea quality or regulatory
background when they start andcan get caught off guard with
regulations.
Um, as Such in the medicaldevice industry.
(15:01):
So we like to ask founders likeyourself about your journey
through the quality andregulatory landscape and how
you've navigated that, gettingyour product to market.
Dan Lunz (15:10):
Yeah, so, so when we started, no and a really
important question.
And, uh, and you know, when Istarted when we started Provise,
um, it was something that Iknew.
Really nothing about.
We saw this cool technology thatwe felt like could make an
impact with patients.
Um, and it was all of thosereasons we were diving in.
(15:31):
And I remember, uh, speaking toa founder of, uh, of another
diagnostics company here inBaltimore, and they told me
about a CLIA lab.
And, uh, and I had never heardthis term before, so I remember
going home, running home andGoogling and trying to learn
everything I could about a Cliolab.
And, uh, and I remember, Meg, itwas funny we started and
(15:52):
actually, uh, one of the teammembers who helped us, uh,
develop our Clio lab.
One of the first discussions Ihad with her when we were first
thinking about getting thiscompany going was, hey, what is
this Clio lab?
They speak of so so so you hitthe nail on the head when you
talked about founders who don'thave experience in that
(16:13):
regulatory realm, very importantrealm.
Um, so, so we were able to bringon the proper support to develop
our CLIA lab, um, and toundergo, uh, developing SOPs,
our quality management.
Systems, quality controls andget those in place and beyond
clinical validation, which iswhat we often think about in the
(16:35):
academic universe, diving inwith the analytical validation
and how do we take this cooldata and good data that we may
have seen in the academic realmin a research lab and how do we
transition that into a clinicallab where you might be doing a
large volume of testing per dayin different patients And
(16:56):
ensuring that you're gettingconsistent, uh, results that you
can trust for those patients.
Um, and it was quite a journeylearning about it.
So, so, uh, uh, I'm grateful toshare that, that, you know, we
were able to bring on the properexpertise.
I learned a whole lot more and Igot a wonderful, uh, uh, group
(17:16):
around me, a team around me, uh,that's been able to Uh, you so
predict validation studiesanalytically and clinical
validation studies and put ourQ.
M.
S.
Systems in place.
So we've gone through our clearcompliance, uh, inspections and
being able to get clear in allstates.
Uh, not New York state yet, butin all other states.
(17:39):
Um, so we're launching as alaboratory developed test.
So really pleased with wherewe've been able to get with
that.
Meg Sinclair (17:47):
Amazing journey from what is this clear to
throwing out all the acronymslike Q.
M.
S.
F.
D.
A.
Party 20.
All of that.
So lovely to see that journeyfrom a CEO and founder, um,
related to quality andinnovation.
How does provide strike abalance between pushing the
boundaries of medical technologyand ensuring compliance with
(18:08):
those
Dan Lunz (18:09):
regulatory standards?
Yeah, no, and this is a, uh,it's a really good question
because there are there, thereare universes, you know, when
you think of innovation and whenyou think of developing a
consistent high qualityperforming test, uh, it's
sometimes hard to connect that,you know, in the research around
(18:31):
when we're looking atinnovating, um, you might be
modifying your proceduresregularly.
You might be, you know, you'redoing DNA extraction one way.
Okay.
And you learn about a differentprotocol, or you modify the
temperatures a little bit, orwhatever it may be, uh, the time
that it's sitting in, some kindof solution, um, and you say,
okay, hey let's make thischange.
(18:52):
This works better.
And you're constantly innovatingand optimizing.
And, uh, and, you know, if I candare to say, uh, uh, toying
around.
A little bit, and it's reallyabout okay, demonstrating in
early biomarker discovery andvalidation that, hey, this
works.
Look, we've got good what'scalled area under the curves or
(19:13):
sensitivity and specificity inthis limited case control
setting, um, but it's, you know,and getting that next research
paper published and showing theinnovation and maybe going for
grant funding for thatinnovation.
Um.
Whereas in the clinical lab, uh,you know, I heard a founder of
(19:35):
a, of another company here inBaltimore diagnostics company
who shared that one of thetoughest things for him.
He's a PhD scientist.
He shared that one of thetoughest things for him was to
come to that place where he hadto release control.
And had to let kind of his baby,if you will, something he had
been, you know, working on foryears and investing so much time
(20:00):
and, uh, and coming to a placewhere, okay, it's time to
release it so that now it can gointo that next step into product
development and being developedinto a clinically usable.
Product, um, so, one of thethings that, uh, that we found
is the earlier that we can getinvolved, be involved with
(20:21):
technologies that are just beinginvented or assays that are just
being discovered the better sothat we can start putting into
place some analytical testing,start looking at, okay, how will
this really translate into theclinical realm?
You know, uh, how do we start tolock down procedures and just to
have wonderful interactions withpeople on the research side and
(20:46):
on the discovery side and peoplein, uh, in the clinical lab that
are more on the regulatory side.
So I think one of the keys forsuccess that for us, at least,
is the earlier is the better andthe clear communication.
Um, and then that's really beena key for us.
Meg Sinclair (21:06):
Thanks for sharing that.
That's a great, that's greatadvice.
I think for the starting outtrying to find that balance
earlier is better to bring inthe quality and strike that
balance.
Um, so we talked about kind ofnew things coming in the near
future.
Do you see, um, any long termgoals around cancer detection
and provides that you want toshare in the next 5 to 10 years,
big dreams for the organization.
Dan Lunz (21:29):
Yeah, so, so really focused right now on getting ESO
predict out there and how can weimpact more lives?
How can we, uh, increaseadoption, make it more
accessible for patients?
So, like we talked about, uh,that's on the commercial front,
but also on the reimbursementfront and getting coverage
becoming in network test.
Um, with different payers.
(21:49):
Um, and then along with that,looking for different avenues
that we can bring otherclinically relevant and
important tests to market thatare, uh, that are going to make
a difference in patient care.
You know, we talked about themulti cancer early detection,
but I think one of the thingsthat, uh, That has been really
interesting to see in the pastcouple years is a return by a
(22:10):
lot of companies to focusingmore so on specific cancers or
specific indication.
You're seeing a lot of, uh,minimal, uh, residual disease
testing focused on, you know,starting off with a specific
cancer, whether it be coloncancer, lung cancer.
Um, and what we find is in theregulatory front, you know, the
(22:30):
FDA front on the payer front,uh, it's currently more so
built.
Our system is more so built forthat.
So it'll be wonderful to see notonly the innovation from
companies like provides, butalso as we go through and the
FDA continues to try to, uh,iterate and innovate and as
payers try to come around and,uh, and develop pathways for
(22:52):
getting the necessary clinicalanalytical control.
Uh, validation data and clinicalutility data.
So I think it's really, uh,going to be quite wonderful to
see, uh, us as an ecosystemmoving in that direction over
the next 5 10 years.
Meg Sinclair (23:08):
I hope the healthcare system
Dan Lunz (23:10):
moves that quickly.
Meg Sinclair (23:12):
I'm hopeful.
I'm hopeful.
Um, our last question is more ofa fun one.
We love to ask each of ourguests at the end of the show,
if we ran into you at thebookstore or at your local
library, Dan, in what sectionwould we find you?
Dan Lunz (23:27):
So, so I am a big history buff and I love
biographies.
Um, so I've done deep dives onBenjamin Franklin and, uh, and
different Walter Isakson, um,biographies.
So I, I start a lot ofbiographies.
(23:47):
I don't finish as many as Istart, but very likely that's
where you'd find me.
Meg Sinclair (23:52):
Okay.
Wonderful.
Well, thanks so much forsharing.
Dan Lunz (23:56):
What about you?
Oh,
Meg Sinclair (23:58):
I also am a big biography buff.
I always like reading aboutpeople's lives.
Um, And the one on my bookshelfright now is Hedy Lamarr, an
actress and innovator.
So, um, I'm saving that one formy March women's history read.
So, but probably the samehistory and biographies are my
thing these days.
Dan Lunz (24:18):
Awesome.
And I'll have to pick that bookup.
Meg Sinclair (24:21):
Yeah, I'll send it over to you.
Um, for our folks wanting tolearn more about Previse and
yourself, where can they goalong to follow along on your
progress?
Dan Lunz (24:30):
Yeah, please check us out at Previsedx, like
diagnostics.
com.
Um, you can also look us up onLinkedIn, Prevised Diagnostics,
um, or me, you'll see me onLinkedIn, Daniel Lunz, and
please connect with me.
Meg Sinclair (24:46):
Perfect.
Yeah, we'll post all those inthe show notes and we'll get
connected and I'll send you thatbiography on Hedy Lamarr.
Dan Lunz (24:53):
Awesome.
Thank you so much, Meg.
Thank you for listening to thisweek's episode of From Lab to
Launch, brought to you byQualio.
If you like what you've heard,please subscribe and give the
show a positive review.
It really helps us out.
For more information aboutQualio, our guest today, or to
be a guest on a future episode,please refer to the show notes.
(25:15):
Until next time.
Hi there! Welcome to the FromLab to Launch podcast by Qualio,
where we share inspiring storiesfrom the people on the front
lines of life sciences.
Tune in and leave inspired tobring your life saving products
to the world.
Meg Sinclair (00:17):
Hi everyone.
And thanks for tuning into FromLab to Launch by Qualio.
I'm Meg, your host.
Glad to be here and reallyexcited for today's episode.
Before we get started, we'd loveit if you rated the podcast.
It's easy to do and share itwith any of your science nerd
friends.
We know you have some.
And if you'd like to be on theshow, please see the show notes
for an application.
(00:38):
Today, we're joined by Dan Lunz,co founder and CEO.
Previse.
Previse is a pioneering medicalsolutions company specializing
in the prevention and earlydetection of cancer, focusing
initially on esophageal cancer.
The Previse journey began as anexploration into a technology's
viability for predictingesophageal cancer in patients
(01:00):
with Barrett's esophagus, and itquickly revealed a genuine need
among gastroenterologists.
We'll get more background intothe We'll get more into the
background during the interview,and you can learn more about the
Previse in the show notes aswell.
Dan Lunz is a former US Marineand researcher at Johns Hopkins.
(01:20):
He's been leading Previse since2020, and we're excited to learn
more about his journey from labto launch.
So let's get to it.
Welcome to the show, Dan.
Dan Lunz (01:30):
Hi Meg.
Thank you for having me.
Meg Sinclair (01:32):
Yeah.
Can you share a little bit with,uh, can you share a little bit
with your journey about what ledyou from a Marine to the CEO of
Previse and what inspired you tofocus on early cancer detection?
Dan Lunz (01:45):
No, thank you for the question, Meg.
Um, so I joined the Marinesstraight out of high school and
real interest in serving God andserving my country.
And one of the things that, uh,that I found in my story and
impactful pieces is this, uh,this purpose that I feel to
serve others.
Um, so, so I served in theMarines from February, 2005 to
(02:08):
February, 2012.
Upon getting out I found my wayinto the VA hospital and, uh,
and as a patient, um, and itwas, Uh, military related, uh,
uh, health issues that I wentinto the VA for.
And that was my real firstexposure into health care.
(02:30):
I found an interest in themental health side and what's
called kinesiotherapy, usingexercise as a form of, uh, of
treatment for physical, mental,emotional, um, uh, conditions.
And that was my firstrealization that this is what I
wanted to do.
In some capacity, I.
Wanted to be involved in healthcare.
I didn't know if it wasphysician scientist what pathway
(02:53):
that would take So I ended upgoing and getting my undergrad
in exercise science Afterreceiving my undergrad I
transitioned to Johns HopkinsStarted working as a research
coordinator and interventionalpulmonology Got my MBA at Johns
Hopkins transitioned to a morelike clinical research network
(03:14):
position really Helping theadministrative side to develop
clinical research trials, uh,for therapeutics, for medical
devices and for diagnostics.
Um, and it was during this timethat I went to a Johns Hopkins
Tech Ventures.
Meeting and, uh, and there's thetech transfer office for Johns
Hopkins.
So the office where facultymembers will go in, uh, and
(03:38):
receive support, protectingtechnologies through, you know,
getting technologies patented,licensing out technologies or
starting companies.
And I went to that meeting and Iheard a gentleman share about a
technology.
He developed that he felt likegood.
could really impact patients,potentially save lives.
But as it stood, he felt likethis technology would just be in
(04:00):
some high impact journals, wouldjust really live within the
research realm.
Um, and that, that purpose kindof, you know, I heard that
purpose from him for servingothers.
And, uh, and I approached himafter that meeting.
That was Dr.
Steve Meltzer, my co founder.
He's a GI physician, uh,researcher at Johns Hopkins.
(04:20):
Um, and we spoke about thistechnology he developed for
patients with the pre malignantcondition, Barrett's esophagus,
um, and for detecting andpreventing esophageal cancer
about methylation biomarkers andmake it actually started off as
a free internship.
I said to him, Hey I don't knowmuch about this condition.
(04:42):
I don't know much aboutmethylation, but you know, I'm
interested in entrepreneurship.
I want to serve, I want to serveothers.
Maybe I can do some customerdiscovery.
And that's what really sparkedoff our, uh, our relationship.
And we started meeting regularlyand several months later, we,
uh.
Uh, we realized, wait this mightreally be an opportunity for us
to get something out there.
(05:02):
And that was the start ofPrevise.
Meg Sinclair (05:06):
What a cool journey that's been for you, um,
from Camp Pendleton all the wayto Johns Hopkins, from unpaid
internship to CEO now.
That's incredible.
Um, how does Previsedifferentiate itself in the
field of cancer detection,particularly with your ESO
predict test?
Dan Lunz (05:26):
Yeah.
So, so, um, we're really focusedon the prevention side.
So there's a lot of wonderfultechnologies coming out.
And, uh, you've heard of like amulti cancer, early detection
tests and blood tests fordetecting early cancer.
Um, there's a issue when itcomes to esophageal cancer.
And that's that even if foundlocal, even if it's stage one
(05:47):
disease, the five year survivalrate is 47%.
So even if you find it at theearliest stages, um, it's
oftentimes already too late.
So for esophageal cancer, thereis this what's believed to be
obligate precursor calledBarrett's esophagus.
And Barrett's esophagus occursin about 10 to 15 percent of
(06:09):
patients with chronic acidreflux or chronic GERD.
And, uh, so there's a largenumber of, individuals in the
United States who have Barrett'sesophagus and it's this
metaplastic change that'lloccur.
It's really quite incrediblethis change that the body will
make where the lower esophagusgoes from being like your skin,
this squamous epithelium.
(06:31):
to columnar cells, which is morelike your, uh, your stomach or
your intestines, which handlesacid much better.
Uh, the issue is that it putsyou at risk for developing
esophageal cancer.
It increases the likelihood, um,as much as 55 times.
for developing esophagealcancer.
So when a patient is diagnosedvia endoscopy with Barrett's
(06:54):
esophagus, they're put on asurveillance program, oftentimes
a lifetime surveillance program,to determine which patients are
likely to progress to esophagealcancer.
Um, now these samples are taken,these biopsy samples are taken,
pathology reviews them, and theysay whether they see any
abnormality called dysplasia.
(07:14):
Um, so what our test is able todo is to take that standard of
care biopsy sample, we only needone of the biopsy samples, we
take a few slices off of thatblock, we analyze it, we look at
DNA methylation of four specificgenes, we run it through our
algorithm, and we're able toproduce a five year risk score.
Uh, for that patient.
(07:36):
So personalized information forthat physician.
So we're the first and only DNAtest, uh, for Barrett's
esophagus prognosis.
Um, and it's been wonderful tosee the impact it's already
making in the clinic of GIpractices.
Meg Sinclair (07:53):
How widely distributed is it being used in
GI practices in
Dan Lunz (07:57):
the States?
Yeah, so, so, so we, uh, I'lltell you what, do you mind if I
don't go far down that path?
Meg Sinclair (08:07):
Sure, yeah.
Alright.
Sorry.
That was an ad lib question.
I'm sorry.
Dan Lunz (08:11):
It was, no, Meg, it was such a good question, but
it's funny because I we'refundraising and we're, uh, so
maybe we can say it.
Let me not throw numbers outthere.
Meg Sinclair (08:23):
Yeah, maybe, can I reframe the question of like,
how big has your impact been sofar in the GI space?
Yeah,
Dan Lunz (08:32):
yeah,
Meg Sinclair (08:32):
let's do it.
Okay.
So far, this sounds amazing,this technology, how wide has
your impact been in the GI spaceso
Dan Lunz (08:39):
far?
Yeah, so it's been wonderful tosee the, uh, the adoption and
really the rapid adoption in theclinic.
Um, we have a number of academicsites and, uh, and community
clinics who have adopted thistechnology.
One of the really cool emails wejust received last week from the
GI physician shared about apatient that they had who had
(09:03):
Familial history.
They had a brother who hadesophageal cancer and this
patient had this precancerousbarrett's esophagus and the
physician was trying todetermine what to do with this
patient.
Do we keep him on a surveillanceprogram?
Do we consider treatment?
At what frequency do we dosurveillance?
If we stay with surveillance?
Um, so they ordered our ESOpredict test and they received a
(09:25):
higher risk score.
It showed that this patient hada higher likelihood for
developing esophageal cancer inthe next five years.
Um, so they actually movedforward, spoke with the patient
about it and determined thatablation was the best pathway
forward.
So they were able to moveforward with that endoscopic
treatment.
It's an ambulatory treatment.
They're able to do, uh, uh, inthe endoscopy clinic.
(09:47):
Um, and potentially it's anothercancer prevented.
Meg Sinclair (09:53):
That's amazing.
That's such great impact andgreat to see such a great
adoption on a new technology.
Sometimes that's a difficulthurdle for new and emerging
technologies to have the valuepropositions and have clinics
and hospitals pick up theirtechnology.
But that's amazing.
The traction you guys havegotten already.
That's great.
Dan Lunz (10:11):
Oh, thank you.
Meg Sinclair (10:13):
Um, many founders on our show have interesting
stories about fundraising.
Can you share any fundraisingexperience you've had recently
and how you've worked to raisefunds to bring your products to
market?
Dan Lunz (10:24):
Yeah.
So, so, uh, so fundraisingjourney wise, you know, it's,
uh, it's funny cause I thinkback to our first investor that
came on, it was an angelinvestor and a successful
entrepreneur who, uh, whohimself was facing.
cancer.
He had a stage four cancerdiagnosis.
Um, and about five minutes afterhim, after I met him, um, he
(10:48):
said, I'm gonna, I'm gonnainvest in your company.
And, uh, and it was reallyaltruistic.
And he took a flyer.
On us and, uh, and things haveprogressed and changed a bit
since that first check that camein.
Um, so, so we are currentlyfundraising, um, and what we're
really focused now on is thepathway to more market adoption.
(11:09):
Uh, so commercial activities andthen what's called market access
and our reimbursement strategy,how we're going to, how we're
going to.
Uh, achieve what's called localcoverage determination with
Medicare and with private payersas well.
So it's, uh, so our story hasreally transitioned from the
early altruistic days of, Hey,this is something that could
potentially save lives to nowsaying, Okay, this is how we're
(11:32):
actually going to execute onthis strategy.
Meg Sinclair (11:36):
Yeah, such an important piece of that puzzle,
getting the payers to pay for itfor the product.
Oh, yeah, the patients want it,but the payers have to pay for
it to make it happen, right?
Um, wonderful.
Are there plans to expandPrevise's technology to other
forms of
Dan Lunz (11:53):
cancer?
Yeah, so, so we, uh, we'retaking a broader view both with
oncology cancer and then alsowith other upper GI conditions.
So, uh, so one of the thingsthat, that we've been really
fortunate with is, uh, isreceiving, uh, non dilutive
funding as well.
So there's these NIH grantscalled SBIR, Small Business
(12:15):
Innovative Research Grants.
Um, so we just received the 1.
8 million grant, uh, to conductfurther studies, uh, with our
ESOPREDICT test.
But also we've been fortunate toreceive NIH grant funding for
our pipeline technologies.
And then one of the, uh, one ofthe things that we're looking at
is how can we do this nonendoscopically?
(12:36):
So we started off with endoscopyand these biopsy samples and
risk stratifying patients, butit still requires an endoscopy.
And there's another issue, whichis the detection.
of that Barrett's esophagus.
So we, uh, we have a, uh, wecall it a sponge on a string
device that we've developed,which the patient swallows a
(12:56):
capsule, sits in the stomach forfive minutes, and it has a
string we're able to, uh, uh,pull, or I'm sorry, the capsule
reveals the sponge.
We're able to pull the spongeout via a string.
It's a five minute procedure, areally painless procedure for
the patient.
But from that, we're able toanalyze, uh, DNA and other
markers, and we're evaluating,uh, uh, early detection of
(13:18):
Barrett's esophagus and the twoprimary types of esophageal
cancer, adenocarcinoma andsquamous cell.
Um, one of the things that Ithink is really exciting is that
through these NIH fundedstudies, we're doing work here
in The United States at multiplesites, also in Europe.
Um, and then also in East Africaand lower and moderate income
(13:39):
countries such as Uganda andTanzania, where we're squamous
cell carcinoma is one of theleading causes of mortality and
men.
Um, so, so looking at how do wetouch patients along this
journey?
And then we're also evaluatingother conditions such as, uh,
stomach cancer and throat canceras well.
Meg Sinclair (14:00):
That's amazing.
Um, seems like a lot ofapplications and lots of cancers
that can be prevented throughyour technology.
Um, great.
Is there anything else we canexpect in terms of new
developments or new tests in thenear future from Previse?
Dan Lunz (14:19):
Yeah, so we have some exciting announcements that will
be coming out this year, uh, uh,publications for ESO predicts,
but also for our pipelinetechnologies and some news that
will be coming out about ourmedical device.
Um, also about our assays andtests in development.
Um, so, so it's 2024 is a reallyexciting year for us.
Meg Sinclair (14:40):
Well, I will be staying tuned for all that
exciting news from Previse.
At, here at Qualio, we providean eQMS software.
Um, so quality is always nearand dear to our hearts, mine
especially.
Um, but most founders don't havea quality or regulatory
background when they start andcan get caught off guard with
regulations.
Um, as Such in the medicaldevice industry.
(15:01):
So we like to ask founders likeyourself about your journey
through the quality andregulatory landscape and how
you've navigated that, gettingyour product to market.
Dan Lunz (15:10):
Yeah, so, so when we started, no and a really
important question.
And, uh, and you know, when Istarted when we started Provise,
um, it was something that Iknew.
Really nothing about.
We saw this cool technology thatwe felt like could make an
impact with patients.
Um, and it was all of thosereasons we were diving in.
(15:31):
And I remember, uh, speaking toa founder of, uh, of another
diagnostics company here inBaltimore, and they told me
about a CLIA lab.
And, uh, and I had never heardthis term before, so I remember
going home, running home andGoogling and trying to learn
everything I could about a Cliolab.
And, uh, and I remember, Meg, itwas funny we started and
(15:52):
actually, uh, one of the teammembers who helped us, uh,
develop our Clio lab.
One of the first discussions Ihad with her when we were first
thinking about getting thiscompany going was, hey, what is
this Clio lab?
They speak of so so so you hitthe nail on the head when you
talked about founders who don'thave experience in that
(16:13):
regulatory realm, very importantrealm.
Um, so, so we were able to bringon the proper support to develop
our CLIA lab, um, and toundergo, uh, developing SOPs,
our quality management.
Systems, quality controls andget those in place and beyond
clinical validation, which iswhat we often think about in the
(16:35):
academic universe, diving inwith the analytical validation
and how do we take this cooldata and good data that we may
have seen in the academic realmin a research lab and how do we
transition that into a clinicallab where you might be doing a
large volume of testing per dayin different patients And
(16:56):
ensuring that you're gettingconsistent, uh, results that you
can trust for those patients.
Um, and it was quite a journeylearning about it.
So, so, uh, uh, I'm grateful toshare that, that, you know, we
were able to bring on the properexpertise.
I learned a whole lot more and Igot a wonderful, uh, uh, group
(17:16):
around me, a team around me, uh,that's been able to Uh, you so
predict validation studiesanalytically and clinical
validation studies and put ourQ.
M.
S.
Systems in place.
So we've gone through our clearcompliance, uh, inspections and
being able to get clear in allstates.
Uh, not New York state yet, butin all other states.
(17:39):
Um, so we're launching as alaboratory developed test.
So really pleased with wherewe've been able to get with
that.
Meg Sinclair (17:47):
Amazing journey from what is this clear to
throwing out all the acronymslike Q.
M.
S.
F.
D.
A.
Party 20.
All of that.
So lovely to see that journeyfrom a CEO and founder, um,
related to quality andinnovation.
How does provide strike abalance between pushing the
boundaries of medical technologyand ensuring compliance with
(18:08):
those
Dan Lunz (18:09):
regulatory standards?
Yeah, no, and this is a, uh,it's a really good question
because there are there, thereare universes, you know, when
you think of innovation and whenyou think of developing a
consistent high qualityperforming test, uh, it's
sometimes hard to connect that,you know, in the research around
(18:31):
when we're looking atinnovating, um, you might be
modifying your proceduresregularly.
You might be, you know, you'redoing DNA extraction one way.
Okay.
And you learn about a differentprotocol, or you modify the
temperatures a little bit, orwhatever it may be, uh, the time
that it's sitting in, some kindof solution, um, and you say,
okay, hey let's make thischange.
(18:52):
This works better.
And you're constantly innovatingand optimizing.
And, uh, and, you know, if I candare to say, uh, uh, toying
around.
A little bit, and it's reallyabout okay, demonstrating in
early biomarker discovery andvalidation that, hey, this
works.
Look, we've got good what'scalled area under the curves or
(19:13):
sensitivity and specificity inthis limited case control
setting, um, but it's, you know,and getting that next research
paper published and showing theinnovation and maybe going for
grant funding for thatinnovation.
Um.
Whereas in the clinical lab, uh,you know, I heard a founder of
(19:35):
a, of another company here inBaltimore diagnostics company
who shared that one of thetoughest things for him.
He's a PhD scientist.
He shared that one of thetoughest things for him was to
come to that place where he hadto release control.
And had to let kind of his baby,if you will, something he had
been, you know, working on foryears and investing so much time
(20:00):
and, uh, and coming to a placewhere, okay, it's time to
release it so that now it can gointo that next step into product
development and being developedinto a clinically usable.
Product, um, so, one of thethings that, uh, that we found
is the earlier that we can getinvolved, be involved with
(20:21):
technologies that are just beinginvented or assays that are just
being discovered the better sothat we can start putting into
place some analytical testing,start looking at, okay, how will
this really translate into theclinical realm?
You know, uh, how do we start tolock down procedures and just to
have wonderful interactions withpeople on the research side and
(20:46):
on the discovery side and peoplein, uh, in the clinical lab that
are more on the regulatory side.
So I think one of the keys forsuccess that for us, at least,
is the earlier is the better andthe clear communication.
Um, and then that's really beena key for us.
Meg Sinclair (21:06):
Thanks for sharing that.
That's a great, that's greatadvice.
I think for the starting outtrying to find that balance
earlier is better to bring inthe quality and strike that
balance.
Um, so we talked about kind ofnew things coming in the near
future.
Do you see, um, any long termgoals around cancer detection
and provides that you want toshare in the next 5 to 10 years,
big dreams for the organization.
Dan Lunz (21:29):
Yeah, so, so really focused right now on getting ESO
predict out there and how can weimpact more lives?
How can we, uh, increaseadoption, make it more
accessible for patients?
So, like we talked about, uh,that's on the commercial front,
but also on the reimbursementfront and getting coverage
becoming in network test.
Um, with different payers.
(21:49):
Um, and then along with that,looking for different avenues
that we can bring otherclinically relevant and
important tests to market thatare, uh, that are going to make
a difference in patient care.
You know, we talked about themulti cancer early detection,
but I think one of the thingsthat, uh, That has been really
interesting to see in the pastcouple years is a return by a
(22:10):
lot of companies to focusingmore so on specific cancers or
specific indication.
You're seeing a lot of, uh,minimal, uh, residual disease
testing focused on, you know,starting off with a specific
cancer, whether it be coloncancer, lung cancer.
Um, and what we find is in theregulatory front, you know, the
(22:30):
FDA front on the payer front,uh, it's currently more so
built.
Our system is more so built forthat.
So it'll be wonderful to see notonly the innovation from
companies like provides, butalso as we go through and the
FDA continues to try to, uh,iterate and innovate and as
payers try to come around and,uh, and develop pathways for
(22:52):
getting the necessary clinicalanalytical control.
Uh, validation data and clinicalutility data.
So I think it's really, uh,going to be quite wonderful to
see, uh, us as an ecosystemmoving in that direction over
the next 5 10 years.
Meg Sinclair (23:08):
I hope the healthcare system
Dan Lunz (23:10):
moves that quickly.
Meg Sinclair (23:12):
I'm hopeful.
I'm hopeful.
Um, our last question is more ofa fun one.
We love to ask each of ourguests at the end of the show,
if we ran into you at thebookstore or at your local
library, Dan, in what sectionwould we find you?
Dan Lunz (23:27):
So, so I am a big history buff and I love
biographies.
Um, so I've done deep dives onBenjamin Franklin and, uh, and
different Walter Isakson, um,biographies.
So I, I start a lot ofbiographies.
(23:47):
I don't finish as many as Istart, but very likely that's
where you'd find me.
Meg Sinclair (23:52):
Okay.
Wonderful.
Well, thanks so much forsharing.
Dan Lunz (23:56):
What about you?
Oh,
Meg Sinclair (23:58):
I also am a big biography buff.
I always like reading aboutpeople's lives.
Um, And the one on my bookshelfright now is Hedy Lamarr, an
actress and innovator.
So, um, I'm saving that one formy March women's history read.
So, but probably the samehistory and biographies are my
thing these days.
Dan Lunz (24:18):
Awesome.
And I'll have to pick that bookup.
Meg Sinclair (24:21):
Yeah, I'll send it over to you.
Um, for our folks wanting tolearn more about Previse and
yourself, where can they goalong to follow along on your
progress?
Dan Lunz (24:30):
Yeah, please check us out at Previsedx, like
diagnostics.
com.
Um, you can also look us up onLinkedIn, Prevised Diagnostics,
um, or me, you'll see me onLinkedIn, Daniel Lunz, and
please connect with me.
Meg Sinclair (24:46):
Perfect.
Yeah, we'll post all those inthe show notes and we'll get
connected and I'll send you thatbiography on Hedy Lamarr.
Dan Lunz (24:53):
Awesome.
Thank you so much, Meg.
Thank you for listening to thisweek's episode of From Lab to
Launch, brought to you byQualio.
If you like what you've heard,please subscribe and give the
show a positive review.
It really helps us out.
For more information aboutQualio, our guest today, or to
be a guest on a future episode,please refer to the show notes.
(25:15):
Until next time.
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