September 18, 2025 • 44 mins
“Our vision as a company is to help eradicate cancer with tests that prevent it, detect it earlier and guide treatment,” says Kevin Conroy, CEO of Exact Sciences. He joins Bloomberg Intelligence analyst Jonathan Palmer on the Vanguards of Health Care podcast to trace Exact’s journey into a cancer-diagnostics leader. From Cologuard’s initial rise to its recently launched Cologuard Plus test, the debut of Cancerguard and expansion into minimal-residual disease (MRD) testing, Conroy shares how science, technology and culture underpin the company’s next decade.
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Episode Transcript
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Speaker 1 (00:17):
Welcome to another episode of Boomberg Intelligences Vanguards of Healthcare podcasts,
where we speak 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. I'm thrilled to welcome today's guest,
Kevin Conroy, the chairman and chief executive officer of Exact Sciences.
Exact is a leader in cancer diagnostics, and our listeners
(00:38):
will know it from its flagship coal of Guard screening
test for coorectal cancer, which generates more than two billion
in annual revenue. But Exact is more than just COLO Guard.
There's ancotype DX, risk Guard, onco Detect, onco Extra, and
just this week they've announced the launch of Cancer Guard,
the company's entree into the multi cancer early detection space.
Welcome to the podcast, Kevin.
Speaker 2 (00:59):
Thank you, Jonathan. It's great to be here.
Speaker 1 (01:02):
So before we dive into the present day and there's
a lot going on, I just wanted to maybe start
with the remarkable journey that you've you know, shepherded the
company through. It's really a profound transformation a lot of
folks might not really remember this, but Exact's first stool
cancer stool based cancer test, Pregen plus, you know, was
discontinued in two thousand and eight, and then you came
(01:22):
on in two thousand and nine. So maybe from a
high level, can you walk us through the evolution of
the company from when you first came on all those
years ago.
Speaker 2 (01:31):
Yeah. I joined after a meeting with doctor David Alquist
at the Mail Clinic. And Dave was a pre eminent researcher,
clinician many times funded by NIH and NCI, and his
passion was cancer screening, and we talked about two different topics.
The first topic was what became colon Guard, a different
(01:54):
way to screen for colon cancer, one that was effective
and you could do the privacy of your own home.
The second topic was the idea of screening a whole
person from cancer from a single blood draw. That was
sixteen years ago, and much has changed during that time.
It's been a great journey.
Speaker 1 (02:12):
What are some of the key milestones in that journey.
I mean, we've got the coal Guard launch, We've got
some acquisitions. You know, when you think about the high points,
what are they in your mind.
Speaker 2 (02:21):
Well, I think the first four years was all about
developing an incredible test. It was product development, clinical trial,
raising enough capital to do both of those things. And
then one of the great milestones was the day we
got the results of what was called the deep Sea Study.
And another great day was FDA approval and launching coal
(02:44):
Guard and getting Medicare coverage on the same day as
we got FDA approval. So that was the first part
of the company, and that kind of springboarded us into
this whole different realm where we've grown as a company
and expanded our portfolio.
Speaker 1 (03:01):
You know, I was going through some of the old
transcripts and I actually went through the first Earnie's call
that you did, and you had a very ironic quote there.
You were asked about blood based screening test and I'm
paraphrasing here, but you mentioned that doctor Bert Vogelstein, and
he's a preeminent researcher at Hopkins for those that don't
know in this space, and I guess he said to
you something like I don't think it will ever be
(03:23):
achieved or ever work. And now here we are today,
you guys are watching this multi cancer early detection test.
Speaker 2 (03:29):
I mean are you.
Speaker 1 (03:30):
Surprised by this journey and the fact that the science
has come so far or did you see that light
at the end of the tunnel all the way back then?
Speaker 2 (03:36):
Well, a lot has changed and some things haven't changed.
So that conversation was in particular about a colon cancer
screening test. And I remember going into Bert's office, who's
a dear friend, and after Sigmund Freud, is the second
most published scientific researcher.
Speaker 1 (03:52):
Well, I never knew that.
Speaker 2 (03:53):
Yeah, and he's just an amazing person. But I went
into his office. I said, hey, Bert, you know idea
have a stool test. That's not really I would think
the direction we're going to go. We're thinking maybe a
blood test would be better. And he said, you obviously
didn't read my paper. And he said, Kevin, there's a
biological barrier here for detecting pre cancerous polyps and early cancers.
(04:16):
I see, And something has changed there. Yeah, sixteen years later,
not much has changed in that realm. What has changed
is that now the scientific proof that you can screen
a person for cancer from blood, not a perfect test,
but at a patient level and a population level. And
over time, we think you're going to shift detection to
(04:38):
an earlier, more treatable stage.
Speaker 1 (04:40):
Incredible, So that's a good Sakeway's let's talk about Cancer Guard.
You guys are watching it this week, you know, why
don't you give us the high points on the test
and where it kind of fits in the screening paradigm.
Speaker 2 (04:50):
The high point of cancer Guard it's one blood draw
to we think at least fifty different types and subtypes
of cancer. And the ideas to screen a person and
find cancers earlier than you would if you just waited
until the patient became symptomatic. Because the vast majority of
cancers have no screening test, and it's eighty six percent
(05:14):
of cancers are not found through screening. So the idea
is to screen the whole person. We've run a bunch
of different studies. A large case control study showed the
ability to detect the six deadliest cancers sixty eight percent sensitivity.
Now that probably won't be replicated in prospective studies. The
(05:38):
sensitivity or detection level will be less than that. It's
still the ideas to get tested on a regular basis,
so the odds increase significantly that you'll find a cancer earlier.
Speaker 1 (05:51):
And then what's the specificity of the test.
Speaker 2 (05:55):
So there's one of the great things about how we
have designed the test is to deliver a test with
a very low false positive rate. For cancer guard the
false positive rate is two point six percent. And to
put that in perspective, mammography has a thirteen percent false
(06:15):
positive rate. Okay, the PSA prosta specific nigen test over
twenty percent false positive rate, Lung cancers screening through low
dose CT over a twenty percent false positive rate. Even
colo guard plus, which we think is one of the
most accurate screening tests ever developed, is as a six
(06:38):
percent false positive rate. So we have designed the blood
test to have his low of a false positive rate.
And if you have a positive result, the idea is
go get a CT and pet at which answers the
question do you have cancer or not to a very
very to a kind of a ninety eight percent level
(06:58):
of satisfaction.
Speaker 1 (07:00):
So I guess, is there a support system kind of
put in place? So if a patient does get a
positive result that day and the who gets informed first,
is the clinician get informed first or does the patient
get informed at the same time.
Speaker 2 (07:12):
Yes, you want to inform the clinician first so they
can have the conversation with the patient, and then we
have a wealth of resources for patient or a physician
to reach out and have their questions answered. So they
have we have clinicians who will help guide the patient
through that next step in the journey.
Speaker 1 (07:31):
Got it. So you guys released your price point. I
guess the list price of six hundred and eighty nine dollars.
There's a competitor out there, Grails Gallery, which I think
wasts for nine forty nine. How did you arrive at
that six' eighty nine price?
Speaker 2 (07:45):
Point we interviewed patients and talked to them and listen to,
them and at what price point are you willing to
get a screening test with these performance? Characteristics and so
we decided with the out looking at, competition we looked at, saying,
okay how can we get the most people access to this.
(08:06):
Technology if you want to screen a, population you need.
Access and so the idea that an individual can pay
out of pocket or out of their flexible spending account
or their health savings, account that's at the six to
eighty nine price, point you saw an inflection up of
the percentage of people willing to get.
Speaker 1 (08:28):
Screened got? It and THEN i guess Maybe i'm an,
analyst SO i have to ask the, question you, know
what does the margin profile? Look you, know when you
kind of reach a steady, STATE i, guess.
Speaker 2 (08:38):
Well the goal always is to have a significant enough
margin so that you can constantly reinvest in research and.
Development so it'll be pretty similar to Colo guard over
time that the goal is a seventy plus percent gross margin,
again so that you can turn around and invest in
improvements and future clinical trials and make sure that you
(09:02):
can get a return on this significant investment made.
Speaker 1 (09:05):
Right, so you, know thinking about, that you know you
have a large commercial. Infrastructure how do you leverage, that
you know with this new.
Speaker 2 (09:12):
Test you, know that's one of the unique things we
have built At exact with Coal. Guard when we first thought, about,
okay how are we going to bring Coal guard to
patients and, physicians the logical explanation, will let's do it
through the large labs that exist in The United, States.
Speaker 1 (09:32):
So the, quests the lab, corps those sorts of.
Speaker 2 (09:33):
Folks, yes but we went and talked to those labs
and the response, was, look we're not great at promoting one.
Test we carry four thousand tests and just for a
number of. Reasons we, decided, well let's go build our
own commercial organization through our own. Lab but some of
the research said that was, very very difficult because you
(09:54):
have to build a commercial organization for primary care and
they are about seven hundred thousand active primary care healthcare
providers in THE. Us the math we started with eighty
sales for the first two, years we had eighty sales.
Speaker 1 (10:08):
Reps you just can't that's are pretty big. Territory so
those are pretty big.
Speaker 2 (10:12):
Territories so we you, know we did what we could,
do and over time we built an organization now that
is about one thousand, strong, Okay and what do they
do every single? Day they educate, physicians nurse, practitioners physician,
assistants office, staff medical. Administrators how does the test, work
(10:34):
how does the workflow? Work how frequently is it recommended
that a person be tested with? Couldgarden, now because we
have built this commercial, infrastructure a team of educators is
the WAY i like to think about. It and then
also we have built we have invested over a billion
dollars into building a tech platform that allows physicians to
(10:55):
easily order a, test get result for a. Test and
then also this often reminder, system, texts, emails phone, calls,
postcards that reminds. People there's almost a million touches a
day today really with our, customers a million a day
reminders prompts to, hey, look you, know, complete complete the.
(11:19):
Test it's a powerful. Engine and that engine applies now
to portfolio tests like Cancer.
Speaker 1 (11:24):
Guard got it here skipping ahead on my outline to
the exact. Nexus so we'll come back to that in a,
second BECAUSE i do have some other follow up questions,
there but staying on Cancer, guard you, know what does
a win look like for you guys in terms of
AND i don't know what the RIGHT kpi. Is is it?
Revenue is it the number of? Tests but where do
you want to be in five? Years AND i guess
(11:45):
you know the coroary to. That As grail has been
on the market for about five. Years its consensus thinks
it's about one hundred and forty three million in revenue this.
YEAR i, mean do you think you'll be ahead of
that in five?
Speaker 2 (11:55):
Years, well we have just an enormous reach to. Customers
we have reached two hundred and fifty thousand healthcare providers
Order colguard every, year and so it's think of Cancer
guard from the makers Of cologuard and through that trusted.
Brand it has taken us eleven years to build a
(12:16):
brand that has ninety five percent awareness and to build
this large trusted group of, educators and now that same
team will be educating starting this, week we have about
two hundred of the thousand that are trained on Cancer
guard and By january first one thousand. People so, yeah
we certainly hope to and expect to have massive reach
(12:41):
five years from. Now got to be disappointed if we
didn't have a couple of million people being. Tested and
we also have global, reach so we. Will we will reach.
Globally and you, Know grail has done an incredible job
really of innovating in this, field doing clinical trials and
doing it the right way with research and. Science that
(13:07):
together with the work that we've, done we think builds
the case for multi cancer.
Speaker 1 (13:13):
Screening that's a good segue to my next, question because
you have The Falcon, study can you talk about that
and when we might expect a readout at some.
Speaker 2 (13:20):
Point, yes The falcon study is a study of twenty
five thousand patients out there that are getting the Cancer guard,
test and it's a real world evidence study to, See,
okay what are the what is the success of the,
test what is the yield of cancers that we? Find
how many different types of cancers do we? Find how
(13:41):
does that compare to standard of care. Screening just a
wealth of data that will be used to submit FOR fda.
Approval where we have another study in the works called
SORE sar and that, study coupled with The falcon, study
will be us is to submit to F day. Approval
(14:02):
the timing we expect The falcon study to wrap up
in the next year or two and we're excited to
see the readout of.
Speaker 1 (14:09):
It so from a progression, standpoint you once you get
a submission TO, fda then you can Get medicare. Coverage.
Speaker 2 (14:17):
Correct this is the challenge.
Speaker 1 (14:19):
And i'm wondering about the roadmap to when do we
actually get these covered by.
Speaker 2 (14:24):
Insurance you, know The Medicare act allows and it's, ironic
it Allows medicare to pay for things for people when they're, sick,
devices drugs, diagnosed it if you're, healthy, though it doesn't
Allow medicare to pay for. That so a screening test
(14:45):
needs to get a specific congressional a law passed By
congress to approve screening for that particular organ or in this,
case for multiple types of. Cancer and so we've collaborated
with The American Care Answer, society many other cancer advocacy, ORGANIZATIONS,
grail and others who are banding together to Convince congress
(15:12):
to pass a. Law and the beautiful thing right now
is we have about three hundred and fifty co sponsors In,
congress equal number Of republicans And democrats who support this.
Legislation and our hope is that this legislation gets passed
and signed it into law this. Year this. Year, wow
that's the. Goal that's. Great we came very close last,
(15:34):
year very very very, close and so there's a lot
of momentum behind.
Speaker 1 (15:39):
This that's. Great so maybe just switching, gears we'll go
back to The nexus. Platform what sort of investment did
you have to make over the number OF i don't
know how many numbers of years it took you to build.
Speaker 2 (15:49):
It we started building the Exact nexus platform a year
before we Launched cologuards twelve years. Ago and this is
a technology platform that makes it easy to order a,
test get a result for a, test bill for a,
test all of the.
Speaker 1 (16:06):
Things reporting, everything, billing everyone messaging a.
Speaker 2 (16:09):
Patient it's there are about two hundred. Apps and then
also THE epic software as a basis of a platform
that allows us to do seemingly magical things in terms of,
connectivity WHICH i think is going to even get more
interesting with the power OF ai that is being applied
(16:30):
to THE epic data. Lake so that this platform we've
probably invested close to two billion dollars into helping to automate.
Screening that's how this year we expect to screen about
in the neighborhood of five Hundred i'm, sorry five million
(16:51):
people for colon, cancer which is pretty close to the
number of screening kolonoscopies performed in THE us every.
Speaker 1 (16:58):
Year, wow that's a fantastic. Statistic you MENTIONED, Epic but
are you integrated into some of the other workflows that
are out, there AND i, Mean i'm thinking about ambulatory,
EHRs whether IT'S cerna or athena and then maybe more,
specifically as you kind of move into the further into
the complexity of, oncology you, know things like flat iron
(17:19):
OR i KNOW. Med if you're A us oncology are
you integrated there as?
Speaker 2 (17:22):
Well, Yeah so on the primary care, side we're integrated
with most of those DIFFERENT emr. Systems you have to
do work, though in every large health system to make
sure that that integration is clean and. Tight and so
that we have about four hundred and fifty health systems
(17:42):
in THE us that we're integrated. With that means that
represents seven hundred thousand healthcare providers who can order our tests,
electronically and that's a pretty powerful capability because otherwise everything
is done by.
Speaker 1 (17:58):
Facts, still we have this conversation with this podcast all
the time about faxes are the only the healthcare industry
is the only ones keeping the fact companies in businesses.
Speaker 2 (18:08):
Anymore it's amazing the power of that platform and the
how standard it has become to connect with Exact nexus
will help fuel the growth of Cancer. Guard and it's.
Taken it's taken twelve. Years there's no shortcut to.
Speaker 1 (18:25):
It so you mentioned building, it you, know initially for Coal,
guard AND i think that's a good transition to Cold guard.
Plus can we talk a little bit, about you, know
what the newer version helps catalyze relative to the older.
Speaker 2 (18:38):
Version the goal with Cold guard plus was let's reinvent
the test with all new biomarkers to improve both the,
sensitivity so the percentage of cancers that you find pre
cancers that you, find and while lowering the false positive.
Rate that's a really hard thing to. Do and, logically
(19:00):
what you're trying to do is you're trying to find
CANCER dna and cancer is basically a disease of THE,
Dna so find the tiny little changes that occur in
the cancer cells that are being sloughed off being into the.
Stool and it's a hard thing to. Do but what
coldguard plus the problem it solved was a false positive
(19:23):
rate of ten, Percent, okay still lower than a, mammogram
but every one of those patients have to go to a.
Colonoscopy so our goal was to reduce the false positive
rate by thirty. Percent we ended up having showing data
that we reduce the false positive rate by forty. Percent
so now only six percent of people with a what
(19:43):
we would call it clean colon No precancero's, polyps no.
Polyps among that, population there are only six percent that
have a false positive got.
Speaker 1 (19:54):
It and do the unit economics for the test change
with this newer, version.
Speaker 2 (19:58):
The unit economic improve by five to ten. Percent that's,
great and that is another nice feature of the test
is we simplified the workflow in our lab and that
allows us greater capacity and lower cost per.
Speaker 1 (20:15):
Tests when you say simplify the, workflow is it just less?
Steps is it? Automation is less human? TOUCHES i know
that's a big part of. It always as, well.
Speaker 2 (20:24):
All of that more, Automation but there's instead of having
ten bio, markers there are three main bio markers in the.
Speaker 1 (20:31):
Test that makes. Sense you, know as you think about
the growth of algorithm long, term what's going to drive
the growth of Could guard going.
Speaker 2 (20:39):
Forward the, brand the, awareness the accessibility of the, test
and our commercial organization educating every. Week every single, week
we have eight hundred new healthcare providers that Order coliguard
for the first. Time and what you want to do
is full educate those healthcare providers and your current customer
(21:03):
base of about two hundred thousand healthcare providers that order
Coal guard every. Quarter educate them about the, science the clinical,
evidence and also all of the workflow and reminders and
the importance of rescreening patients every three. Years that is
(21:23):
shown to increase. Adoption and, look there fifty million people
out there in THE us that are not up to
date with col cancer. Screening the reach that we have
with digital and social is becoming more sophisticated that messaging
that we, have and so you want more than, awareness
you want to then drive somebody to action to take
(21:45):
control of their own. Health and we're doing that and
we're at a period of real. Inflection there was eighteen
percent growth last, quarter and that's eighteen percent growth off
a big. Base so we're really proud of what the
team is doing to make colon cancer screening. Inevitable got?
Speaker 1 (22:07):
It within the patient, population you HAVE i guess new
patients and then you have. Rescreens what does that split
look like from a percentage basis or a total number of.
Speaker 2 (22:15):
Tests it's about in the neighborhood plus or minus of
thirty percent of the volumes today are rescreened. Patients and
if you kind of look at it in, totality there
have been a right around twenty two million total tests
and about approaching eighteen million unique. Individuals but this is
building over time because the ramp has been so. Steep
(22:36):
the bulk of the people who have been screening have
been screening in the last few, years and since it's
an every three year. Test what you're seeing is a
rapid increase in the eligible population, too that is eligible for.
Rescreen last year there were one point six million people
eligible for. Rescreen this year it's two. Million next year
it's two point six. Million so that's building over. Time,
(22:59):
Yes and what is the adherence of those? Rescreens is?
It it's incredible if for a second time user it's eighty.
Percent For, wow a third time user it's ninety, percent
and h for a fourth time user it's ninety five.
Percent fourth time. User were they in the original cohort in?
Thousand the original cohort one of THOSE i would. Hope so.
Speaker 1 (23:27):
Moving, move maybe just switching gears because we've been spending
a lot of time on the screening. Portfolio if we
switch over to the precision, oncology you've had some good
news there with anco. Detect you, know there's a lot of.
Stuff we'll get to the blood based correctal cancer, screening
but maybe let's start with onco. Detect how do you
see this market unfolding in minimum residual disease testing OR mrd.
(23:49):
TESTING i, mean there's increasingly a whole lot of players
looking at the same.
Speaker 2 (23:53):
Space there are and our story goes back to twenty
nineteen WHEN i my Friend Kim Popo bits and we
had a conversation about bringing exact sciences And Genomic. Health
kim WAS ceo Of Genomic. Health together as one powerful,
Company Genoma health had reached has reached to about ninety
(24:18):
percent of oncologists in THE us through anchotype D, x
which is a test that has transformed guiding treatment for
breast cancer. Patients so our view WITH mrd is, that
first of, all we think it's going to transform the
way that people are treated with. Cancer and being able
(24:40):
to detect recurrence of cancer up to a year before
you could see it on A pet, scan that's. Powerful
and how does that change the way that you potentially
increase the treatment or decrease the treatment if a patient
is negative for several. Years and IF i can just
for a, MINUTE i have a friend who is diagnosed
(25:01):
with kidney, cancer with stage four kidney. Cancer sorry to hear. That,
well the incredible thing is after being on k, truda
have a NEGATIVE mrd tests for three or four year
period of, time she's been able to go off k
trudah in pet, scans MR d test is negative and
HER pet scans. Negative so now she's able to go
(25:24):
off k truda and she's healthy and, happy and it's
a powerful story that gives a clinician confidence to make
a treatment. Decision so where is kind of our entry
point into this, field knowing that this is not a
field that we, created it's the strength of the fact
that we see about fifty percent of all breast cancer
(25:47):
tissues in Our Jenoma health lab, Our Redwood City Exact sciences.
Lab we see that samples from patients in ninety nine
countries around the, world so we have a global. Reach
we have the starting. Point many, oncologists most community on
collogists treat more than breast. Cancer they treat patients with
(26:10):
all different types of, cancer so we can expand from.
There we also have strength in colon cancer because Of
colon guard and so that's actually our First medicare coverage
is in colon. Cancer so we'll be able to expand from.
There AND i don't think that we'll be in third
place in this. Field that's under.
Speaker 1 (26:28):
Sure so do you have The medicare coverage decision and
Correctal it sounds like you're going to pursue the other.
Cancers do you go AFTER adlt for this at some
point likely is that helpful to the, profile the financial,
profile or does it make it more difficult for some
reason that MAYBE i don't.
Speaker 2 (26:48):
UNDERSTAND adlt is the is the pricing mechanism that there
are two ways to pick pricing mechanism that allows you
to choose your price for the first nine months or,
so and that is one is having something new and.
Innovative the other is GETTING fda. Approval, Right so we
(27:09):
would pursue this, path most likely with THE fda, approval
which would allow us to then have A dlt. Pricing
but we have pricing today and we're happy with the
launch that is that we launched On Goo detect earlier this,
year and now we're we're bringing it to the physicians
(27:29):
and patients that we serve already with our precision oncology.
Business got?
Speaker 1 (27:34):
It how does that market unfold from a clinician, perspective
BECAUSE i Imagine i'm a community, oncologist and there's, yourselves there's your,
competitors maybe they're all coming. IN i, Mean i've got
a pharmaceutical, background SO i always think of, detailing even
THOUGH i don't think that happens in the same way
anymore like it did twenty years. Ago but how DO
i how DO i make that decision as a clinician
(27:56):
which TEST i want to use or is it being
made for me maybe by my.
Speaker 2 (28:00):
Network, well we're PRETTY. Gpo we're pretty early in the
development of this whole. Field, okay maybe maybe ten percent
of patients who should be getting tested WITH mrd are being.
Tested and so there's going to be a lot of
(28:21):
changes that occur over the next five. Years what are
clinicians looking. For they're looking for, Accuracy they're looking for
ease of, Use they're looking for a trusted. Source and,
increasingly as we have conversations with health, systems they want
to work with one advanced cancer diagnostic company or, two not.
(28:43):
Twelve and SO i think that's one of the opportunities
that we have is to continue to serve these same health.
Systems and that's where having the technology to make electronic
ordering and resulting in billing and prior authorization and reminders
and all of that, seamless that's where we think we
(29:04):
can serve those pay those, customers those large organized health
systems on colleges very. Well then also, quality one of
the wonderful things about ARCHETYPE dx is just it denotes,
quality and onco detect OUR mrd test is we believe
also will denote that same level of.
Speaker 1 (29:24):
Quality, No well, SAID i you, know you AND i
kind of live in this, world AND i think we
think everybody's getting these. Tests, maybe but the reality is
it still is very. Nascent my mother in law had
colon cancer a couple of years, ago and she had
surgery to resect her col and then she's. Fine and
at the TIME i, suggested maybe you should ask your
oncologists About at the, time really signatara was the only,
(29:45):
option and she did ask him and he, said, Well
i'm not really sure What i'm going to do if
it comes back. Positive AND i think that was a
hurdle to. Adoption and now the workflow has changed so
much and the clinicians are so used to actually maybe
ordering these tests that it's becoming a lot more of
the standard of.
Speaker 2 (30:02):
Care it. Is AND i mean that story is a typical.
Story what would you do with a positive? Result you'd
probably treat more, aggressively because if you look at the
data that has been generated in, studies it shows that
a positive result is thirty to fifty times more likely
to recur than a negative. Result so now that oncologists can, Say,
(30:26):
okay what's the full scope of treatment that should, occur
and maybe how often should we be doing pet scans
to look for small metastasis that we could Deal.
Speaker 1 (30:38):
That was actually the key DETAIL i left. Out his
reticence was around what IF i get a positive test
but the imaging is. Negative, yeah BUT i think there's
more comfort now that the positive from the tests is
a true.
Speaker 2 (30:50):
Positive it is there any other test that has as
high of a positive predictive value as that N mr
detail that a positive fifty is thirty to fifty times
more likely to recur than. Not, well that's added in
information that a patient needs to know and an oncologist
(31:13):
needs to. Know, so, yes the level of evidence that
has been Created Sotara natara has done great work in
this field to help unlock value, here AND i think
it's going to change everything in THE us and globally
about how cancer is. Treated lots of things will change
That we're still very early in the.
Speaker 1 (31:33):
Journey do you think these will now are soon become
part of guidelines AND ccn guidelines at some.
Speaker 2 (31:38):
Point that's the hope that it happens. SOON i think
it's inevitable that it does. Happen the question is when
more evidence accrues and, develops and then, again what is
the evidence about what is the next best thing to
do once you have a positive. Result so that's the
next kind of types of studies that are being run right.
Speaker 1 (32:00):
Now, yeah there's a lot of interesting stuff happening in this.
Field so we'll switch gears again and let's go TO
i think where the area debate is most recently in exact,
sciences at least from an investor, perspective is around the
corectal blood. Test you, know you guys Bought thrive a
number of years, Ago you've been developing your own internal,
tests and Now i've signed this deal with Free. Noome
(32:22):
can you just walk me through the think the thought,
process so you know why a partnership and a royalty
deal versus maybe like an outright.
Speaker 2 (32:31):
Acquisition so let's taking a step back and looking at
what is the right test for a. Patient is it,
colonoscopy is it colon? Guard is it a fit test
or is it a BLOOD dna? Test and the evidence
is pretty clear here that colo guard and colonoscopy are
the two most effective, tests meaning that they're the best
(32:55):
at detecting pre cancer's polyps and stage one, cancer the
cancers that are ninety eight percent. Treatable blood tests struggle
to detect those two. Things so some of the guidelines
that are evolving are, Saying, okay a blood test could
be should be used for patients who refuse one of
(33:17):
the higher quality tests colo garder of, colonoscopy and we
think that that is probably the way this market, evolves
that for people who are true, refusers a blood test
is better than no test at.
Speaker 1 (33:33):
All what do you think that number is from a
percentage base at all eligible folks who are eligible for a.
Speaker 2 (33:39):
COLONOSCOPY i think that because of the strength of the
colonoscopy as a, brand col Of guard as a, brand
you're going to see over time maybe only five to
ten percent of people who.
Speaker 1 (33:52):
Opt for the blood based test.
Speaker 2 (33:54):
Or a blood. Test and even, then you, know once
they start getting, screened maybe they will be educated that
there's much more accurate way to be. Screened either colonoscopy
or colal guard would be the approaches that the guideline.
FOLKS i think point, two you, know but it's important
to have an option and that was our thinking with
(34:15):
acquiring the exclusive rights to the test That freedome. Developed
We freedome has its own vision as a company and
that goes beyond their colon cancer blood, tests and our
goal was to, say, okay this is a test that
we can serve patients with who refuse a coal guard
(34:37):
test and at least get them. Screened and so our
thought process of licensing the test was that was the
more economically efficient way for us to bring that test to.
Patients and SO i think we have a very strong
partnership now given our capabilities of reaching. Patients it's with
(35:00):
the thousand people in the field and all of the
technology and relationships with large health.
Speaker 1 (35:06):
Systems that makes sense that the rationale is, that, well
it's not the best. Option maybe for, patients it'll be
for lack of a better, term in your, bag, yes
and they will be coming to exact if they don't
go one of those other.
Speaker 2 (35:17):
Routes, well we know that we have seen over thirty
million colo guard test orders and just over twenty, million
twenty two million completed, Tests so there's ten million people
out there that didn't complete a cold guard. Test you
have similar numbers for people who didn't show up for.
Colonoscopies so is there are a way for us to
(35:40):
get them a kit that they would just take into
a quest blood draw site and have their blood. Drawn,
yeah there, is and we have the ability to get
those the right patients and this is the appropriate unique
patients and to get their blood. Drawn got.
Speaker 1 (35:58):
It we're recording this at the beginning Of, september and
you just had to, appear you, know come out with
THEIR v two results a week or two. Ago you,
know they didn't see a dramatic change in terms of
their their efficacy or a specificity or. Sensitivity you, know
are we Reached AND i don't want necessarily ask you
to comment on your peers, results but are we reaching
(36:19):
the limits of detection and the utility of these tests
in some? Ways is that a concern for? You, well,
scientifically we. Can't we can't get maybe much past where
where the current tests are at from a specificity and sensitivity.
Speaker 2 (36:33):
Level we talked about that earlier early CONVERSATION i had
With Bert vogelstein where he, Said, kevin, hey did you
read my? Paper and what does? Paper it basically showed
he COUNTED dna molecules in blood and that just exponentially
decreases with the stage of cancer and the size of
(36:54):
the pre cancerous. Polyp and they there are peers to
be a biological barrier as you would. Expect, look your
colon is designed to keep things out of your blood.
Supply nature has done a very good job at. That
if it, didn't we wouldn't. Exist so, yeah we probably
are reaching that limit at least WITH, dna but will
(37:17):
never stop. Looking is that some other class of marker.
Speaker 1 (37:22):
That whether it's methilation or protein or whatever it might.
Speaker 2 (37:25):
Be whatever it might, be whatever it might. Be and
we have a team in Our Advanced technology group that
that's what they do all day. Long we look at
other people's technology and our view, is, look some of
the best technologies are in the outside our four, walls
not inside our for. Walls so let's be a company
(37:46):
that is capable of bringing in new technology and bringing
into physicians and. Patients that's.
Speaker 1 (37:52):
Great we're getting towards the end of our time here
AND i want to ask you a couple questions on the.
Future and we've talked a little bit about the product road,
apps but you, know one of the great sides you
had in your investor dec as you showed the two
franchises and you started checking off the different products as
you brought them to. Market and you guys have done
a great job recently putting a lot of check marks
up there over the last year or. So and so
(38:15):
as you think about the organization and the heavy lifting
you've had to do to commercialize these, products you, know
what do you have to do now for the harvesting
phase over the next couple of. Years and if we
think about exact three to five whatever time frames appropriate
years from, now you know where do you want where
do you want the company to?
Speaker 2 (38:32):
Be our vision as a company is to help eradicate
cancer with tests that prevented detected earlier in guide. Treatment
what we have built over the last sixteen years is
just the starting point for achieving that. Vision colo guard
On kotype now this broad portfolio of eight to ten
(38:54):
different tests that help achieve that, vision and so we
have an excite five ten years ahead of us where
we're bringing those tests all to the patients and physicians
who need, Them educating, physicians educating, patients running the clinical
trials that create the stickiness with, payers so to increase
(39:16):
their willingness to pay for these, tests educating policy makers
to make sure that our Cancer guard test is widely
available with zero out of pocket Like Colo. Guards so
it's an exciting and fun time to be At Exact.
Sciences there's great, science there's great commercial, efforts and THEN
(39:40):
i think the other thing is making the digital connectivity
with our customers just the best in the. World and
that has been a really fun part of the. JOURNEY
i can't wait for some of these portfolio tests to
start to have an, impact and this year it was
three test, Launches Cold guard, plus Onco detect and Now Cancer.
(40:04):
Guard the team's.
Speaker 1 (40:05):
Busy, well maybe as a corre woray to, that you,
know how are you spending your time differently than maybe
you have in the, Past and as you think about
maybe the year, ahead do you think there's going to
be are you be doing anything different from a day
to day?
Speaker 2 (40:17):
Perspective you, know my days have changed constantly every. YEAR
i felt LIKE i needed to reinvent myself as a,
leader and how you spend your time defines how you.
Lead who do you spend your time, with what do
(40:38):
you spend your time on AND i would say spending
time on company culture is critically. Important spending your time
on science and innovation is critically. Important probably diminishing the
time THAT i spend with investors and letting those results
and teams that work on those things that allows me
(40:58):
to spend more time on the global opportunity with bringing
our tests to the physicians and patients who can benefit
outside THE.
Speaker 1 (41:07):
Us that's well. Said we'll have to do this again
in a couple of years and see where you are
on a global. Basis thank, You.
Speaker 2 (41:14):
Jonathan you know we're so proud of the work that
the team has. Done it's, painstaking nothing happens. Quickly it's,
science it's robust clinical, trials and ultimately you wake up
every day knowing now we're making a tangible impact on
the lives of. Others and if you want to be
(41:34):
part of, That Exact sciences is a wonderful place to
spend your. CAREER i lost my mother this last, week
so sorry to hear. That and she was a nurse
for forty years and a nursing instructor and a. Leader
she helped run a hospital In, Flint. Michigan and one
(41:57):
of the beautiful things that she always kind of reminded
me about my siblings about was it's about other people
and how can you care for them and how can
you make their lives? Better and so for, me it
has been a personal joy to be able to work
for the last sixteen years on helping people improve their
(42:20):
life in a really basic and meaningful, way whether it's
screening somebody and giving them the comfort that they're they
don't have, cancer or whether it is helping to find
a cancer. Earlier it's it's a wonderful place to spend
your life's.
Speaker 1 (42:40):
Work it sure. Is you, know you must have read
my mind BECAUSE i typically ask a very formal question
about you, know what's the mission that drives you on
a day to day AND i think you answered it
in your last. Comments And i'm so sorry for your family's,
loss and thank you for sharing. That this has been
a fantastic, Discussion, kevin thank, You, jonathan and with that
(43:00):
we'll wrap. Up That's Kevin, conroy THE ceo Of Exact.
Sciences thank you so much for joining us on our latest,
episode and please make sure to quick the follow button
on your favorite podcast app or site so you've 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 Bloomberger. Intelligence until next, time take. Care those
(44:01):
are
Welcome to another episode of Boomberg Intelligences Vanguards of Healthcare podcasts,
where we speak 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. I'm thrilled to welcome today's guest,
Kevin Conroy, the chairman and chief executive officer of Exact Sciences.
Exact is a leader in cancer diagnostics, and our listeners
(00:38):
will know it from its flagship coal of Guard screening
test for coorectal cancer, which generates more than two billion
in annual revenue. But Exact is more than just COLO Guard.
There's ancotype DX, risk Guard, onco Detect, onco Extra, and
just this week they've announced the launch of Cancer Guard,
the company's entree into the multi cancer early detection space.
Welcome to the podcast, Kevin.
Speaker 2 (00:59):
Thank you, Jonathan. It's great to be here.
Speaker 1 (01:02):
So before we dive into the present day and there's
a lot going on, I just wanted to maybe start
with the remarkable journey that you've you know, shepherded the
company through. It's really a profound transformation a lot of
folks might not really remember this, but Exact's first stool
cancer stool based cancer test, Pregen plus, you know, was
discontinued in two thousand and eight, and then you came
(01:22):
on in two thousand and nine. So maybe from a
high level, can you walk us through the evolution of
the company from when you first came on all those
years ago.
Speaker 2 (01:31):
Yeah. I joined after a meeting with doctor David Alquist
at the Mail Clinic. And Dave was a pre eminent researcher,
clinician many times funded by NIH and NCI, and his
passion was cancer screening, and we talked about two different topics.
The first topic was what became colon Guard, a different
(01:54):
way to screen for colon cancer, one that was effective
and you could do the privacy of your own home.
The second topic was the idea of screening a whole
person from cancer from a single blood draw. That was
sixteen years ago, and much has changed during that time.
It's been a great journey.
Speaker 1 (02:12):
What are some of the key milestones in that journey.
I mean, we've got the coal Guard launch, We've got
some acquisitions. You know, when you think about the high points,
what are they in your mind.
Speaker 2 (02:21):
Well, I think the first four years was all about
developing an incredible test. It was product development, clinical trial,
raising enough capital to do both of those things. And
then one of the great milestones was the day we
got the results of what was called the deep Sea Study.
And another great day was FDA approval and launching coal
(02:44):
Guard and getting Medicare coverage on the same day as
we got FDA approval. So that was the first part
of the company, and that kind of springboarded us into
this whole different realm where we've grown as a company
and expanded our portfolio.
Speaker 1 (03:01):
You know, I was going through some of the old
transcripts and I actually went through the first Earnie's call
that you did, and you had a very ironic quote there.
You were asked about blood based screening test and I'm
paraphrasing here, but you mentioned that doctor Bert Vogelstein, and
he's a preeminent researcher at Hopkins for those that don't
know in this space, and I guess he said to
you something like I don't think it will ever be
(03:23):
achieved or ever work. And now here we are today,
you guys are watching this multi cancer early detection test.
Speaker 2 (03:29):
I mean are you.
Speaker 1 (03:30):
Surprised by this journey and the fact that the science
has come so far or did you see that light
at the end of the tunnel all the way back then?
Speaker 2 (03:36):
Well, a lot has changed and some things haven't changed.
So that conversation was in particular about a colon cancer
screening test. And I remember going into Bert's office, who's
a dear friend, and after Sigmund Freud, is the second
most published scientific researcher.
Speaker 1 (03:52):
Well, I never knew that.
Speaker 2 (03:53):
Yeah, and he's just an amazing person. But I went
into his office. I said, hey, Bert, you know idea
have a stool test. That's not really I would think
the direction we're going to go. We're thinking maybe a
blood test would be better. And he said, you obviously
didn't read my paper. And he said, Kevin, there's a
biological barrier here for detecting pre cancerous polyps and early cancers.
(04:16):
I see, And something has changed there. Yeah, sixteen years later,
not much has changed in that realm. What has changed
is that now the scientific proof that you can screen
a person for cancer from blood, not a perfect test,
but at a patient level and a population level. And
over time, we think you're going to shift detection to
(04:38):
an earlier, more treatable stage.
Speaker 1 (04:40):
Incredible, So that's a good Sakeway's let's talk about Cancer Guard.
You guys are watching it this week, you know, why
don't you give us the high points on the test
and where it kind of fits in the screening paradigm.
Speaker 2 (04:50):
The high point of cancer Guard it's one blood draw
to we think at least fifty different types and subtypes
of cancer. And the ideas to screen a person and
find cancers earlier than you would if you just waited
until the patient became symptomatic. Because the vast majority of
cancers have no screening test, and it's eighty six percent
(05:14):
of cancers are not found through screening. So the idea
is to screen the whole person. We've run a bunch
of different studies. A large case control study showed the
ability to detect the six deadliest cancers sixty eight percent sensitivity.
Now that probably won't be replicated in prospective studies. The
(05:38):
sensitivity or detection level will be less than that. It's
still the ideas to get tested on a regular basis,
so the odds increase significantly that you'll find a cancer earlier.
Speaker 1 (05:51):
And then what's the specificity of the test.
Speaker 2 (05:55):
So there's one of the great things about how we
have designed the test is to deliver a test with
a very low false positive rate. For cancer guard the
false positive rate is two point six percent. And to
put that in perspective, mammography has a thirteen percent false
(06:15):
positive rate. Okay, the PSA prosta specific nigen test over
twenty percent false positive rate, Lung cancers screening through low
dose CT over a twenty percent false positive rate. Even
colo guard plus, which we think is one of the
most accurate screening tests ever developed, is as a six
(06:38):
percent false positive rate. So we have designed the blood
test to have his low of a false positive rate.
And if you have a positive result, the idea is
go get a CT and pet at which answers the
question do you have cancer or not to a very
very to a kind of a ninety eight percent level
(06:58):
of satisfaction.
Speaker 1 (07:00):
So I guess, is there a support system kind of
put in place? So if a patient does get a
positive result that day and the who gets informed first,
is the clinician get informed first or does the patient
get informed at the same time.
Speaker 2 (07:12):
Yes, you want to inform the clinician first so they
can have the conversation with the patient, and then we
have a wealth of resources for patient or a physician
to reach out and have their questions answered. So they
have we have clinicians who will help guide the patient
through that next step in the journey.
Speaker 1 (07:31):
Got it. So you guys released your price point. I
guess the list price of six hundred and eighty nine dollars.
There's a competitor out there, Grails Gallery, which I think
wasts for nine forty nine. How did you arrive at
that six' eighty nine price?
Speaker 2 (07:45):
Point we interviewed patients and talked to them and listen to,
them and at what price point are you willing to
get a screening test with these performance? Characteristics and so
we decided with the out looking at, competition we looked at, saying,
okay how can we get the most people access to this.
(08:06):
Technology if you want to screen a, population you need.
Access and so the idea that an individual can pay
out of pocket or out of their flexible spending account
or their health savings, account that's at the six to
eighty nine price, point you saw an inflection up of
the percentage of people willing to get.
Speaker 1 (08:28):
Screened got? It and THEN i guess Maybe i'm an,
analyst SO i have to ask the, question you, know
what does the margin profile? Look you, know when you
kind of reach a steady, STATE i, guess.
Speaker 2 (08:38):
Well the goal always is to have a significant enough
margin so that you can constantly reinvest in research and.
Development so it'll be pretty similar to Colo guard over
time that the goal is a seventy plus percent gross margin,
again so that you can turn around and invest in
improvements and future clinical trials and make sure that you
(09:02):
can get a return on this significant investment made.
Speaker 1 (09:05):
Right, so you, know thinking about, that you know you
have a large commercial. Infrastructure how do you leverage, that
you know with this new.
Speaker 2 (09:12):
Test you, know that's one of the unique things we
have built At exact with Coal. Guard when we first thought, about,
okay how are we going to bring Coal guard to
patients and, physicians the logical explanation, will let's do it
through the large labs that exist in The United, States.
Speaker 1 (09:32):
So the, quests the lab, corps those sorts of.
Speaker 2 (09:33):
Folks, yes but we went and talked to those labs
and the response, was, look we're not great at promoting one.
Test we carry four thousand tests and just for a
number of. Reasons we, decided, well let's go build our
own commercial organization through our own. Lab but some of
the research said that was, very very difficult because you
(09:54):
have to build a commercial organization for primary care and
they are about seven hundred thousand active primary care healthcare
providers in THE. Us the math we started with eighty
sales for the first two, years we had eighty sales.
Speaker 1 (10:08):
Reps you just can't that's are pretty big. Territory so
those are pretty big.
Speaker 2 (10:12):
Territories so we you, know we did what we could,
do and over time we built an organization now that
is about one thousand, strong, Okay and what do they
do every single? Day they educate, physicians nurse, practitioners physician,
assistants office, staff medical. Administrators how does the test, work
(10:34):
how does the workflow? Work how frequently is it recommended
that a person be tested with? Couldgarden, now because we
have built this commercial, infrastructure a team of educators is
the WAY i like to think about. It and then
also we have built we have invested over a billion
dollars into building a tech platform that allows physicians to
(10:55):
easily order a, test get result for a. Test and
then also this often reminder, system, texts, emails phone, calls,
postcards that reminds. People there's almost a million touches a
day today really with our, customers a million a day
reminders prompts to, hey, look you, know, complete complete the.
(11:19):
Test it's a powerful. Engine and that engine applies now
to portfolio tests like Cancer.
Speaker 1 (11:24):
Guard got it here skipping ahead on my outline to
the exact. Nexus so we'll come back to that in a,
second BECAUSE i do have some other follow up questions,
there but staying on Cancer, guard you, know what does
a win look like for you guys in terms of
AND i don't know what the RIGHT kpi. Is is it?
Revenue is it the number of? Tests but where do
you want to be in five? Years AND i guess
(11:45):
you know the coroary to. That As grail has been
on the market for about five. Years its consensus thinks
it's about one hundred and forty three million in revenue this.
YEAR i, mean do you think you'll be ahead of
that in five?
Speaker 2 (11:55):
Years, well we have just an enormous reach to. Customers
we have reached two hundred and fifty thousand healthcare providers
Order colguard every, year and so it's think of Cancer
guard from the makers Of cologuard and through that trusted.
Brand it has taken us eleven years to build a
(12:16):
brand that has ninety five percent awareness and to build
this large trusted group of, educators and now that same
team will be educating starting this, week we have about
two hundred of the thousand that are trained on Cancer
guard and By january first one thousand. People so, yeah
we certainly hope to and expect to have massive reach
(12:41):
five years from. Now got to be disappointed if we
didn't have a couple of million people being. Tested and
we also have global, reach so we. Will we will reach.
Globally and you, Know grail has done an incredible job
really of innovating in this, field doing clinical trials and
doing it the right way with research and. Science that
(13:07):
together with the work that we've, done we think builds
the case for multi cancer.
Speaker 1 (13:13):
Screening that's a good segue to my next, question because
you have The Falcon, study can you talk about that
and when we might expect a readout at some.
Speaker 2 (13:20):
Point, yes The falcon study is a study of twenty
five thousand patients out there that are getting the Cancer guard,
test and it's a real world evidence study to, See,
okay what are the what is the success of the,
test what is the yield of cancers that we? Find
how many different types of cancers do we? Find how
(13:41):
does that compare to standard of care. Screening just a
wealth of data that will be used to submit FOR fda.
Approval where we have another study in the works called
SORE sar and that, study coupled with The falcon, study
will be us is to submit to F day. Approval
(14:02):
the timing we expect The falcon study to wrap up
in the next year or two and we're excited to
see the readout of.
Speaker 1 (14:09):
It so from a progression, standpoint you once you get
a submission TO, fda then you can Get medicare. Coverage.
Speaker 2 (14:17):
Correct this is the challenge.
Speaker 1 (14:19):
And i'm wondering about the roadmap to when do we
actually get these covered by.
Speaker 2 (14:24):
Insurance you, know The Medicare act allows and it's, ironic
it Allows medicare to pay for things for people when they're, sick,
devices drugs, diagnosed it if you're, healthy, though it doesn't
Allow medicare to pay for. That so a screening test
(14:45):
needs to get a specific congressional a law passed By
congress to approve screening for that particular organ or in this,
case for multiple types of. Cancer and so we've collaborated
with The American Care Answer, society many other cancer advocacy, ORGANIZATIONS,
grail and others who are banding together to Convince congress
(15:12):
to pass a. Law and the beautiful thing right now
is we have about three hundred and fifty co sponsors In,
congress equal number Of republicans And democrats who support this.
Legislation and our hope is that this legislation gets passed
and signed it into law this. Year this. Year, wow
that's the. Goal that's. Great we came very close last,
(15:34):
year very very very, close and so there's a lot
of momentum behind.
Speaker 1 (15:39):
This that's. Great so maybe just switching, gears we'll go
back to The nexus. Platform what sort of investment did
you have to make over the number OF i don't
know how many numbers of years it took you to build.
Speaker 2 (15:49):
It we started building the Exact nexus platform a year
before we Launched cologuards twelve years. Ago and this is
a technology platform that makes it easy to order a,
test get a result for a, test bill for a,
test all of the.
Speaker 1 (16:06):
Things reporting, everything, billing everyone messaging a.
Speaker 2 (16:09):
Patient it's there are about two hundred. Apps and then
also THE epic software as a basis of a platform
that allows us to do seemingly magical things in terms of,
connectivity WHICH i think is going to even get more
interesting with the power OF ai that is being applied
(16:30):
to THE epic data. Lake so that this platform we've
probably invested close to two billion dollars into helping to automate.
Screening that's how this year we expect to screen about
in the neighborhood of five Hundred i'm, sorry five million
(16:51):
people for colon, cancer which is pretty close to the
number of screening kolonoscopies performed in THE us every.
Speaker 1 (16:58):
Year, wow that's a fantastic. Statistic you MENTIONED, Epic but
are you integrated into some of the other workflows that
are out, there AND i, Mean i'm thinking about ambulatory,
EHRs whether IT'S cerna or athena and then maybe more,
specifically as you kind of move into the further into
the complexity of, oncology you, know things like flat iron
(17:19):
OR i KNOW. Med if you're A us oncology are
you integrated there as?
Speaker 2 (17:22):
Well, Yeah so on the primary care, side we're integrated
with most of those DIFFERENT emr. Systems you have to
do work, though in every large health system to make
sure that that integration is clean and. Tight and so
that we have about four hundred and fifty health systems
(17:42):
in THE us that we're integrated. With that means that
represents seven hundred thousand healthcare providers who can order our tests,
electronically and that's a pretty powerful capability because otherwise everything
is done by.
Speaker 1 (17:58):
Facts, still we have this conversation with this podcast all
the time about faxes are the only the healthcare industry
is the only ones keeping the fact companies in businesses.
Speaker 2 (18:08):
Anymore it's amazing the power of that platform and the
how standard it has become to connect with Exact nexus
will help fuel the growth of Cancer. Guard and it's.
Taken it's taken twelve. Years there's no shortcut to.
Speaker 1 (18:25):
It so you mentioned building, it you, know initially for Coal,
guard AND i think that's a good transition to Cold guard.
Plus can we talk a little bit, about you, know
what the newer version helps catalyze relative to the older.
Speaker 2 (18:38):
Version the goal with Cold guard plus was let's reinvent
the test with all new biomarkers to improve both the,
sensitivity so the percentage of cancers that you find pre
cancers that you, find and while lowering the false positive.
Rate that's a really hard thing to. Do and, logically
(19:00):
what you're trying to do is you're trying to find
CANCER dna and cancer is basically a disease of THE,
Dna so find the tiny little changes that occur in
the cancer cells that are being sloughed off being into the.
Stool and it's a hard thing to. Do but what
coldguard plus the problem it solved was a false positive
(19:23):
rate of ten, Percent, okay still lower than a, mammogram
but every one of those patients have to go to a.
Colonoscopy so our goal was to reduce the false positive
rate by thirty. Percent we ended up having showing data
that we reduce the false positive rate by forty. Percent
so now only six percent of people with a what
(19:43):
we would call it clean colon No precancero's, polyps no.
Polyps among that, population there are only six percent that
have a false positive got.
Speaker 1 (19:54):
It and do the unit economics for the test change
with this newer, version.
Speaker 2 (19:58):
The unit economic improve by five to ten. Percent that's,
great and that is another nice feature of the test
is we simplified the workflow in our lab and that
allows us greater capacity and lower cost per.
Speaker 1 (20:15):
Tests when you say simplify the, workflow is it just less?
Steps is it? Automation is less human? TOUCHES i know
that's a big part of. It always as, well.
Speaker 2 (20:24):
All of that more, Automation but there's instead of having
ten bio, markers there are three main bio markers in the.
Speaker 1 (20:31):
Test that makes. Sense you, know as you think about
the growth of algorithm long, term what's going to drive
the growth of Could guard going.
Speaker 2 (20:39):
Forward the, brand the, awareness the accessibility of the, test
and our commercial organization educating every. Week every single, week
we have eight hundred new healthcare providers that Order coliguard
for the first. Time and what you want to do
is full educate those healthcare providers and your current customer
(21:03):
base of about two hundred thousand healthcare providers that order
Coal guard every. Quarter educate them about the, science the clinical,
evidence and also all of the workflow and reminders and
the importance of rescreening patients every three. Years that is
(21:23):
shown to increase. Adoption and, look there fifty million people
out there in THE us that are not up to
date with col cancer. Screening the reach that we have
with digital and social is becoming more sophisticated that messaging
that we, have and so you want more than, awareness
you want to then drive somebody to action to take
(21:45):
control of their own. Health and we're doing that and
we're at a period of real. Inflection there was eighteen
percent growth last, quarter and that's eighteen percent growth off
a big. Base so we're really proud of what the
team is doing to make colon cancer screening. Inevitable got?
Speaker 1 (22:07):
It within the patient, population you HAVE i guess new
patients and then you have. Rescreens what does that split
look like from a percentage basis or a total number of.
Speaker 2 (22:15):
Tests it's about in the neighborhood plus or minus of
thirty percent of the volumes today are rescreened. Patients and
if you kind of look at it in, totality there
have been a right around twenty two million total tests
and about approaching eighteen million unique. Individuals but this is
building over time because the ramp has been so. Steep
(22:36):
the bulk of the people who have been screening have
been screening in the last few, years and since it's
an every three year. Test what you're seeing is a
rapid increase in the eligible population, too that is eligible for.
Rescreen last year there were one point six million people
eligible for. Rescreen this year it's two. Million next year
it's two point six. Million so that's building over. Time,
(22:59):
Yes and what is the adherence of those? Rescreens is?
It it's incredible if for a second time user it's eighty.
Percent For, wow a third time user it's ninety, percent
and h for a fourth time user it's ninety five.
Percent fourth time. User were they in the original cohort in?
Thousand the original cohort one of THOSE i would. Hope so.
Speaker 1 (23:27):
Moving, move maybe just switching gears because we've been spending
a lot of time on the screening. Portfolio if we
switch over to the precision, oncology you've had some good
news there with anco. Detect you, know there's a lot of.
Stuff we'll get to the blood based correctal cancer, screening
but maybe let's start with onco. Detect how do you
see this market unfolding in minimum residual disease testing OR mrd.
(23:49):
TESTING i, mean there's increasingly a whole lot of players
looking at the same.
Speaker 2 (23:53):
Space there are and our story goes back to twenty
nineteen WHEN i my Friend Kim Popo bits and we
had a conversation about bringing exact sciences And Genomic. Health
kim WAS ceo Of Genomic. Health together as one powerful,
Company Genoma health had reached has reached to about ninety
(24:18):
percent of oncologists in THE us through anchotype D, x
which is a test that has transformed guiding treatment for
breast cancer. Patients so our view WITH mrd is, that
first of, all we think it's going to transform the
way that people are treated with. Cancer and being able
(24:40):
to detect recurrence of cancer up to a year before
you could see it on A pet, scan that's. Powerful
and how does that change the way that you potentially
increase the treatment or decrease the treatment if a patient
is negative for several. Years and IF i can just
for a, MINUTE i have a friend who is diagnosed
(25:01):
with kidney, cancer with stage four kidney. Cancer sorry to hear. That,
well the incredible thing is after being on k, truda
have a NEGATIVE mrd tests for three or four year
period of, time she's been able to go off k
trudah in pet, scans MR d test is negative and
HER pet scans. Negative so now she's able to go
(25:24):
off k truda and she's healthy and, happy and it's
a powerful story that gives a clinician confidence to make
a treatment. Decision so where is kind of our entry
point into this, field knowing that this is not a
field that we, created it's the strength of the fact
that we see about fifty percent of all breast cancer
(25:47):
tissues in Our Jenoma health lab, Our Redwood City Exact sciences.
Lab we see that samples from patients in ninety nine
countries around the, world so we have a global. Reach
we have the starting. Point many, oncologists most community on
collogists treat more than breast. Cancer they treat patients with
(26:10):
all different types of, cancer so we can expand from.
There we also have strength in colon cancer because Of
colon guard and so that's actually our First medicare coverage
is in colon. Cancer so we'll be able to expand from.
There AND i don't think that we'll be in third
place in this. Field that's under.
Speaker 1 (26:28):
Sure so do you have The medicare coverage decision and
Correctal it sounds like you're going to pursue the other.
Cancers do you go AFTER adlt for this at some
point likely is that helpful to the, profile the financial,
profile or does it make it more difficult for some
reason that MAYBE i don't.
Speaker 2 (26:48):
UNDERSTAND adlt is the is the pricing mechanism that there
are two ways to pick pricing mechanism that allows you
to choose your price for the first nine months or,
so and that is one is having something new and.
Innovative the other is GETTING fda. Approval, Right so we
(27:09):
would pursue this, path most likely with THE fda, approval
which would allow us to then have A dlt. Pricing
but we have pricing today and we're happy with the
launch that is that we launched On Goo detect earlier this,
year and now we're we're bringing it to the physicians
(27:29):
and patients that we serve already with our precision oncology.
Business got?
Speaker 1 (27:34):
It how does that market unfold from a clinician, perspective
BECAUSE i Imagine i'm a community, oncologist and there's, yourselves there's your,
competitors maybe they're all coming. IN i, Mean i've got
a pharmaceutical, background SO i always think of, detailing even
THOUGH i don't think that happens in the same way
anymore like it did twenty years. Ago but how DO
i how DO i make that decision as a clinician
(27:56):
which TEST i want to use or is it being
made for me maybe by my.
Speaker 2 (28:00):
Network, well we're PRETTY. Gpo we're pretty early in the
development of this whole. Field, okay maybe maybe ten percent
of patients who should be getting tested WITH mrd are being.
Tested and so there's going to be a lot of
(28:21):
changes that occur over the next five. Years what are
clinicians looking. For they're looking for, Accuracy they're looking for
ease of, Use they're looking for a trusted. Source and,
increasingly as we have conversations with health, systems they want
to work with one advanced cancer diagnostic company or, two not.
(28:43):
Twelve and SO i think that's one of the opportunities
that we have is to continue to serve these same health.
Systems and that's where having the technology to make electronic
ordering and resulting in billing and prior authorization and reminders
and all of that, seamless that's where we think we
(29:04):
can serve those pay those, customers those large organized health
systems on colleges very. Well then also, quality one of
the wonderful things about ARCHETYPE dx is just it denotes,
quality and onco detect OUR mrd test is we believe
also will denote that same level of.
Speaker 1 (29:24):
Quality, No well, SAID i you, know you AND i
kind of live in this, world AND i think we
think everybody's getting these. Tests, maybe but the reality is
it still is very. Nascent my mother in law had
colon cancer a couple of years, ago and she had
surgery to resect her col and then she's. Fine and
at the TIME i, suggested maybe you should ask your
oncologists About at the, time really signatara was the only,
(29:45):
option and she did ask him and he, said, Well
i'm not really sure What i'm going to do if
it comes back. Positive AND i think that was a
hurdle to. Adoption and now the workflow has changed so
much and the clinicians are so used to actually maybe
ordering these tests that it's becoming a lot more of
the standard of.
Speaker 2 (30:02):
Care it. Is AND i mean that story is a typical.
Story what would you do with a positive? Result you'd
probably treat more, aggressively because if you look at the
data that has been generated in, studies it shows that
a positive result is thirty to fifty times more likely
to recur than a negative. Result so now that oncologists can, Say,
(30:26):
okay what's the full scope of treatment that should, occur
and maybe how often should we be doing pet scans
to look for small metastasis that we could Deal.
Speaker 1 (30:38):
That was actually the key DETAIL i left. Out his
reticence was around what IF i get a positive test
but the imaging is. Negative, yeah BUT i think there's
more comfort now that the positive from the tests is
a true.
Speaker 2 (30:50):
Positive it is there any other test that has as
high of a positive predictive value as that N mr
detail that a positive fifty is thirty to fifty times
more likely to recur than. Not, well that's added in
information that a patient needs to know and an oncologist
(31:13):
needs to. Know, so, yes the level of evidence that
has been Created Sotara natara has done great work in
this field to help unlock value, here AND i think
it's going to change everything in THE us and globally
about how cancer is. Treated lots of things will change
That we're still very early in the.
Speaker 1 (31:33):
Journey do you think these will now are soon become
part of guidelines AND ccn guidelines at some.
Speaker 2 (31:38):
Point that's the hope that it happens. SOON i think
it's inevitable that it does. Happen the question is when
more evidence accrues and, develops and then, again what is
the evidence about what is the next best thing to
do once you have a positive. Result so that's the
next kind of types of studies that are being run right.
Speaker 1 (32:00):
Now, yeah there's a lot of interesting stuff happening in this.
Field so we'll switch gears again and let's go TO
i think where the area debate is most recently in exact,
sciences at least from an investor, perspective is around the
corectal blood. Test you, know you guys Bought thrive a
number of years, Ago you've been developing your own internal,
tests and Now i've signed this deal with Free. Noome
(32:22):
can you just walk me through the think the thought,
process so you know why a partnership and a royalty
deal versus maybe like an outright.
Speaker 2 (32:31):
Acquisition so let's taking a step back and looking at
what is the right test for a. Patient is it,
colonoscopy is it colon? Guard is it a fit test
or is it a BLOOD dna? Test and the evidence
is pretty clear here that colo guard and colonoscopy are
the two most effective, tests meaning that they're the best
(32:55):
at detecting pre cancer's polyps and stage one, cancer the
cancers that are ninety eight percent. Treatable blood tests struggle
to detect those two. Things so some of the guidelines
that are evolving are, Saying, okay a blood test could
be should be used for patients who refuse one of
(33:17):
the higher quality tests colo garder of, colonoscopy and we
think that that is probably the way this market, evolves
that for people who are true, refusers a blood test
is better than no test at.
Speaker 1 (33:33):
All what do you think that number is from a
percentage base at all eligible folks who are eligible for a.
Speaker 2 (33:39):
COLONOSCOPY i think that because of the strength of the
colonoscopy as a, brand col Of guard as a, brand
you're going to see over time maybe only five to
ten percent of people who.
Speaker 1 (33:52):
Opt for the blood based test.
Speaker 2 (33:54):
Or a blood. Test and even, then you, know once
they start getting, screened maybe they will be educated that
there's much more accurate way to be. Screened either colonoscopy
or colal guard would be the approaches that the guideline.
FOLKS i think point, two you, know but it's important
to have an option and that was our thinking with
(34:15):
acquiring the exclusive rights to the test That freedome. Developed
We freedome has its own vision as a company and
that goes beyond their colon cancer blood, tests and our
goal was to, say, okay this is a test that
we can serve patients with who refuse a coal guard
(34:37):
test and at least get them. Screened and so our
thought process of licensing the test was that was the
more economically efficient way for us to bring that test to.
Patients and SO i think we have a very strong
partnership now given our capabilities of reaching. Patients it's with
(35:00):
the thousand people in the field and all of the
technology and relationships with large health.
Speaker 1 (35:06):
Systems that makes sense that the rationale is, that, well
it's not the best. Option maybe for, patients it'll be
for lack of a better, term in your, bag, yes
and they will be coming to exact if they don't
go one of those other.
Speaker 2 (35:17):
Routes, well we know that we have seen over thirty
million colo guard test orders and just over twenty, million
twenty two million completed, Tests so there's ten million people
out there that didn't complete a cold guard. Test you
have similar numbers for people who didn't show up for.
Colonoscopies so is there are a way for us to
(35:40):
get them a kit that they would just take into
a quest blood draw site and have their blood. Drawn,
yeah there, is and we have the ability to get
those the right patients and this is the appropriate unique
patients and to get their blood. Drawn got.
Speaker 1 (35:58):
It we're recording this at the beginning Of, september and
you just had to, appear you, know come out with
THEIR v two results a week or two. Ago you,
know they didn't see a dramatic change in terms of
their their efficacy or a specificity or. Sensitivity you, know
are we Reached AND i don't want necessarily ask you
to comment on your peers, results but are we reaching
(36:19):
the limits of detection and the utility of these tests
in some? Ways is that a concern for? You, well,
scientifically we. Can't we can't get maybe much past where
where the current tests are at from a specificity and sensitivity.
Speaker 2 (36:33):
Level we talked about that earlier early CONVERSATION i had
With Bert vogelstein where he, Said, kevin, hey did you
read my? Paper and what does? Paper it basically showed
he COUNTED dna molecules in blood and that just exponentially
decreases with the stage of cancer and the size of
(36:54):
the pre cancerous. Polyp and they there are peers to
be a biological barrier as you would. Expect, look your
colon is designed to keep things out of your blood.
Supply nature has done a very good job at. That
if it, didn't we wouldn't. Exist so, yeah we probably
are reaching that limit at least WITH, dna but will
(37:17):
never stop. Looking is that some other class of marker.
Speaker 1 (37:22):
That whether it's methilation or protein or whatever it might.
Speaker 2 (37:25):
Be whatever it might, be whatever it might. Be and
we have a team in Our Advanced technology group that
that's what they do all day. Long we look at
other people's technology and our view, is, look some of
the best technologies are in the outside our four, walls
not inside our for. Walls so let's be a company
(37:46):
that is capable of bringing in new technology and bringing
into physicians and. Patients that's.
Speaker 1 (37:52):
Great we're getting towards the end of our time here
AND i want to ask you a couple questions on the.
Future and we've talked a little bit about the product road,
apps but you, know one of the great sides you
had in your investor dec as you showed the two
franchises and you started checking off the different products as
you brought them to. Market and you guys have done
a great job recently putting a lot of check marks
up there over the last year or. So and so
(38:15):
as you think about the organization and the heavy lifting
you've had to do to commercialize these, products you, know
what do you have to do now for the harvesting
phase over the next couple of. Years and if we
think about exact three to five whatever time frames appropriate
years from, now you know where do you want where
do you want the company to?
Speaker 2 (38:32):
Be our vision as a company is to help eradicate
cancer with tests that prevented detected earlier in guide. Treatment
what we have built over the last sixteen years is
just the starting point for achieving that. Vision colo guard
On kotype now this broad portfolio of eight to ten
(38:54):
different tests that help achieve that, vision and so we
have an excite five ten years ahead of us where
we're bringing those tests all to the patients and physicians
who need, Them educating, physicians educating, patients running the clinical
trials that create the stickiness with, payers so to increase
(39:16):
their willingness to pay for these, tests educating policy makers
to make sure that our Cancer guard test is widely
available with zero out of pocket Like Colo. Guards so
it's an exciting and fun time to be At Exact.
Sciences there's great, science there's great commercial, efforts and THEN
(39:40):
i think the other thing is making the digital connectivity
with our customers just the best in the. World and
that has been a really fun part of the. JOURNEY
i can't wait for some of these portfolio tests to
start to have an, impact and this year it was
three test, Launches Cold guard, plus Onco detect and Now Cancer.
(40:04):
Guard the team's.
Speaker 1 (40:05):
Busy, well maybe as a corre woray to, that you,
know how are you spending your time differently than maybe
you have in the, Past and as you think about
maybe the year, ahead do you think there's going to
be are you be doing anything different from a day
to day?
Speaker 2 (40:17):
Perspective you, know my days have changed constantly every. YEAR
i felt LIKE i needed to reinvent myself as a,
leader and how you spend your time defines how you.
Lead who do you spend your time, with what do
(40:38):
you spend your time on AND i would say spending
time on company culture is critically. Important spending your time
on science and innovation is critically. Important probably diminishing the
time THAT i spend with investors and letting those results
and teams that work on those things that allows me
(40:58):
to spend more time on the global opportunity with bringing
our tests to the physicians and patients who can benefit
outside THE.
Speaker 1 (41:07):
Us that's well. Said we'll have to do this again
in a couple of years and see where you are
on a global. Basis thank, You.
Speaker 2 (41:14):
Jonathan you know we're so proud of the work that
the team has. Done it's, painstaking nothing happens. Quickly it's,
science it's robust clinical, trials and ultimately you wake up
every day knowing now we're making a tangible impact on
the lives of. Others and if you want to be
(41:34):
part of, That Exact sciences is a wonderful place to
spend your. CAREER i lost my mother this last, week
so sorry to hear. That and she was a nurse
for forty years and a nursing instructor and a. Leader
she helped run a hospital In, Flint. Michigan and one
(41:57):
of the beautiful things that she always kind of reminded
me about my siblings about was it's about other people
and how can you care for them and how can
you make their lives? Better and so for, me it
has been a personal joy to be able to work
for the last sixteen years on helping people improve their
(42:20):
life in a really basic and meaningful, way whether it's
screening somebody and giving them the comfort that they're they
don't have, cancer or whether it is helping to find
a cancer. Earlier it's it's a wonderful place to spend
your life's.
Speaker 1 (42:40):
Work it sure. Is you, know you must have read
my mind BECAUSE i typically ask a very formal question
about you, know what's the mission that drives you on
a day to day AND i think you answered it
in your last. Comments And i'm so sorry for your family's,
loss and thank you for sharing. That this has been
a fantastic, Discussion, kevin thank, You, jonathan and with that
(43:00):
we'll wrap. Up That's Kevin, conroy THE ceo Of Exact.
Sciences thank you so much for joining us on our latest,
episode and please make sure to quick the follow button
on your favorite podcast app or site so you've 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 Bloomberger. Intelligence until next, time take. Care those
(44:01):
are
Host
Jonathan Palmer
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