Exact Sciences Corporation (NASDAQ:EXAS) Annual Evercore ISI HealthCONx Healthcare Conference December 4, 2024 7:30 AM ET

Company Participants

Kevin Conroy - CEO
Aaron Bloomer - CFO

Conference Call Participants

Vijay Kumar - Evercore

Vijay Kumar

Great. Thanks everyone for joining us this morning. I'm Vijay Kumar, the Life Sciences and Device Analyst here at Evercore. A pleasure to have with us, the team from Exact Sciences. We have CEO, Kevin Conroy; and CFO, Aaron Bloomer. Kevin, Aaron, thank you for spending the time with us this morning.

Kevin Conroy

Thanks, Vijay. Great to be here.

Question-and-Answer Session

Q - Vijay Kumar

Great. So, maybe, I'll start with the most topical, we just had the CLFS update, so maybe I'll start with that before we head into the other review of 3Q and expectations of fiscal '25. This was a surprise; the CLFS update was for us. Was it a surprise for you guys? And what's the difference between CLFS and ADLT when you think about what it means to the business?

Kevin Conroy

Vijay, don't you think it's early in the morning for eight acronyms? I mean, here or eight different letters. My brain isn't fully functioning at this point. But let me take a step back and talk about why we're so excited about Cologuard Plus, which is what went through the pricing process and got a price through a particular pathway, the CDLT pathway that Vijay just referenced.

Cologuard Plus is a major improvement to Cologuard. And when you take a step back and you think about screening tests, arguably, Cologuard is the best screening test ever developed and widely adopted in the U.S. in terms of performance, sensitivity, and specificity. The sensitivity of Cologuard, 92% specificity 90%. 87%, if you look at all normals include -- including people with small polyps.

Cologuard Plus, 95% sensitive, 94% specific if you apples-to-apples. That's about a 40% reduction in false negatives, about a 40% reduction in false positives. PSA test, maybe 80% sensitive, 70% specific; mammography, 83% specific. That means you have somewhere in the mid-teens false positives for mammography.

Colonoscopy, you send everybody to colonoscopy, 85% to 95% of patients didn't need a colonoscopy. You, so you could argue the false positive rate is even higher there, and so Cologuard Plus is a breakthrough new product because of that super high level of sensitivity and specificity, and the scientific marvel of Cologuard Plus is that we did it by reducing the number of markers and you hear in our industry, we're scanning 10,000 markers. Cologuard Plus delivers that with three markers.

That's because of the painstaking scientific work that went into identifying those markers and then optimizing the test, and so then the question is, what is the value of this test? And Medicare has a process that is the CDLT process that gets you onto the clinical lab fee schedule. It was hard in that process to get a price that recognizes a greater value than Cologuard because of the limitations of that process.

With that said, CMS looked at it. They evaluated, they evaluated a ton of information. We submitted reams of information and had discussions with CMS and initially, they decided to keep the Cologuard price. They changed their mind, and it surprised all of us that they recognized that higher value and utilized a part of their process to independently recognize Cologuard Plus as a different product and give it a price that recognized the innovation that it is. What does this mean? It means that we have a validity of price from Medicare at $592 compared to $508 for Medicare. That's a 16% difference but this test is more than 16% better. And on a population level basis, it's going to save a lot of money because 40% fewer people going to an unnecessary colonoscopy. That saves a lot of money. And you find more cancers and you find more pre-cancerous. So we also have price stability under this process versus there was another process where we would've had to go through to get a price increase. We're able to keep this price for at least three years. The other process at resets the price every year. So you have that validity of the price, you have the stability of the price, and then you also have a very important advantage, which is speed.

Under this process, effective January 1st, we know what the price of Cologuard Plus is for three years, and that means that we can bring Cologuard Plus to patients sooner. We can do it with starting with Medicare fee for service patients right out of the gate, probably the beginning of Q2. And then with Medicare Advantage plans that we're currently contracted with, and those contract allow or peg off of the clinical lab fee schedule, the CDLT approach. Those would get access immediately. And then we would go through a, we will go through a negotiating process with commercial plans, MA plans, and Medicaid plans, which probably take, start to finish a couple of years in that ballpark. The last time we did this with Cologuard 10 years ago, it was about a three-year process.

We're confident we can navigate that process while we've done it before, and today, Cologuard is covered by 800 plans, almost every plan in the U.S. covers Cologuard.

Vijay Kumar

That's helpful a lot, Kevin. And maybe, Aaron, for you, what does this mean for fiscal '25 rate from a revenue uplift perspective, both revenues and gross margins, if you will?

Aaron Bloomer

Yes. So, as Kevin mentioned, we're planning to launch this in early Q2 of next year, and that's when we'd be able to start shipping out kits. Now keep in mind, it does take a little bit of time from when we ship a kit out until when we get that kit back, anywhere from 30, 60, 90 days. It sort of trickles in over time. And so, Vijay, from a modeling perspective, this would really impact more the back half of next year.

The second thing to note is, as Kevin talked about, this will start with Medicare fee for service, which is roughly 15% of our volume today. The good news now that we're going the CDLT pathway, as Kevin alluded to, is we can begin the negotiation process with those med advantage plans with the commercial plans right away, but it's going to take some time. And so we would expect there on the full year to be, maybe a couple point uplift, on our growth rate concentrated in the back half of the year.

From a gross margin perspective, obviously, within the Medicare population, it's a 16% lift in terms of the ASP and so that will drop through at 100% and then we also have the benefit of about a 5% cost advantage relative to Cologuard. And so we will see a margin improvement from this in the back half of 2025 with an even bigger impact in 2026 and 2027.

Vijay Kumar

That's helpful, Aaron. And maybe Kevin for you. The third quarter was when we had some moving parts, guidance was changed. If you could just walk us through on the commercial side, what happened? What changes were done? I think that would be helpful to understand this whole debate or questions around, are we nearing market saturation for CG, Cologuard?

Kevin Conroy

Yes. Why don't we start with that? Over the years, we have heard, is Cologuard near market saturation. And if you zoom out and look at the screening population in the U.S., there are about a 110 million people who are due for, or who are eligible for colon cancer screening. That is if you're 45 to, age 8 -- 45 to 85 in the U.S. colon cancer touches about, 1 in 18 people in the U.S., in the course of their lifetime. It is the second biggest cancer killer with 50,000 people every year that die from colon cancer. There are a 130,000, 140,000 new cases of colon cancer every year. Everybody in this room is at risk for colon cancer. It is affected by diet. It's affected by smoking. It's affected by family history, but everybody is at risk and everybody needs to be screened and it's a disease that is growing in terms of the frequency in the younger populations. So it's a big problem and everybody needs to be screened.

Today, there are 60 million of that 110 million, 120 million people who are not up to date with screening. 45 million of those 60 million are fully insured and have a doctor. Now there are about 15 million who don't have a regular doctor, aren't insured, but those people can get screened too. There are programs to get those, and we're creating some of those programs to get people screened.

So the question about -- have we hit peak adoption? We're not even close. There have been 17 million Cologuard tests, maybe approaching 18 million now that are, have been -- that we have delivered to patients. Some of them are re-screens and there are 45 million people who still need to be screened. Colonoscopy capacity in the U.S. for screening is 6 million colonoscopies a year, another 6 million for diagnostic colonoscopies. So you can only, if you wanted to screen 60 million people who are unscreen today, you could do 6 million a year for the next 10 years. The problem is that, every year another 6 million people come due. So there's just no way to screen everybody in the U.S. with colonoscopy.

Today, the average wait time is six to nine months. And Cologuard continues to grow, we continue to see adoption in all different areas around the country and segments of the population through different channels, health systems, payers. It's really been an incredible growth story, and it's an open-ended growth story. So we guided down for the fourth quarter and as we had a commercial leadership change in the middle of the year, and we kind of looked, okay, what are we doing with our sales force and really started peeling back the union.

Are we operating, managing, incentivizing, motivating the sales force, which is an incredibly strong team of people, many who have been with us for almost a decade, are we doing that the way that we always did? And we built this incredible brand, probably the most recognized brand and cancer diagnostics and the answer is no. There were five or six things that we did differently over the last three years with the leadership team that came in to Exact, and they did a lot of wonderful things but the sales force, there are things that we can do a lot better the way that we always did. Number one is the sizing of that sales force. We let that the size of that sales force over time, get to be historically low, which doesn't make sense.

We've always slowly grown the sales force to address the huge number of primary care physicians. If you take a typical rep territory, they have about, call it almost 1,000 primary care healthcare providers in a territory. Now, it varies widely depending on what part of the country you are. We call and focus on every rep should focus on about 150 to 200 max. So the opportunity is huge. The question is, who do you call on, which of those healthcare providers see the most patients, are most amenable to getting people screened? And we have the data that allows us to do that which leads to the second thing is we weren't over the last two or three years, we haven't used the rich data that we have, both around Cologuard ordering patterns, new ordering providers, first-time ordering providers.

We know today we will know there will be about 200 first time ordering providers, 150 to 200 today. We know who they are. We stopped reaching out to them. We stopped providing automatically providing their names to our salesforce. We shrunk the size of our inside salesforce, which is incredible, because they're able immediately to call the office, reach out to them, provide them with a demo kit, provide them with a demo video, answer any of their questions. These were the basics. We were maniacal in our focus of making sure that everybody had that data and how we incentivize and compensated, reps and how we organize them into territories. These are some of the fundamental things that look. I've got to be the person that you look to, and I know our Board, looks to, and I know our team, and our employees who are all Exact owners look to say, why did this happen? And I think one of the learning lessons is as you bring new leaders into an organization, you have to put them through a couple of months of Exact Sciences training.

We are not like a pharmaceutical company and so pharma execs that come in into Exact need to say, oh, this is a really device company? Are we a diagnostic company? We're pretty unique because we're a consumer company in many ways, and we're a health care company. So it requires a different way of thinking. We also market and reach people in different segments of the population in very different ways.

We do it with digital. We do it with social. We do it with TV. We do it with radio. We do it with text. We do it with direct marketing. It's very, very different than any other health care product, and we have developed proprietary capabilities to reach people. So we believe that as we have now optimized our approach to incentivizing, organizing, motivating this incredible team of salespeople that we will see, continued robust growth from our customer base and just to zero in on one aspect of our customer base. That over the last couple of years, we haven't focused on enough, and that is the 800 to a 1,000 new first-time ordering healthcare providers every week.

That they are surrounded with attention and education about Cologuard. So they order -- why did they order Cologuard without us visiting them first? Well, it's because their patients saw an ad either on their phone, or on TV, and they came in, and they asked for a Cologuard and the doc says, yes, I can order a Cologuard. Let me look it up. It's right there in their electronic orderings in their EMS system, whether it's Epic or Cerner. They can order electronically largely today. They couldn't 10 years ago. So that's our -- we'll get into this, but Exact Nexus is our tech stack.

And, every quarter, at a minimum every quarter, in a very short period of time, it will be daily, you will get updates on who the new ordering providers are in your territory that are high potential and you should be calling on. And the way you organize this is you have kind of super core physicians that you focus on, core and your base. That comprise your, call it a 150-plus healthcare providers that you focus on, and you call on them in different levels of frequency.

The reason that you want to focus on those new ordering providers, if you look at the data, the new ordering providers over the last three years that you call on frequently, they go from let's say, roughly 5 to 6 orders in the first quarter that they order to 10 to 12 Cologuard orders several quarters later. Don't want to provide too much information here for modeling, your modeling purposes but, if you don't call on those, they stay at about 5 to 6 per quarter. They just don't prioritize colon cancer screening or they may send the patient to colonoscopy because it's muscle memory in their electronic ordering system. So, that's the opportunity that we have is to focus on those new ordering providers like we always did. We always had this program called no order left behind, every single order that came in from a first time provider, got a telephone call, got email, got outreach, and that from an inside sales rep, then the field would reach out to them and we would make sure that every provider felt that they were part of the Exact Sciences, Cologuard family from the get go.

Vijay Kumar

That's helpful, Kevin. How long since you made these changes, cells is calling this new cohort of physicians, right? How long does it take for us to see a chain in ordering patterns?

Kevin Conroy

In our experience, when you make changes to the deployment of a salesforce, it takes a few quarters before you can really make that impact and it's just a math exercise of how long does it take you to get to those healthcare providers as frequently as you want to get to them to really move the needle. We'll start to see signal internally in the first quarter, but it's going to take a few quarters for that to have a major impact.

Vijay Kumar

That's helpful. And Aaron, I think beyond, the salesforce changes, I think, hurricane and Nexus were a couple of items you called out which had some impact in Q4. What was the impact and are these now revenues, which should come back in Q1 or what sort of right framework to think about revenue push out?

Aaron Bloomer

Yes, if you look at the guidance reduction that we had, roughly a third of it was related to transitory or one time impacts. You called out the two hurricanes were roughly half of that. And obviously in this region specifically, there was two devastating storms that came through. We saw both orders and receipts significantly slow for a period of time. The encouraging news is both orders and results are kind of now back to where they were pre hurricane. And so it typically takes, a quarter or two for it to just to kind of catch up. And so, we see this impact here in the fourth quarter and into the first half of next year.

The other one was related to putting our U.S. Oncotype DX business onto our exact Nexus proprietary IT platform. And there was just, it's one of the aspects is a billing system. And as we'd made this transition, we just had some receivables that were at risk for our write-off, where we weren't able to get all of the proper paperwork and billing prior authorizations required to be able to collect on that. That was definitely one time in nature that's resolved. Our cash collection rate is now back to where it was pre-transition, and we would expect to see improvements to that over time, similar to what we saw when we put Cologuard onto our Exact Nexus platform.

Kevin Conroy

Let me just describe what the Exact Nexus platform is. So the Exact Nexus platform is a EMR system that allows you to electronic medical record system. It's built on Epic, the leading EMR system, and it has a ton of functionality that surrounds that. It allows electronic ordering, electronic resulting, it allows electronic billing, which is a major capability for a diagnostic company. It allows prior authorization. It allows data analysis in a way that we can use to deploy our field force to call on physicians. It has this unlimited potential because it also allows us to engage with customers, patients in a way that we can get them to return a Cologuard kit sooner because we can text them, we can email them. All through this text stack that is proprietary. It has taken a huge investment. And, this bringing Oncotype DX onto the platform will allow us over time to realize a higher percentage of what we bill, that we collect.

And I'll tell you a story about Cologuard. Cologuard was -- we had a team of about 750 people to send out bills, and this is back when we were screening a one million patients a year. We probably had 700 people just sending out bills. And you'd get -- you'd collect, what call it $0.80 on the dollar, $0.85 on the dollar, 60 days later.

Today, you have a much smaller team. So you've been able to redeploy resources into other areas, and you collect in about 20 days. And you realize, what is it, mid-90s?

Aaron Bloomer

Mid-90s. Yes.

Kevin Conroy

So that's the power of this tech platform. It you -- it's just not available. You can't go build this on your own. It'll break you. It is a combination of best-in-class technologies. And I'm just -- it's part of the team at Exact Sciences that doesn't always hear how awesome they are, but it's our technology team. A team of altogether approaching a 1000 people internal and external that built, maintained, and they keep pushing the boundaries of what the tech platform can do.

Vijay Kumar

And that's helpful color, Kevin. I think you made some comments about fiscal '25. You sounded optimistic on rescreening and care gap program, right? Maybe talk to us on rescreening. What is that opportunity? How much can it drive growth? What are the assumptions underlying it?

Kevin Conroy

So rescreen. Rescreening is Cologuard is a test that you don't use once in your life. You should use every three years for the rest of your life. If you'll die of something, but if you do that, your odds of dying of colon cancer plummet because you over time, find, and remove the pre-cancerous polyps and actually prevent cancer. Your odds of being diagnosed with colon cancer plummet, much less your odds.

So the rescreen process in the future, we believe will be totally automated. So, shortly before your third year anniversary, you'll get a Cologuard test that you'll return on your third year anniversary, and it's just automated. Today, between 50% and 60% of people who are due for a rescreen and eligible for a rescreen get rescreened. So there's a huge opportunity for growth.

The reason that this compounds over time because you -- next year, you have people who are due for their fourth Cologuard and another group that are due for their third Cologuard and and a, big group that are due for their second Cologuard and that just keeps growing over time. And they, that build so this year, I think it was about, what was it, 1.6 million people were eligible.

Vijay Kumar

Yes.

Kevin Conroy

For a rescreen. Next year, that's 2 million. The year after, it will be 2.6 million, and it grows from there. So you think we will move from eventually in the next several years to over 50% of our Cologuard revenue or screening volume is just this automated people do every three years? And this is what the modeling suggests and the guideline group recommends is every three years to get rescreened. So it's an important part of making sure that those 16 million people who are not up to date were screening stay up today.

Aaron Bloomer

And as Kevin said, it's got an exponential growth factor into the future because as you talked about, you're stacking the first, second, third, fourth eventually fifth rescreen all on top of one another. And although the kit return rate right now is between 50% and 60%. What's interesting is the biggest challenge as to why that number is not higher is actually getting the prescription regard. And so once a kit is actually shipped to you as a patient, you actually completed 80% of the time for a first-time time screener, 90% for a second-time rescreener and so the power of the exact Nexus platform that Kevin talked about and the relationships, we continue to strengthen with our health systems, with our payers will allow us to get a lot better at this such that, as Kevin alluded to, when you become eligible for your rescreen on the three-year anniversary date, we're automatically shipping that kit out and so we're removing the barrier from the 50% to 60% to the 80%. It provides a huge opportunity for us into the future.

Vijay Kumar

And that itself, 1.6 eligible going to 2 million with perhaps increase in compliance rate, that should drive mid-singles uplift to screening revenue growth of '25?

Aaron Bloomer

Yes. So next year, as we think about growth reaccelerating, I know we'll talk about care gaps here in a minute as well, but rescreens alone, which is its highly predictable recurring form of revenue and highly accretive gross margins as well because the kit return rate is so high. That gets us to mid-to-high single-digit growth in 2025. you've got the robustness around our care gap program, the demand for that. Those two things together gets you to something north of 10% growth. And then as we talked about with Cologuard Plus adding a couple of points. The commercial execution, as we talked about is going to take a couple of quarters, but that's kind of how we stack it together, Vijay, to get to growth acceleration next year.

Vijay Kumar

That's extremely helpful, Aaron. And Kevin, can you touch upon this care gap program? Is that sustainable? What is driving this care gap acceleration?

Kevin Conroy

These care gap programs are basically health systems and payers means of going to those 60 million people who are not up to date with screening and getting them screened on an automated basis. For a couple of decades, they've been sending out fecal immunochemical tests, these what is called a FIT test, mailing them out to patients and hoping that they get 10% back. Why are they motivated to do it? They care about their star ratings, their quality measures. It's a range of 33 different measures and Medicare Advantage plans stand to gain a ton financially if they improve the preventive and overall health of their population that they're responsible for as measured by quality measures. Colon cancer screening is one of them.

So we have worked very closely with payers and large health systems to help deploy Cologuard screening at scale. The -- I'll give an example, one big Blue Cross Blue Shield plan came to us and said, we want you to screen these 90,000 people. First of all, we're able to take the data that we have resident within Exact Nexus and compare it to the list that they just gave us and go back to them and say, well, these X thousand people are actually up to date and you don't know it. So you actually get that credit for free. Just those people are up to date, here's the date that they're going to be due. We can come back to those people. The remainder, we work with that payer and the payer or a third party issues prescriptions for those patients for Cologuard and you're able to screen -- send out Cologuard kits and communications and engage with those patients to get them screened.

Both the challenge and the opportunity with this group is that you see about 20% -- this year today, 22% of the kits have been returned, 24% in the third quarter compared to 67% if a patient gets a Cologuard test through an encounter with their health care provider. So there is room to triple what we're doing there. And yesterday, we announced that at least it's actually more than 200,000 patients will be screened this year through these care gap programs. This is going to -- we see in the not distant future, the ability to get to multiples of that and one of the ways you do it is just to improve the kit return rate. How do you do that? Better communications with patients. And maybe, Aaron, you can talk about the study that we shared at ACG.

Aaron Bloomer

Yes. So we partnered with one of the Med Advantage plans, and we published this in a paper at ACG, where we were allowed and worked with the Med Advantage plan to turn on the whole suite, the surround sound that we surround the patient with text, e-mails, digital reminders, post cards, mailers, et cetera and we actually drove a 50% kit return rate. So we've demonstrated the ability to do this. It's just going to take some time, and it's something that we will work to improve over the coming years.

Vijay Kumar

And maybe one more on this care gap, Aaron. The contribution in fiscal '25, is that being driven by an increase in volumes under care gap program? If so, what gives you the visibility, right? Have you had these conversations with payers, providers.

Aaron Bloomer

So the team that we have that's working on this, it's a really small team who've just done a phenomenal job building this program out. We didn't even really have this 18 months ago, and it's now grown as Kevin said, in just a short period of time, more than 200,000 completed tests and so we've got over 50 active programs with health systems and payers today. We're in very close engagement and communication with them. We have line of sight. There's several different kind of growth drivers for care gaps as we head into 2025.

One is we have many kits out in patients' homes today. So because of the fact that the kit return rate is closer to 24% here in this last quarter. There's many kits that are out in patient's home, and we're going to turn on the suite of Exact Nexus to be able to communicate with those patients and an opportunity to get them back.

The second is, as we've worked with all of these payers and health systems, they've given us only a fraction of their patient population and so there's an opportunity for us to be able to work with a different cohort of patients who continue to remain unscreened. A third area is growing the pool. And so while we've made a lot of progress with health systems and payers, there's a number of health systems and payers, many of which we're not yet working with today and are still using the FIT program.

And then the fourth driver would be boosting that compliance rate. Last year was in the high teens. In terms of the kit return rate, we drove that up to 24% in Q3, and we'd look to improve on that over time as well.

Vijay Kumar

Understood. And -- sorry, just to put a finer point on that. Is that -- are we assuming that 24% return rate that goes to 30%, something like that for -- to drive revenues?

Aaron Bloomer

There's a small improvement in the kit return rate when I talk about rescreens and care gap kind of adding in total to be north of 10% but it's going to take us time in partnership collaboration with the payers and health systems to drive that up to something closer to 50% over time.

Vijay Kumar

Got you. And maybe switching on to some of the pipeline products, Kevin, MRD and blood 2.0 comes up. Maybe on MRD, right? You guys sort of a second entrant to that market. What is success for you in MRD? How do you plan to penetrate that market? Do you need differentiated clinical data and what gives you the confidence that you have a differentiated offering?

Kevin Conroy

Let me first highlight the top 4 programs in our pipeline and then come back to MRD. So MRD Onco Detect will come back to Cologuard Plus. We've talked about CRC blood and then multi-cancer screening. Our colon cancer blood test, we expect a readout next -- in 2025 next year, hopefully, in the middle of the year we shared some really exciting data showing, for the first time, a significant lift in the detection of pre-cancerous polyps and one of the reasons we had the confidence to share that data is the samples that we use came -- 60% of those pre-cancers came from a prospective study. We're always suspect of data when it comes from what's called a case-control study when you -- retrospectively when you collect a blood draw after somebody has had a colonoscopy, which creates a bias.

So we saw data here that detected 31% of advanced pre-cancerous lesions or these pre-cancers. In a prospective study, we would expect to see degradation, but still, hopefully, better than what others have been able to do in that field with 88% cancer detection and 90% specificity. To be clear, we don't even know -- I mean if the guideline group follows their typical path, these blood tests probably don't make it into the guidelines, so they don't make it another quality measures and so it becomes a kind of ancillary way to screen if people refuse other forms of screening. If by chance the guideline committee throws their current method out the window and says, no, we're just going to include blood testing as a recommended type of screening, we'll be able to deploy our field force and our exact Nexus drop this into that, and it will be Cologuard or blood. We would favor Cologuard because it's just an amazing high-performing test.

So then you have multi-cancer early detection, which is one blood draw most cancers. We had data that we presented at ESMO recently that showed when you combine our -- the technology that we've developed over the years with the Thrive acquisition that's DNA methylation plus DNA mutations plus proteins, you see the incredible performance. 56% overall cancer detection, 66%, 67% in the six most aggressive types of cancer. So and that is at a 98.5% specificity, only 1.5% false positive rate. We can do this at a cost structure that nobody else has been able to with a minimal of sequencing costs. So the cost of goods is down in the $160 or less, meaning that for $500, $600, $700 somewhere in that range. We have a test that if you're 50 years old or older, there's 3% of the population in those older age groups in the U.S. are walking around with cancer, and they don't know it and they're going to be -- that cancer will be found symptomatically. And if it's symptomatically, it's usually late stage and if it's late stage, you have -- it's not a good thing for patients and if we can stay ship to earlier. So we're excited about the ability to bring this test to patients most likely first as a lab-developed test and we're running a 25,000-patient clinical trial right now. That's a prospective clinical trial that will add to the evidence.

Coming back to our MRD test, Onco Detect. We expect to have data in late January and submit that data in the publications for Medicare coverage during the first quarter and launch in the second quarter. Our test looks for 50 to 100 mutations -- and that we believe that will confer strong sensitivity. Let me take a step back. Why would you use an MRD test. Well, if you're a patient that has, let's say, stage 3 colorectal cancer, the question is, what -- how long should you be on chemotherapy.

So after surgery, after your initial chemotherapy, the question is, is there still circulating tumor DNA, did surgery to that initial adjuvant therapy, did it get all of the cancer and the MRD test is a blood draw that is a bespoke task based upon the mutations that you find in the tissue. And the work that has been done and Natera has done really the right incredible scientific work to show that you separate patients into two cohorts. If you have circulating tumor DNA at that point in time, you are likely to recur over the next two years, three years. If you have no circulating tumor DNA, you're not likely to recur.

So now you can focus treatment, more aggressive treatment on the patients most likely to recur. Those with still circulating tumor DNA. And you can see that tumor and blood 6 to 12 months before you can see it on a PET scan. You can also test every 3 months and then 6 months and then annually over time to get that recurrent if recurrence does happen, that you're able to identify and treat sooner. This market is going to evolve for a long period of time.

Our first test version is the data that you'll see in January. We have version 2 that we will deploy for breast cancer, which sheds less DNA that will look for 500-plus mutations, more mutations, theoretically greater sensitivity. We have deep relationships with oncologists because Oncotype DX has been used by 98% of oncologists in the U.S. and is preferred by 90% of oncologists in the U.S. So we have had deep relationships. They trust us with the tissue. They trust us with billing. They trust us with customer service. And this is an exciting new field, and we hope to participate in it.

Vijay Kumar

And just maybe on those two points. On blood, just to be clear, you expect your performance to be at or about what's out there comparatively. And on a similar kind of question, will this be clinically differentiated.

Kevin Conroy

So is the blood test that you referred to, which...

Vijay Kumar

CS CRC blood, Will that be similar or about versus whatsoever?

Kevin Conroy

You find out when you unblind the data. Our studies to date show us that because of our approach, -- we believe we have the ability to deliver better performance than what you have seen out there. We will see when we open the database. So people keep asking, Kevin, what do you think it's going to be? I don't know. I can only guess. And guessing is probably -- the data is coming in the next 6 to 9 months and the science is sound and the clinical studies are sound. The last data that we released, I encourage you to go take a look at it. It's 3,000 patients. Most of those samples were prospectively collected.

The normals came from the pivotal study, we randomly pulled normals out of that study. So that's specificity, the false positive rate is calculated from those patients, the error bars on that are tiny, and it's the same patient population. So confident in the specificity, the sensitivity is the big question. We believe that we will pass the Medicare bar that we will be at or better than those other companies that are trying to get into the space, especially with pre-cancer detection.

Vijay Kumar

Got you. And sorry, a similar question on MRD. Will that be a differentiator versus what's available in the market?

Kevin Conroy

The goal is to have maximum sensitivity, especially at that first point in time, maximum specificity for the -- looking for recurrence. And we'll see. Again, there's data coming there, and we'll share that data in late January.

Vijay Kumar

Great. With that, I think, unfortunately, we're out of time. Kevin, Aaron, thank you for the time this morning.

Aaron Bloomer

Thanks, Vijay.

Kevin Conroy

Thank you, Vijay.