Good day and thank you for standing by. Welcome to the Exact Sciences Corporation Second Quarter 2021 Earnings Call. Please be advised that today's call is being recorded. I would now like to hand the conference over to your speaker today, Ms. Megan Jones. So please go ahead, ma'am.

Thank you, Ria. And thanks to all of you for joining us for Exact Sciences' second quarter 2021 conference call. On the call today are Kevin Conroy, the company's Chairman and CEO; and Jeff Elliott, our Chief Financial and Chief Operating Officer and Jake Orville, General Manager of our Pipeline. Exact Sciences issued a news release earlier this afternoon detailing our second quarter financial results. This news release and today's presentation are available on our website at exactsciences.com. During today's call, we will make forward-looking statements based on current expectations. Our actual results may be materially different from such statements. Reconciliations to GAAP figures are available in our earnings press release, and descriptions of the risks and uncertainties associated with Exact Sciences are included in our SEC filings. Both can be accessed through our website. It is now my pleasure to introduce the company's Chairman and CEO, Kevin Conroy.

Thanks Megan. And thanks to everyone for joining us this afternoon. We tested 850,000 people in the second quarter with Cologuard and Oncotype DX in our COVID test, the Exact Sciences team remained unwavering in their dedication to our mission and delivered record results with Cologuard and Oncotype. The team delivered in spite of limited salesforce, and in-person wellness visits due to COVID. Exact Sciences is a leader in advanced cancer diagnostics because of our people, our capabilities, our scientific platform, and our powerful brands. We will transform cancer care with our strong foundation and screening and precision oncology in our pipeline of innovative tests. We have a relentless focus on creating a great company culture with the best team. We are inspired to achieve our mission of cancer eradication. Because of this passion and engagement, Exact Sciences was recently certified as a great place to work for the third year in a row. Today, we will review our second quarter performance, third quarter and full year guidance and our progress for 2021 priorities. Our CFO and COO, Jeff Elliott will now review our financial results.

Thanks Kevin. Good afternoon, second quarter revenue was $435 million, an increase of 62%. Screening revenue was $264 million, an increase of 101%. Screening revenue would have been $276 million but for a one-time downward adjustment of $12 million. The downward adjustment was taken because we missed the contractual deadline for submitted insurance claims on a small percentage of previously completed Cologuard tests. The adjustment represents 2% of screening revenue during the relevant time period. We are addressing this by improving our billing systems and processes. And we're confident these enhancements will support a rapid growth in new product launches. Highlights for the second quarter include the highest number of people tested for Cologuard by more than 60,000 tests. A significant increase in the number of lives covered for Cologuard in the 45 to 49 age group. Solid contributions from three-year rescreening, a two-point improvement in the Cologuard electronic ordering rate to 45%, and 8,000 new healthcare providers ordered Cologuard during the quarter, and nearly 244,000 of orders since launch. Turning to Precision Oncology, second quarter revenue was $138 million, an increase of 34%. Growth was primarily driven by Oncotype DX breast in the US and internationally. COVID testing revenue was $33 million. Second quarter GAAP gross margin was 69%. Non-GAAP gross margin, which excludes amortization of acquired intangibles, was 74%. Sales and Marketing expense was $195 million. The increase was due to investments in our sales and marketing campaigns to support growth. General and Administrative expense was $168 million, including $13 million of acquisition integration costs. Research and Development expense was $106 million, and included $33 million for the acquisition of PFS Genomics. Aside from PFS, growth was driven by a multi-cancer screening test. Adjusted EBITDA was a loss of $27 million, and we ended the quarter with cash and securities of $1.3 million. Turning to our 2021 outlook. We now expect revenue between $1.705 billion and $1.745 billion, an increase of $10 million to $15 million for the year. We've slightly lowered our screening revenue assumption, and now expect between $1.1 billion and $1.125 billion. We've increased our Precision Oncology revenue assumption, and now expect between $530 million and $540 million. We've also increased our COVID testing revenue assumption, and now expect between $75 million and $80 million. For the third quarter, we expect revenue between $420 million and $435 million, with screening revenue of between $285 million and $290 million. Precision Oncology revenue between $130 million and $135 million and COVID testing revenue between $5 million and $10 million. There are two main pandemic-related dynamics impacting the screening business: reduced physician office access for our field teams, and fewer in-person wellness visits. Since our last earnings call, we have not seen as much improvement in these two factors as previously expected. This is in part due to the recent uptick in COVID cases from the highly contagious Delta variant. Starting with field team access, it is very promotionally sensitive. The more times we talk to a physician about Cologuard, the more tests they order. In-person sales calls have been gradually improving, but they're still well below pre-COVID levels. 55% of primary care physicians are not allowing sales representatives into their office, according to a recent survey we conducted. In offices where we have physician access, we're seeing rapid increases in Cologuard orders. Secondly, in-person wellness visits are limited. Cancer screening and conversations and Cologuard orders typically occur during a routine wellness visit. That's different from most advanced diagnostics, which are ordered outside of wellness visits. Our survey showed 44% of primary care doctors are doing fewer in-person wellness visits when compared to pre-COVID levels. Turning to operating expenses; for the full year, we expect sales to be in the range of $800 million to $850 million. For General and Administrative, we are raising our guidance to $600 million to $625 million, excluding integration costs. The increase is mainly due to investments in our IT and customer service teams to support our continued growth. For Research and Development, we expect $410 million to $435 million. The acquisition of PFS Genomics was expensive in the second quarter, adding in $33 million in R&D costs not contemplated in prior guidance. We continue to expect around $95 million for tangible amortization and CapEx of around $125 million. I will now turn the call back to Kevin.

Thanks Jeff. Exact Sciences is focused on three priorities this year: getting more people tested, enhancing our customer experience, and advancing new solutions. Starting with our first priority, Cologuard was designed to help screen more people for colorectal cancer and find it earlier when it is curable. According to recent CDC data between 2015 and 2018, Cologuard helped improve screening rates for Americans 50 and older by four percentage points. Our survey data show nearly half of Cologuard users have never been screened for colorectal cancer. Since Cologuard was made available, we estimate it has helped detect precancerous polyps in more than 200,000 people and early-stage treatable cancer in more than 30,000 people. Cologuard is especially well-positioned to help screen the 19 million Americans ages 45 to 49. The final USPS recommendations expanded the screening population by lowering the starting age from 50 to 45. Colon cancer incidence in this age group has increased more than 50% since the mid-1990s. People in their late 40s typically lead busy lives and Cologuard's accuracy and convenience makes it an ideal option to keep them screened for decades. A recent study published in Cancer Prevention Research showed that Cologuard's specificity is greater than 95% in this age group. This means that fewer than one person will receive an unnecessary colonoscopy following Cologuard, helping screen many people without pressuring colonoscopy capacity. Since the guidelines were finalized, we've seen a significant increase in Cologuard coverage for 45 to 49 year olds. We recently launched a national Cologuard television, digital, and social media advertising campaign aimed at educating 45 to 49 year olds about the importance of screening and the benefits of Cologuard. We're making it easier for people to stay up to date with screening after an initial Cologuard test. The number of rescreen eligible patients is growing. This year, more than 600,000 people will become eligible for another Cologuard test. Next year, more than 1 million people will become eligible. We're investing in technology to stay connected with our customers and make ordering easier. This gives us confidence we can help keep people screened with Cologuard for years to come. Our Precision Oncology team is providing better information to guide patients in their cancer treatment decisions. We have established deep relationships with oncologists, pathologists, and surgeons. Nearly half of our oncology sales representatives have been educating physicians about our Oncotype test for at least nine years, creating strong brand recognition. Following our acquisitions of Paradigm and Ashion, we're now offering therapy selection tests for patients with advanced cancer, providing even more value to oncologists, researchers, and pharma partners. Our international team and the powerful evidence backing our Oncotype DX breast test are enabling new areas of growth around the globe. Supported by the TAILORx and RxPONDER studies, our Oncotype DX breast test was recently approved for national reimbursement in Italy. This makes Oncotype accessible to nearly 25,000 breast cancer patients in Italy. Our international presence will accelerate the availability of future advanced cancer tests all around the world. Moving to our next priority, Exact Sciences plans to transform cancer care by providing patients valuable insights at every step of their diagnosis and treatment. We are working to build the best digital infrastructure and diagnostics. Our vision has two main elements: first, enabling patients to take a more proactive role in their care; second, making it easy for physicians to order tests, interpret results, and personalize medicine by applying real-world evidence and guideline recommendations. Imagine a world where a patient uses an interface on their phone to interact with a physician for cancer prevention, diagnosis, and follow-up. They complete an Exact Sciences multi-cancer screening test and can monitor the status of their results virtually. If the test result is positive, a support system can help schedule a PET CT to confirm their diagnosis. If cancer is found, an Oncotype test may be offered to help determine disease aggressiveness and treatment options. In the coming years, we'll remind the patient to complete testing periodically through that same interface, monitoring for residual disease and cancer recurrence. If the cancer returns after initial treatment, Oncotype MAP can be ordered to help quickly guide them to potential treatments. Our powerful IT systems will make working with Exact Sciences an easy decision. The information collected across a patient's health record will automatically translate into actionable options for physicians; we will help provide the right test at the right time, partnering with providers to help bring guideline recommendations to life within their native electronic medical record system. Turning to our next priority. Over the next 24 months, we're planning several key milestones to bring six innovative cancer diagnostics from our pipeline to patients in need. This is a combination of more than a decade of work by the Exact Sciences team and our partners, including the Mayo Clinic, Johns Hopkins, and now City of Hope. Starting with multi-cancer, next year, we expect to share case control data demonstrating the power of combining methylation, mutation, and protein marker classes. We also plan to initiate a prospective interventional randomized trial for FDA registration. Moving to Cologuard 2.0, we plan to share additional case control data supporting our goal to improve the specificity of Cologuard while maintaining sensitivity. For colon cancer blood testing, we plan to share case control data, providing an initial look at test performance. For Cologuard 2.0 in colon cancer blood, we plan to announce top line results from our prospective BLUE-C study to support FDA approval of both tests and help cement our leadership in colon cancer screening. In the area of minimum residual disease testing, we expect to generate clinical validation data for tumor informed liquid biopsy tests. In therapy selection, we plan to release clinical validation data supporting a blood-based version test, Oncotype MAP. Finally, we expect our Oncoguard Liver manuscript to be published in a peer-reviewed journal. This publication will support a Medicare reimbursement submission and future guideline inclusion. We're excited about the depth and breadth of our pipeline. Our scientific capabilities combined with our commercial scale will help us provide several new life-changing cancer solutions to patients in need. The Exact Sciences team is energized to continue growing Cologuard and Oncotype and bring new innovative tests to patients throughout their diagnosis and treatment. Our capabilities, relationships, and foundation will help us achieve our mission of eradicating cancer through the power of advanced analytics. We're now happy to take your questions.

And your first question comes from Brandon Couillard from Jefferies.

Thanks, good afternoon. Jeff, in terms of the screening guidance for the back half of the year, it would imply that 4Q growth sequentially steps up to something like 11%, despite what is typically weaker seasonality. Can you just talk about kind of what went into your assumptions for 3Q and 4Q and your level of comfort with that scenario and kind of what it contemplates in terms of access and maybe an uptick in wellness visits?

Yes, to start with the guidance adjustment for the second half of the year, we are making a total adjustment of $25 million for screening. About half of this is tied to the $12 million one-time adjustment from the quarter. The other half is related to temporary pandemic factors, specifically physician office access and wellness visits. In response to your question about the second half of the year, we anticipate continued modest improvements in physician office access and wellness visits. We have observed that when our representatives are able to visit doctors, they effectively educate them, and repeated visits lead to increased orders—a trend that has held true historically and continues to be the case. However, currently, 55% of physicians we surveyed are not allowing representatives into their offices. We expect some modest continued improvement in this area. Additionally, I believe the strong momentum we experienced in the second quarter, which was a record quarter surpassing previous years by over 60,000 people, will carry over. We are making solid progress on initiatives like three-year rescreening, and we are on track with the earlier guidance for rescreening. There are many reasons to feel optimistic about the second half, and I believe the projected growth rate for the fourth quarter will be similar to what we've seen in past years. Therefore, I am confident we will meet the numbers outlined in our planning guidance.

And your next question comes from the line of Derik De Bruin.

Okay. Hi, good afternoon. So just can you talk a little bit about the Precision medicine franchise? How much of that was Oncotype? And how much of that is sort of like some contributed for some of the acquired products you've had? And can you also talk a little bit about the competitive landscape there? There's been some chatter from some private companies about some potential share shifts in that market, can you sort of highlight and update us on what's going on in the Oncotype business? Thanks.

The Oncotype business globally had a very, very strong quarter, again, a record quarter for the organic business. There was a small saturation, non-material, but there was a small contribution from acquisitions. And overall, though constant currency growth is north of 30%, I feel very good about the status business. And what it really boils down to Derek is the strong evidence, the unmatched evidence out there, from both the TAILORx study and RxPONDER studies, this gives the teams in the field robust evidence to talk to physicians about and an Oncotype DX is really the standard of care. So no change to that I feel very good about the state of business. And it provides a very robust foundation for us to grow from, whether it's the Oncotype MAP business that we launched just in May, that is now launched onto the entire salesforce, or the GEM ExTra product that we acquired last quarter, the GEM ExTra product is off to a very good start, but most of the growth here was organic, and that franchise is in very good shape.

And your next question comes from the line of Brian Weinstein with William Blair.

Hey, guys, thanks for taking the question. With Jake, on the call here, I think it's a good opportunity to at least ask him for his thoughts about that long list of things that Kevin, that you highlighted as far as what that pipeline really looks like, and really starting to round into shape here. So question for you, Jake, is what are you most excited about here in the pipeline, and why? And then I'm also curious about your view about sort of challenges that you guys face from a technology standpoint, as you look to develop these products? Thanks.

What excites me is the unique breadth and depth of our pipeline. We have a comprehensive portfolio of high-impact tests throughout the entire cancer care continuum: screening, prognosis, minimal residual disease, recurrence, and therapy selection. It's meaningful that we will continue to be a trusted source for innovation with both patients and providers across this care continuum. Alongside our portfolio, we have the team, talent, and scientific expertise needed; we won't just have multiple portfolios, but we'll offer the best tests available. We know that over time, the best tests prevail, and we are committed to bringing these to market correctly with solid evidence. Our strong portfolio, talented team, and excellent expertise give us confidence in delivering the best tests and supporting their usefulness through evidence. What excites me now is our ability to innovate at scale. All of our solutions are now entirely seamless as they integrate into our lab infrastructure, and we utilize our IT connectivity. When we collaborate with our leading commercial team—operating in 90 countries globally—I feel confident that our pipeline can significantly impact patient care.

And your next question comes from the line of Doug Schenkel from Cowen.

Hi, everyone. I had some trouble with the mute button. I want to discuss Cologuard further. Screening revenue appears to have grown by about 10% sequentially, and based on your commentary and some quick calculations, it seems like the volume growth was between 15% and 20%. I want to confirm if that's accurate. On a broader note, we understand the challenges related to access to physician offices, particularly given the current negative trends regarding COVID in the United States. However, it seems that increased Cologuard usage, repeat testing opportunities, and improvements in colonoscopy infrastructure, among other factors you mentioned in your prepared remarks, could serve as positive counterbalances. Given the need for more screening and current low market penetration, I have a couple of questions: Are you completely confident that nothing is obstructing access to physician practices? Are you anticipating that the commentary from other companies during this earnings season will change? Also, do you have concerns that your initiatives to reduce Cologuard's dependence on physician detailing in the long term are not progressing as quickly as you had hoped? Thank you.

I will take that. The reason that we're tremendously excited about Cologuard and where we are in delivering this record quarter is driven by the fact that there are so many primary care physicians and nurses. And when you look at the base of who's ordering, and just to give more details on this, the healthcare providers who typically have ordered the least are ordering at a higher rate than previously and especially compared to historically are the most frequently ordering positions. And what this tells you is that, yes, our Cologuard is always going to be sensitive to two visits by our field force. And that's because of the nature of the patient. The patient here is a patient who comes in who isn't sick. And in a time like this, there's a triage occurring in the primary care setting, focusing on problems with diabetes, obesity, and high blood pressure and other serious conditions that physicians and nurses are triaging. And so they get around to prevention and screening after all of that. And what this tells you the net of this is that there's tremendous strength in Cologuard, and that strength is broadening and deepening. And we know as these offices start to reopen, and as we see more of the appropriate wellness visit patients into the offices, that we will see even stronger growth, because again, it's the best customers who are the ones who aren't growing at the pace that you would expect to maybe Jeff could add to that.

Yes, just add to that, the data Kevin referred to as we look at different quintiles of doctors, and what we see is very encouraging. The bottom 60% of doctors based on pre-COVID ordering levels. When you look back at them over time, they continue to ramp throughout the COVID pandemic. In fact, in the second quarter, the order rates are the highest of event, that group is driving the growth. And these are the physicians who had not previously fully adopted Cologuard where we see a slightly different dynamic is the top 40%. These are the true believers, and they are some of the strongest physicians, their orders are down at an average of about 15%. And why that is because their wellness visit volumes are down probably somewhere in that range. And recall Cologuard is ordered primarily during a wellness visit. One difference between Cologuard and most other diagnostics out there is that Cologuard is ordered for the asymptomatic averages. These are people who think they're healthy; we're trying to help them find cancer early. Typically in diagnostics, you're ordering it as for somebody who's already sick, or they've already been diagnosed with something so Cologuard is unique. The top 40% of doctors, they will come back, this is a temporary dynamic, they'll come back as wellness return and office access improves. So I am confident that will happen where it is happening where our reps can get back in there. This correlation we've talked about for many years, the more times you call a doctor, the more the order that is returning. So we're very optimistic that things open up, Cologuard robust growth will continue.

And your next question comes from the line of Catherine Schulte from Baird.

Hey, guys, thanks for the questions. Towards the beginning of the year, you talked about expecting at least $40 million from 45 to 49 and over $100 million from rescreen. How are those two drivers progressing relative to your expectations? And related to that, I believe we should be getting the technical update for next year's HEDIS measures pretty soon. What are your expectations around 45 to 49? Getting included in those following the USPS PF update, and how big of an impact would that have next year?

Sure. This is Jeff. On rescreening, it's a very exciting opportunity. There's a lot of good news there. I am very confident that we will achieve at least $100 million of revenue this year and for Cologuard. This year, over a million more people become eligible for rescreening. On top of them we're, why we feel so excited if those patients that get a rescreen order comply at a much higher rate, over 10 points higher than the first-time screening. And the team we have dedicated is doing a fantastic job at going out and getting more people retested. Cologuard 45 is off to another very good start, and why this is so exciting. There are 19 million people, ages 45 to 49, essentially, they're all in screen. And we believe Cologuard is the ideal test for that age group. Things are off to a very good start there. In fact, if you compare the initial trajectory of the adoption for that age group, it is pacing above the trajectory that Cologuard had in the 50 and older age group when it was first launched. So things are off to a very good start there. And I am at least expecting $40 million for that age group.

And your next question comes from the line of Dan Arias with Stifel.

Good afternoon, guys, thanks for the questions. Kevin or Jeff, I know the situation is fluid. And so confidence around a number is certainly not 100%. But can you just give us a sense of how in your mind you're thinking about salesforce activity and the rebound just through the end of the year when it comes to the screening outlook? I mean you are assuming that you're back to three quarters strength by 3Q or by year end? I mean what's the base case right now?

I don't believe we'll reach that level before the end of the year, as we're seeing a setback with the recent increase in COVID cases. We anticipate that this trend will continue, similar to what we have experienced in the past. Offices are likely to remain cautious, and we don't have more insight into the situation than what you may have. This is a critical factor for long-term growth. Additionally, it's important to remember that 45 million Americans haven't been screened yet. Cologuard is an excellent solution to address this backlog, especially for the 45 to 49 age group. When things begin to reopen, we expect our growth to accelerate beyond its current rate. Although we lack clear visibility on how offices will reopen, our consistent message has been to encourage vaccination. This message extends to our employees and their families as well. Once vaccinations are more widespread, we will all be in a better situation.

And your next question comes from the line of Vijay Kumar with Evercore ISI.

Hey, guys, thanks for taking my question. Jeff, one on the guidance here. If I understood you correctly, the $12 million reduction in the quarter that's just under the reimbursements side right, one-off, ex which revenues would have been basically in place, your volumes were pretty strong in the quarter. So I don't understand I guess the back half, when you are saying there's another $30 million reduction. Is that a reimbursement issue or you're just being cautious on the volume side of the equation?

Thanks Vijay. The overall guidance adjustment of $25 million, half that is related to the $12 million one-time adjustment in Q2. The other half, call it about $13 million, is based on our updated look at the back half of the year. So what Kevin just talked about, salesforce access out in the field and wellness visits, given the recent spike in COVID cases, things are not improving at the pace we had previously expected, so we continue to expect growth in the back half. Just we don't expect as much growth as previously based on this recent spike in COVID.

Next question comes from the line of Andrew Cooper from Raymond James.

Hi everyone. Thanks for the question. Maybe just to take a little bit different angle on some of the same topics, the Precision Oncology space was strong, you talked about Oncotype DX breast. And a lot of that volume comes from screenings that needed to occur, kind of flowing through the pipeline. So maybe just walk us through why is it that business is coming back stronger versus you're getting more cautious on the screening side? Is there a timing dynamic we should be thinking about in terms of just flowing through that funnel or anything else we should think about in terms of why one, working through the backlog might be happening a little bit faster, and one, maybe a little bit slower in terms of getting back into the wellness swing I think.

Yes, this is Jeff. There are different businesses, the Precision Oncology business is more heavily dependent on mammograms, which are largely back to normal and did return to normal earlier in the year. So that's a different dynamic. Also, you have the fact that around 40% of breast cancer diagnoses in this country started at home through a self-exam or pain, which is different than colon cancer. Colon cancer overall is still muted in this country, it has been and so that's the backlog Kevin referenced continues to grow. Cologuard is a solution here. Cologuard has been growing year-on-year since June of a year ago. So Cologuard is helping address this problem. But it is a different animal. The headwinds that we are up against in Cologuard are wellness visit decline and salesforce access decline again, both temporary that seem to do a nice job overcoming those.

And I think this is Kevin, I think it really highlights the strength of the Oncotype DX brand for somebody who has been diagnosed with early-stage breast cancer, a friend of mine was recently diagnosed with early-stage breast cancer and Oncotype was just automatically ordered in that case by the surgeon. And it's different because that patient who was diagnosed versus an onscreen healthy patient, many of whom are going back into a physician's office. And we think that we are being greatly realistic about those two dynamics, offices opening, and patients' willingness to go back into a primary care setting, and especially older patients, which comprise a significant percentage of our screening population.

And your next question comes from the line of Matt Sykes from Goldman Sachs.

Yes. Thanks very much for the question. This on the Pfizer salesforce, they've been a little bit more conservative in the past about returning back to the field is that, are they still back deployed? And if we get resurgence may they pull back? And then secondly, are you seeing any correlation? And originally, there have been a lot of differences in terms of vaccination rates? Do you see any correlation between access to doctors' offices and wellness visits in areas that have higher rates of vaccination, so we can kind of extrapolate that as we see vaccination rates rise.

Our partner Pfizer has been our great partner; they have an amazing field force with an average of about 14 years of experience in a primary care setting. They've been an amazing partner; they did come back to the field in late May. Truthfully, that's later than we would have hoped. But we understand every company has to make their own decisions. And that certainly is the dynamic because it takes time for them to then have that impact on people whose tests get completed, there's obviously a lag between the time the test is ordered and the time that a test is completed. Pfizer helps us reach more physicians. And we're always evaluating ways to make that partnership better and stronger. And we think that their team will deliver good results this year.

Matt, this is Jeff. I'll address the other part of the question regarding vaccination rates and their impact. The relationship really hinges on areas with high vaccination rates, where we see a reduction in new cases being diagnosed. Throughout the pandemic, we've observed the emergence of hotspots. This is linked to changes in behavior; for instance, physicians are more cautious about allowing sales representatives into their offices, and they are also more careful about going out for wellness visits themselves. If someone feels healthy, they are less inclined to seek out a physical exam during a COVID spike. Therefore, there is a significant connection between vaccination rates and COVID, as well as our ability to engage with doctors.

And your next question comes from the line of Patrick Donnelly from Citi.

Thanks guys. Maybe just following up on an earlier one, Jeff, on the rescreening opportunity, can you just talk about how momentum is building there, how you've refined your message to increase kind of a capture compliance rate there and keep it as close to the three-year mark as possible? And then secondarily, just on electronic ordering, how you're progressing there, and again, trying to push volumes in that direction.

Patrick, I've never been more excited about rescreening. This is a hugely important part of our business. Our goal is to get more people screened, and keep them screened over the course of their lives. And we are getting more successful, really, by the weekend doing just that. As you know, over 600,000 more people become eligible this year. So it's something we've invested in and we're seeing improvement. And what it boils down to is that when a patient gets their rescreen order, they comply at a very, very high rate for our communication with patients has been exceptional. Where we've seen even more improvement as of late is our communication to physicians. The goal here is to make rescreening or reordering, if you will, automatic; you want to make it exceptionally easy for physician to identify who needs to be tested again, and for them to place that repeat order. So that's where the effort has been. And I'm really proud of what this team has accomplished. There's even more in store. With next year, over a million more people becoming eligible, this team is going to get it right. And we're also seeing the time after they become eligible, the time to them actually completed the test is improving. So there's a lot of good news to report on rescreening.

And your next question comes from the line of Dan Leonard with Wells Fargo.

Great, thank you. Just two quick ones for me. One, Jeff, would you say that your guidance is de-risked at this point? If we were to have a real flu season in the fourth quarter as it looks like we might? Or is that still something which could impact access? And then secondarily how sensitive do you think your clinical trial and clinical research timelines would be to the current case rates? Are you able to manage with the current infection rates? Are you envisioning that there's some correlation between case rates and your ability to enroll in your studies? Thank you.

Dan, on the first one, guidance speaks and everything we know as of today, clearly in the middle of a pandemic with more hesitates than we could probably count right now. There's a lot of uncertainty out there. So we've created everything we know now. I can't predict what's going to happen with flu or COVID months from now. So we are facing everything that's out there in the news that you and I can both see. On the case rates, those can impact enrollment. You recall last year, as we were trying to enroll our BLUE-C study, which again is for Cologuard 2.0, and a colon blood product we did pause BLUE-C for about five months last year, because of this massive spike in cases. So it can impact, and if we do see a big spike, it will continue to impact enrollments and some of our case studies.

And your next question comes from the line of Mark Massaro from BTIG.

Hey, guys, thanks for taking the question. I wanted to ask maybe a two-parter, I guess. The first is obviously, there's a lot of investor interest in the MRD space. You acquired via Ashion some extra test. I'm curious how that integration is going. I believe you're trying to merge that into the TARDIS technology. And so I guess, can you maybe comment about the timing of data, or potential submission to Moldex? And then another question I had is, can you just over the years, you've been looking at a lot of assets last two years, you've been pretty highly acquisitive, can you just give us a sense for bids dove and just looking at other assets would be super helpful. Thanks.

Sure, thanks Mark. So with minimum residual disease testing, we are focused on delivering the very best test for patients and we love how we're positioned from a scientific expertise and technology standpoint, the combination of Ashion and the TARDIS technology with the proven evidence generation capability and the deep commercial relationships that we exist. So the next steps then would be to optimize the test, generate validation data, prepared to make that test available to patients. It's a natural fit with our breast cancer capabilities, Oncotype DX; we're seeing about half of all breast cancer patients' tissue samples, the tumor-informed approach, it starts with that tissue. The deep relationships we have with oncologists. And then TARDIS, so TARDIS is a really powerful targeted sequencing chemistry. And we believe it'll allow us to achieve the highest level of sensitivity without sacrificing specificity. And then as Ashion has its proven ability to do this difficult sequencing, it's not just the sequencing capabilities, it's the bioinformatics and this is a well-oiled machine. Our partnership with City of Hope and other teams around the country are important. And we have already signed partnerships relating to multiple studies to prove out the capability that we have with TARDIS and Ashion, it's important, it's about a $15 billion total available market. And today, the class is less than 1% penetrated; it's going to change the way that cancer is treated, is after treatment. And we plan to play a very important role in how these technologies are adopted, both in the US and globally.

And your next question comes from the line of Jack Meehan from Nephron Research.

Thank you. Good afternoon, I was hoping you could give us some updates on Oncotype MAP, whether covered lives, and how much revenue MAP contributed, you have to do may launch. And then also, I know it's going through the code pricing process. Now at CMS, any sort of bogey, you're thinking about where that can shake out in terms of pricing?

Jack, this is Jeff, I'll take that one. Oncotype MAP is off to a very, very good start, you'll recall that the two key differentiators for that product are one the turnaround time, the majority of our tests are reported result within three to five working days, so a very quick turnaround time. And the sample input requirement for the test is very low, which allows us to report a result out on a very high percent of patients. You think about the average person who uses this test, they have late-stage cancer, they need an accurate result quickly, and we can help play a very important role in that decision. Coverage is off to a very good start here, we've had multiple large payers started covering the test. It is also covered by Medicare already. This really speaks to the power of the Exact Sciences platform here. We've got deeper relationships with payers, when you think about the Cologuard business, Oncotype DX breast, prostate, and now MAP, the broad and deep relationships we have that allow us to achieve a high level of coverage as we bring new products to market. So things are off to a very good start with MAP. In the May timeframe that has not been launched to the entire Precision Oncology salesforce, for about 100 reps. As Kevin talked in his remarks, these are very experienced reps, and they are hungry for new products. So I know this team is going to do a very good job in launching that test.

And your next question comes from the line of Puneet Souda from SVB Leerink.

Great. Thanks. And Kevin and Jeff, two parts question here. I think you're saying that there are obviously a number of drivers and we all recognize that. I mean, the first 45-year-old coming into the next three years rescreens, there is electronic ordering, there is greater recognition for Cologuard so but despite all that the rep access is low and I appreciate your details on the lowering of the guidance in the second half for Cologuard. But we're seeing that sure there is some hesitancy for the oncology reps to enter clinics because there are these patients are immunocompromised, but primary care practices are just trying to open more broadly. They're trying to get back to normal. And Jeff I think talked about maybe I think it's a last call that you are heading closer to, in a sort of 50% sales reps are doing in person. So just trying to understand if you play that out, maybe the second half doesn't recover 100% maybe it gets to 70% to 80%. But and I appreciate your survey, and I appreciate the Delta variants are so out there, but why access to primary care practices would continue to sort of decline in the second half? And then just a quick clarification on the clinical data for the blood-based CRC?

Let's address this step by step. To clarify, we are not anticipating access declines in the second half; it's not increasing at the expected rate, mainly due to the ongoing pandemic situation.

Correct, and Puneet, I think to put some numbers behind it. The data we had set it on prior calls was the total number of face-to-face details in primary care. That did improve modestly during the second quarter, to Kevin's point I expected to improve in the back half of the year. This is with the rise in Delta, and this huge spike in case counts. What we're seeing just for their own data, I don't expect you to improve as much as we previously thought.

And your next question comes from the line of Alex Nowak from Craig-Hallum.

Hey, good afternoon, everyone. Just a follow-up to Puneet's question there just on the case control data for CRC blood. Kevin, you said in the prepared remarks, it's going to be an initial work. That label initially seemed to be new around the case control data. So am I right there? And if not, does this look like the business support the ultimately the FDA approval and reimbursement of that test, so do you need more data do you think?

We are excited about the opportunity with CRC blood. As we have mentioned before, we believe that the test we’ve developed with the curated methylation panel, along with potentially other undisclosed marker classes, will exhibit sensitivity and specificity that meets or exceeds what has been publicly shared by others. We haven’t had to present our data yet, and when I say initial, I refer to its introduction to the public. We think this data will support our ongoing progress with the BLUE-C study, leading to FDA approval and the availability of the test. It’s also worth discussing how we see our blood test fitting into the broader landscape of colon cancer screening options. Currently, the two best methods for screening for colon cancer are colonoscopy and Cologuard because early detection is critical. Both colonoscopy and Cologuard have shown around 95% sensitivity and 94% sensitivity for stages one and two, respectively, setting a high bar for blood tests. No one has demonstrated anything close to that. If you or a loved one are considering colon cancer screening, ask for the most sensitive test. We believe that Cologuard, especially Cologuard 2.0, will establish a new standard for non-invasive colon cancer screening, with an ease of use that surpasses that of a blood draw. There’s a notion out there that blood tests could change the game; however, the data does not currently support that from either a sensitivity, specificity, or ease of use perspective. Therefore, we still believe that if you are going to get screened, it should be either with Cologuard or colonoscopy, and you should not be asking for the FIT test or any available blood test today. I hope that provides clarity not just to your question but also to a question you may not have asked.

And your last question comes from the line of Kyle Mikson from Canaccord Genuity.

Thanks. Hi, guys, thanks for taking the questions. So on this $13 million headwind in the second half, in your opinion, is that weighted more towards the wellness visit or I guess salesforce access, just wanting to know, kind of perceive those factors going forward? And you would also like similarly, rank order, maybe some of the drivers upside that give you some more optimism, whether that's epic or rescreening, etc. That'd be helpful. And I just want to timing question on the MRD clinical validation data, is there any time you could kind of tell us better understand that as well. Thank you.

This is Jeff. ON the $13 million, if you think of the two pandemic-related factors, salesforce access and wellness as it's both are very important here. I want to make that clear. If you look at the where we are relative to pre-pandemic levels, salesforce access is far more impacted. Still 55% of primary care doctors we surveyed say they're not allowing primary care reps into their offices. So that one's much farther from where it would have been; wellness visits are back to call it 80% to 90% of pre-pandemic levels. As far as MRD data timing, I think it was one of them. The timing of that at some point next year, we haven't been more specific than that. But next year very good progress being made in MRD. As far as growth drivers, I mean look, the beauty of this model is that for screening, there's many growth drivers out there. There are 45 million people today who need to be screened. That's a big opportunity. Salesforce is always one of the top drivers in healthcare for us. I think it certainly is. And that's why getting the reps back out there in front of physicians is so important. For three-year rescreening, this year, I've guided to at least $100 million. So that's another really big one longer-term rescreen becomes, I would think at least half of our revenue. So that will be a big driver for many years to come. Electronic ordering, we were up five points year-to-date, that's a nice tailwind and we continue to expect at least 50% of Cologuard orders to be electronic by year-end. So these factors are all very important. And they actually work together, so it's hard to say which one's the most important, but they're all important together. I do want to clear up one thing I said in my remarks, guidance for COVID testing for the year is $75 million to $80 million. I think in my remarks he said $75 million to $85 million. We're looking for $75 million to $80 million.

And this concludes today's conference call. Thank you all for participating. You may now all disconnect.