Exact Sciences Corporation (EXAS) Earnings Call Transcript & Summary

Thank you, Kevin, for that lovely overview. Good morning, everyone. And as Kevin said, welcome to our Seventh Annual Gabelli Funds Columbia Business School Healthcare Symposium. My name is Carri Chan, and I am the Faculty Director of the Health Care and Pharmaceutical Management Program. at Columbia Business School. The goal of our program is to educate, support and build community for our students and alumni who are interested in the various facets of the health care sector. Our students are bright, ambitious and eager to make a big impact as they embark on their careers. Today's event is a wonderful opportunity for them to learn from industry leaders who are pushing the forefront in health care. It is also an opportunity for our students to reconnect with so many of our alumni and industry friends that are here. It's wonderful to see so many of you in the audience, I'm looking forward to reconnecting with all of you. You are a testament to the strength and longevity of our community. If you are interested in getting more involved with the Health Care Pharmaceutical Management Program at CBS, as a speaker, a mentor or generally to support our students, please make sure to be in touch. I want to extend our deepest gratitude to Mario Gabelli and the entire Gabelli Funds team for their continued partnership in making this symposium a reality. On behalf of our students and the health care program at CBS, we are so fortunate to have your consistent and enthusiastic support and engagement. This year, we have a really exciting lineup of speakers and topics. I want to thank all of our speakers for being here. The goal is to spark discussion, so I encourage all of you to engage when we have the opportunity for Q&A and in the breaks in between. Let's make the most of this opportunity to learn from each other and contribute to the advancement of health care. So with that, I'm going to invite up the speakers for our first panel on multi-cancer early detection. So first, maybe Asia, I'm going to just point you to the first seat Asia Chang, VP and General Manager of Oncology Quest Diagnostics, David Harding, Pipeline Product Management at Exact Sciences, Noam Krantz, SVP of Corporate Development at Guardant Health; and Alexis Tosti, VP, Strategy, Corporate Development at GRAIL. So thank you to all of you for being here.

And so to take this off, we've all heard the data showing that early onset cancers, diagnosis and people under the age of 50 have been increasing over the past decade. This is particularly true in gastrointestinal cancers, including colorectal cancer. At the same time, cancer may be a decade -- 2 decades ago was often seen as a death sentence. But advances in treatment and technology have really shifted it more towards, in many cases, a curable condition or into something that's more considered chronic disease that needs to be managed over time. And the key to that, it really is early detection. And so it's really wonderful to be here today with all of you speaking about kind of how do we shift to earlier detection. And how do we think about multi-cancer early detection and really helping move the paradigm forward. So today's panelists brings together a team of experts across multiple different organizations who are trying to address this. So perhaps to get us started. You are all approaching multi-cancer early detection in different ways at your organization. If you could each briefly describe and give to the audience a summary of how your organization is approaching NSAD and how it fits into your overall organization's strategy, and we'll start with you, Asia and go down the line.

All right. Great. Thanks for the opportunity. So I think at Quest, 1 of the -- there are 3 dimensions that we tend to think about this for early cancer detection. I think the first piece is actually around access to the innovation. I think Quest really is the definition of access across our health care ecosystem, whether that's connectivity to different health care systems and health systems, clinicians, when you think about your typical blood draw, that's things -- those are things that Quest naturally brings to the table. And I think our relationships with each of these amazing innovative companies really enables that access. The other piece is actually thinking about access as an innovative dimension as well. And so I think that's the other element that at Quest, we're thinking whether that's on the technology side or even on the testing side and I'll share more about our approach there with -- on the testing side. And then certainly, it is also thinking about whole health and wellness because cancer is an important part of what people are typically concerned about with health care but so is cardiac disease. So is brain health. So as all these other dimensions, no primary care physician just thinks about cancer, they're thinking about whole health. And people in general are always thinking about that as well.

Great. Thank you. David?

Yes, at Exact Sciences, good morning, everybody. Our mission is to prevent cancer, detect it earlier and optimize treatment when folks do indeed get cancer and so as we think about our flagship product, Cologuard, which is focused in the colorectal cancer space, we say, that's not enough, right? Just optimizing for colorectal cancer is not going to get us to our mission of eradicating cancer across many types. And so from the very beginning, we have had this vision that once we get colorectal cancer squared away, let's then move on to multiple cancers and so we view it as highly, highly complementary for us to not only focus on colorectal cancer and other product lines, but then to expand that into multi-cancer early detection, right? That's the only way we're going to get to that ultimate goal of eradicating cancer.

Good morning, everybody, I am Noam Krantz from Guardant Health. So at Guardant our mission is to conquer cancer with data. We've been doing that now for about 12 years. And we play really across the continuum of care in cancer, all the way from late-stage therapy selection, to MRD to screening and early stage detection. When you think about cancer, it's the 1 kind of disease state where prevention is not preventing people from getting it but just catching it early. And that really plays into this common theme that we have in our approach. And so the way we look at all of these areas of cancer is we have 1 sort of common tech stack that can be used and changed in different ways to get to different indications and different stages of cancer depending on kind of availability of our ability to catch it in blood, and that's really our founding is being able to detect blood. When we look at early stage cancer, the question -- and each 1 -- so we're looking at all of these different kind of indications of cancer and the different stages, and each 1 of them requires a different approach and screening, of course, completely different because it's harder to catch, from our perspective, we want to understand each 1 of these indications, how to go at each of them, so we're going after first with colorectal cancer. We see that there's a huge need there. And then on top of that, adding an MSA related to that and then different indications.

Alexis from GRAIL. I think GRAIL's unique in that we were founded based on incidental finding at Illumina about 10 years ago, where cancer or a weird signal was detected in some blood samples, and it turns out it was reflective of cancer. And so we were really founded with the intention of being able to build blood tests that we're able to detect cancer. And so that's kind of been our mission from the beginning. And we're almost 10 years in. We've launched a product a few years ago called Gallery, which is a multi-cancer early detection product capable of detecting up to about 50 cancers in the blood.

Great. So Alexis, maybe we can expand a little bit more, GRAIL, as you noted, from the beginning has really positioned itself as a company, as an innovator, addressing the challenges of multi-cancer screening. So in your view, what are some of the advantages and disadvantage, do you think that this approach is kind of trying to do all together and that being your north star has brought? .

Yes. I think it's important to understand kind of the derivation of that. So when GRAIL was founded based on this incidental finding, we set off to determine, okay, how do we build the best technology here. And we did a discovery study where we hinted a number of technologies head-to-head against each other to identify really what would be the best approach to doing this. . And when we did that, we actually found that there was a shared signal that we were finding. So we were not finding a signal for colorectal cancer or a signal for lung cancer, a signal for breast cancer and adding them together, we are finding a signal shared across cancers and then we were able to add kind of an additional portion to that test to differentiate where that signal might be coming from. And so we didn't really have a choice to go cancer right cancer or multicancer, we -- the technology is a multi-cancer test. And so the 1 challenge there is that's not how screening is done today. So it really is an evolution of how you would approach screening in the market, and it takes a lot of education, and we're focused on that.

Great. I think maybe no, we can go to you. In contrast, right? So your Shield Trust was first launched, as you noted, specifically for colorectal cancer. Now you're in the midst of a trial to see for detecting multiple cancers. And so can maybe share it's like kind of the opposite approach like has taken and how kind of illuminate in that contract?

I mean it's the opposite, but it's also kind of similar. So we have Shield, which was launched a little bit over a year ago. It is on track to be the most successful DX launch outside of COVID. So it's moving along very rapidly. And Shield is a colorectal screening product at this point, right? But at the end of the day, it was developed ultimately to detect all cancers. And so the way we look at it is by indication because you have to -- each 1 of these areas of cancer is its own little world of access, reimbursements, there are many challenges in each area from a detection perspective, from an access perspective, reimbursement payers, all that type of stuff. So our approach was to go at an area that we saw a significant unmet need. And first, that was colorectal screening. And the reason is because this is an area where early detection is key. You can have a really big effect on patients. It's a growing area, especially in younger patients. And it's an area that compliance is an issue. So nobody wants to go in and get colonoscopy, even the stool tests today have a fair amount of falloff in compliance our test so far has shown that I think sometime around 90% of the tests that we've done are in patients that have never been screened before. And in the hospital setting and different practices that we've looked at, there's about 2 -- just by offering Shield, there's about 2x the amount of screening that occurs in those offices. So it's having a significant impact, then what we've done is we're going after lung as a specific indication. And then you may have seen, if you haven't seen our Investor Day a couple of weeks ago, we talked a lot about multi-cancer screening. Our approach to start a multi-cancer screening, as I said before, conquering cancer with data. It's really more on the data side at this point. We're trying to understand how to go at it responsibly. We're talking to the government authorities. We're participating in the NCI Vanguard study. But we're also building a ton of real-world evidence kind of on the backs of our colorectal cancer screening product, where we're allowing physicians to opt in to the MSA and patients to opt into allowing their medical records to be shared, we will actually share the MSET data that we're seeing coincidentally with our tech stack. So it's really on that data side at that point. We're trying to understand you want to give this access to patients and physicians to understand what's going on in their DNA and their body and their epigenetics, but you don't want it to be kind of a time bomb as far as expense and all that to the system.

Great. And I think, David, from the outside, it might seem that Exact and Guardant have a similar path in our approach in the sense that you're Exact Sciences is synonymous with your high adherence at home, colorectal brand. And so you're now starting to expand into multi-cancer screening and so how do you address the fact that people typically associate exact with the Cologuard system and don't get product confusion as you're entering into kind of a broader scope of testing.

Yes, it's an interesting question. So first of all, we're very proud of Cologuard. We've screened over 20 million people now with Cologuard and have really bent the survival curves in a very good way. So we're super proud of that. Obviously, the brand is extremely strong, and it's very trusted in the primary care community and among consumers. And so we really believe that we can build off of that. And it's really important to note, I think, that when you have a standard of care screening approach like Cologuard or colonoscopy, or mammography or the other standard of care screening approaches, those are there for a reason. It's because they work. And what we're trying to do is say multi-cancer early detection is complementary to those standard of care screening approaches, right? So with the Cologuard, right, you're going to get very high sensitivity, very good precancer detection. And you don't want to stop doing that, right? That is the best approach for detecting colorectal cancer. For other organ types, multi-cancer early detection is the only way you can interrogate that organ, so what we're saying is, let's make it complementary, right? If you're getting your mammogram, great, keep doing that because multi-cancer early detection is not going to do a particularly good job of detecting breast cancer. Similarly, with colorectal, use the Cologuard test, use other tests that are interrogating that organ directly for other organs that you can't interrogate directly use a blood-based test. So we believe it's very, very complementary. We believe that the strength of the brand and the trust that we have at Exact Sciences with primary care physicians and with consumers is going to build on that with our Cancer Guard test. So again, just integrating it seamlessly with our sales teams with all of our infrastructure that we built with health care systems is going to be really, really important to success in getting adoption.

Right. I think the good news for everybody in society is that there are so many people who are working in different types of solutions and different approaches to this. And so this brings to you, Asia, you have a number of us has partnerships with a number of these organizations of your fellow panelists, with all of them. you're also developing your own multi-cancer risk with MD Anderson. And so how do you manage the potential channel conflict and competition between all of these different offerings in your portfolio with your partnerships, and how would you position your in-house test relative to these established partners tests that you have?

Yes. That's a great question. I think I think outside looking in, I can naturally see how that question arises, but I think as you heard from each of them, that the positioning for each test is actually quite unique. And I think the level of evidence within different populations is also quite, in many cases, complementary. And ultimately, why we have these partnerships is, again, if I bring it back to the access piece is it's giving the market and consumers, clinicians, the power choice because the fact is screening is a programmatic strategy. It's not a single time point. . It is a series of things that have to happen in our health care system to make it an effective and adoptable and broadly used solution. And so that access enables each of the partners develop their own evidence strategies, position it appropriately for clinicians. And I think that's an important part of Quest's role. The other aspect is about I think of it as innovative access. And so with our own partnership with MD Anderson, I will say that it's shaped by my own personal experiences around looking at a lot of the data, whether that's the GRAIL data, the SHIELD data, the cancer guard data. It's really interesting. And I think you brought this up Carri around evolving cancer to be thought of as more chronic I actually think that's a really important insight. And it actually starts right at the screening stage because most times, we tend to think of cancer as episodic I'm finding something. I'm finding something. I'm finding I'm detecting something. You're detecting it as if you're catching a virus. But we actually know cancer doesn't work like that. It grows in your body. It evolves in your body, it hides. That's why it's actually really difficult to identify those signals. And so our partnership with MD Anderson really builds upon that insight. It's a circulating tumor protein assay, and it's intended to identify cancer risk. People that have signal that there are growing tumors in your body are giving off signal. There's an inherent risk associated with that, not unlike any type of cardiac disease, not unlike any metabolic disease. And so part of that is helping the general population, helping people understand who actually is at risk and should be more proactively screened. Right now, the only methods for that are you over the age of X, are you this gender. There's more to it than just the gender and age. Risk is actually inherently biological and so we think these protein tumor markers really complement and in a lot of ways, could unlock the market and accelerate the use of appropriate technologies along the continuum. It's really a longer continuum.

Great. So I think maybe building on the theme of partnerships, as we noted, Quest is partnered with all 3 of you. But all 3 of you also have various other types of partnerships with pharma, with service providers. And so with payers, so we'd love to learn a little bit more about how you think about such partnerships. What are you looking for in a partner? And how much of that is contingent on what's currently in your pipeline versus what you see coming down later in the future. So maybe we'll start with you, David.

Yes. First of all, thank you to our friends at Quest for being an important partner in blood collection, right? And I think what it all comes down to is, we need to make this easy for consumers and for health care providers and for health systems and ultimately for payers. What we found in our experience with Cologuard is the more we make it convenient and easy for consumers and their clinicians, the better compliance we're going to have. Noam talked about that a little bit earlier. But having that experience, having that ability to reach out and manage the consumer through that whole process is really, really important, right? We find too many areas where if there is a barrier to screening then people will fall out of the process. And ultimately, we want to get as many people screened as possible. So what does that mean for our partners? For partners like Quest and Asia who are providing that service right, we want to make it super convenient for a consumer to be able to go and get their blood drawn, right, and be able to schedule something that works with their day and in their life style. Secondly, with our primary care providers, right, we want to make sure that, that experience from ordering to resulting to then working up a positive patient is as easy as possible, right? We all know primary care, health care systems are overburdened, and we want to make that process easy. So providing a very easy diagnostic resolution pathway, providing a very straightforward interface being able to order straight out of your EHR system, all of those are exceptionally important. And then with the health care system, being able to publicize the fact that early cancer detection is available is really important. We think about it as kind of this 3-legged stool. You got to educate the consumer to create demand for this product and create awareness. You have to educate the primary care physician so that they can actually order it and speak to it when a consumer comes and shows up and says, "Hey, I want this thing." And then you have to have a great partnership with the health system to work up those positive cases on the back end. And all of those partnership things, right, are enabled by electronic connectivity, good awareness-building campaigns and educational campaigns and then ultimately a straightforward diagnostic workup process that is really important.

Yes, I'm next. So at Guardant, we're tech dev people at the end of the day. And I would say that we're completely obsessed with the idea that we can take a vial of blood and find cancer, right? And so we're trying to do that in some cancers that are easy to catch, which is colorectal cancer probably 1 of the easier ones for some reason, it sheds the DNA, the epigenetic biomarkers are easier to find than some other cancers that don't shed quite as much. And so we've done, I think, 20, 30, 40 pilots with other companies to understand how we can do that better. So we can't really -- we have to go out to the external environment because there are so many different ways and different possibilities to detect all of the different types of cancer. So from a tech dev perspective, I think partnerships are really, really critical. We want to tap into smart people. We think at the end of the day, it's the intelligence of the company and the ability to be able to run these pilots. That's a really significant advantage for us. But it's also just that will and that kind of obsession and that desire to be able to find all of this in blood and then to drive it to an approvable and reimbursable product at the end with the data behind it and then comes this big lift of trying to get access and breaking down those access barriers in the U.S. outside the U.S., every market is super, super hard. You have to get the approval, you have to get the reimbursement because they're expensive test to run for us, let alone for the customer and the patient in the end. So that's where the quest. I think we're all grateful to Quest for this, I don't know, what is it like 600,000 CPs that you guys have access to 8,000 different phlebotomists centers around the country that they have -- that they own essentially. So it's -- for us, it's really amazing to have that partnership as well and to be able to accelerate once we've done.

Yes. And I think these guys have pretty much covered both stakeholder partnerships and development partnerships. And I think those are both critically important to us as well. So as we were developing test. And as we continue to look into future development, research partnerships are important to us. And we're also really focused on stakeholder partnerships. So as David was describing, just enabling navigation through the health care system is incredibly important. It's a very complex system. And so partnerships with Asia and with a number of others, really help enable that access.

Great. So everybody keeps referring that to you and so maybe we can just build on that a little bit. And clearly, what Quest has this major advantage of having an immensely vast network. I think gave us a few statistics about that. That not only is across the entire geography, but really is directly integrated into patient services. And so I would love to learn a little bit more about how you think about leveraging this infrastructure, particularly you mentioned primary care to move on just the traditional cancer screening adherence rates that are not great. People don't necessarily be get anxious when they need to get their colonoscopy and other types of screening so that we can ensure that patients actually get the follow-up diagnostic tests, after they do these initial screenings, right? So how do you go once you have those positive signals follow-up in nature that the patients get fully diagnosed and then get the care that they need.

Yes. Great question. I mean I think elements, those statistics like something 650,000 clinicians connected 6,000 in-office phlebotomists, 2,000 patient service centers. We have a huge courier fleet that ensures any lab ordered through those channels, makes it to a hub within a day. That's why your CBC is can be turned around in less than 24 hours in some cases, that infrastructure is vast and the investments and the capital to support that has been made over a tremendous amount of time, and that's something that Quest continues to invest in across that -- our own technology stack. That's kind of what I mean a little bit about innovative access as well. We recently also have partnered with Epic to look at our entire infrastructure so that we can become even more integrated with health care, and that's a long-term vision that our CEO, Jim Davis had. And so I think those are examples where when I think about that connectivity we're continuing to think about that. And then the other piece that you're bringing up around adherence and bringing people through the care paradigm, I actually think this kind of brings it back a little bit to even just my our partnership with MD Anderson, along with, frankly, other diagnostic tests, I think of them as risk triage tests because I think what we're hearing and what you're -- what each of the partners could acknowledge is that different cancers have different issues related to how people follow through. In certain cases, if you take PSA, as an example, PSAs like wax and wane in terms of its use. And the reason it's wax and wane is because initially people caught thinking, "Oh, this is the thing that will detect prostate cancer." It's not really the perfect test detect prostate cancer, but it does tell you a certain level of risk. And so once you have some profile to understand that this person is at risk, there's actually additional triage tests that need to be deployed so that care providers and patients can have a shared decision-making on what the appropriate next step looks like. So there's actually types of testing and types of information that helps people get comfortable and move through that care journey more effectively and more efficiently in different cancers will have different requirements. So I suspect even when the multicancer test, there will be follow-on tests and other aspects that actually help people understand what's next. And there's probably testing that needs to be done before that to help people understand, yes, you are an appropriate person to get this type of test. I think that's what generally speaking, 1 of the challenges with this is a population health problem. And so there's a resource problem that comes into the overarching health care economy and ecosystem. And that's a really important role for Quest to play in, and we have partners and technology investments and innovative access that we think about that spread across that continuum.

Right? I love how you're kind of describing the potential impact that this could have on changing just the diagnosis journey of an individual, but also that next, so how is this going to potentially impact cancer care, right? We've seen shifts towards more outpatient follow-up less invasive types of procedures. And so I'd love to hear from our panelists before we open it up to the audience, how your organization is thinking about how MSAD could actually transform the way that cancer care is being delivered. So maybe we'll start with Alexis and then we can see how others are thinking about this.

Yes. I mean, I think the vision is that with multi-cancer early detection, you be able to detect more cancers earlier. And so ultimately, instead of treating late-stage cancer, you're going to be able to treat earlier stage cancer where those treatments can be more effective and more likely to be to cure.

Right. .

It's a hard question. It's not a lot about it in the last couple of weeks since we've been talking about this on the side. Like I said, it's a strange disease state and that prevention is just catching it early. So there's that possible burden of people knowing that they have a cancer they know potentially maybe where it's coming from and then you need to find out where it is you need to remove it, right? Or you need to do some type of immunotherapy or whatever it takes. . So obviously, the fear is that you kind of shine a light on the issue and then in each patient and then you have to solve that through some type of further diagnostics and then treatments, and that's expensive. But I think at the end of the day, the earlier you catch it cheaper it is to deal with it, obviously. I think those late-stage patients are extremely expensive to the system. So I think that as we progress and advance studies and some of the studies that we're doing with the authorities that will actually track some of this data, I think you'll see that there's significant savings to the system in the end.

At Exact, we ran a health economic model. We took a simulated group of 5 million Americans between the ages of 50 and 84, we looked at them over a 10-year period and modeled out all the different potential cancer incidences and things like that. And we said, okay, that's great. We have this model. If we apply to that not only your standard of care screening, but also a multi-cancer early detection protocol, and we have these people getting tested annually over a course of 10 years. What's the difference in outcomes for this only standard of care adherent body versus the group of people that took a multi-cancer early detection test. And I don't think our findings are unique, I think, GRAIL and others have done these types of models as well. But ultimately, what it found was we could reduce Stage 4 cancer incidents by over 40%. And in addition to that, we could reduce overall cancer mortality by 18%. Now when you think about that in comparison to advances in, say, immunotherapy, other treatment approaches. And you model that out over that same 10-year period, you get about a 2% reduction in overall mortality. So all these investments that we see across the industry in advancing therapies and treatments are really, really great. But if that only gets you a 2% improvement in mortality over 10 years, versus detecting it earlier and 18% reduction in mortality, you can see how that makes a massive improvement on human health and reduces cost dramatically, right? What we've modeled is that detecting at Stage 1 or 2 is between 4 and 7x less expensive than detecting at Stage 3 or 4, right? It all is very logical, right? And our host earlier showed that chart that showed health care costs skyrocketing, right? How do you bend that curve in the right way. You do it by catching cancer earlier where a surgical intervention or some other minor intervention is going to work fundamentally much better than years of expensive therapy.

Great. Yes. we've seen this play out in a number of different areas. And I think the key is really this earlier preventative type of shift rather than waiting for the acute episode to be very disastrous. So with that, I'm going to open it up to questions from the audience. I believe we have Mike Runner. So if you raise your hand, someone with the mic will come to you.

I'll kick it off. You just basically answered the question I was going to ask about the cost implications. I'm curious how do all of you work with both insurance companies and the government to make sure that incentives are aligned so that people do take these tests earlier given the obvious payoff not just for consumers, people but also society in lowering those costs.

I'll start. I mean, at Quest, I think, because of the role we play in our health care ecosystem. We have great relationships with many payers and that's spread across all the types of testing that we provide. I think when it comes to certain innovative applications of those tests, that is an area that Quest, I would say, candidly, probably struggles with because the evidence behind it requires meaningful studies that each of these partners provide and that helps people understand where it fits in that ecosystem. And so our role is multifaceted in that enabling that access helps build the right evidence benchmarks but certainly, our existing relationships helps pull that through to the rest of the ecosystem. I will share a little bit of my own soapbox, if you will, that I do think our health care ecosystem is really funny because we tend to put diagnostics in a cost-plus payment structure, if you will, in our health care ecosystem. And when you really think about it, there should be more value that's provided to diagnostics in general because each of those pieces helps you get to the end goal. We've somehow assigned all value to the very last step and that doesn't always make sense to say, "Oh, only the surgery, only the drug should recoup 90% of the value." Every single piece of that journey is incrementally important and so I think there is an evolution that as an economy, as a society we should really think about as a public policy, should think about the value of actually that diagnostic information.

Yes. Yes. I think evidence is certainly crucial, and we're all collectively working on evidence strategies that will demonstrate not only the performance of these tests, but also the clinical utility of them. But we need to ultimately take that to government, right? And there are efforts underway in Congress, all of us support to introduce a multi-cancer early detection bill that will enable Medicare to actually pay for a multi-cancer early detection test. And that's working its way through Congress. We have to work very, very carefully in advocating for that with our partners to get that legislation passed. Otherwise, it's a really tough road to get ultimate reimbursement. But ultimately, it comes down to demonstrating utility. And the more we can collectively produce evidence that shows we're detecting cancers earlier. We're reducing cost of treatment. We're generating really great outcomes for patients, the more we'll have payers adopt.

Yes. I would just -- I would echo that. I mean at the end of the day, the government in this case, I think, is a good partner. And we've had a really good experience with all the different, whether it be Republican or Democrat, and it's been a good experience partnering with the government.

I think there's mics over there.

I'm Henry from Regeneron, we're a biotech with a significant portion of the pipeline in oncology right now. There may be a tailwind emerging where we move to premalignant conditions, precancerous conditions and more aggressive preventive or risk stratification, something you talked about of transforming this into a chronic risk management. . How far out are we in terms of both the diagnostic paradigms as well as the therapeutic prevention as opposed to therapeutic -- or rather the preventive regimen as opposed to the treatment regimens.

I don't know.

I think there are a number of folks looking at that in there, so some essentially early studies looking at where you can identify signals that enable you to better serve those patients, whether it's with treatment or watching or no treatment. So we're early-ish, but it's definitely on people's minds.

Yes. And obviously, with our colorectal cancer test, we are detecting precancers and identifying those and enabling treatment of those. It's a little bit harder on the blood side of things, right, to really identify those precancerous lesions. I'm sure as the technology evolves, we'll get better and better at that. Thus far, at least in our blood-based studies there's not a ton of evidence that we're able to really find precancer just yet, but I imagine that will evolve and improve over time.

I would say too, I mean, I think that this is the partnership and the willingness from different pharma companies given their pipelines to decide where to invest time and energy. But there have been studies done where secondary findings, tertiary findings are -- turns out this anti-inflammatory drug has a statistical differentiation for people with reduced cancer rates. But that's not really surprising when you think about the pathways that cancer develops, so some of that implies there are therapeutic interventions that could be provided more proactively. Those are longer studies, those are trickier to your point to sort of look at. But I think a lot of the technologies underlying that are actually in these companies shop right now. And -- but that requires relationships and partnerships to go explore that space.

I think the other component of it is the real-world evidence you're getting from the biobanks that you can build -- so we have, I think, 1 million patients' worth of blood at this point that can be connected to claims data. It can be connected to EMR data. When you put all that together, apply some AI to it, there's going to be some pretty dramatic findings that are totally coincidental to why you're taking the blood and as you do population screening and you get to the couple of hundred million patients, it's going to be pretty amazing.

Where's the mic?

I was wondering if maybe you could comment specifically on the early diagnosis of pancreatic cancer. This is kind of the general point you're making earlier, David, this is something when it's caught early enough, surgical interventions can be pretty effective. Most of the time, though, it's only caught late and when it's metastatic, half the patients are dead within 9 months. We're making progress on that. We have a drug in Phase II where we actually saw 86% overall survival at 9 months. We announced in September. So we're kind of making progress in the late end, but we would love it if there were more ways to detect it early, so more patients could be eligible for surgery. So anything -- any progress that you guys are seeing in pancreatic cancer early.

Yes. I would say that pancreatic cancer is 1 of those cancers that our technologies detect really well, right? They tend to shed a lot of DNA and protein into the bloodstream. We find that pancreatic cancer is 1 of the highest performers within our multi-cancer early detection test. So the ability to find those cancers pancreatic, ovarian, right, early, I think it's very, very high. And so we're extremely hopeful and we'd love to collaborate with pharmaceutical partners who can then say, "Hey, I've got an early-stage treatment as well." We often run into clinicians that say, Well, what's the use of really detecting pancreatic cancer early because there's no good treatment, right? And we say, "Well, okay, but we got to sort of set foot on the moon before we figure out what we're doing here first, right?" So let's find those cancers early, let's partner up with the therapy companies to really create a comprehensive early detection .

We are finding there are good ways to treat early-stage pancreatic cancer. So some of the critical patient stories that kind of come out of the use of gallery in the real world, and is the name of our multi-cancer early detection test that we found early pancreatic cancers and been able to eliminate cancer in those individuals. So completely cure it, which is fantastic. .

This is kind of like saying a little earlier, like the policymakers have essentially said like USPSTF gave it like a C or D rating to do pancreatic cancer for this exact reason like the there's not a good enough treatment. It's like, well, I'm pretty sure finding the signal is halfway there. We're getting there, like how can we say that like identifying that is not valuable.

My name is George. I'm a physician at CBS graduate, not an oncologist. One of the questions I have, as you start doing more early detection, I'm assuming that a lot of the sensitivities for most of these tests are going to be quite high because I assume the negative predictive value is going to be quite high because the populations are going to have lower prevalence, is 1 of the concerns that payers might have is that these patients are going to require more serial testing over time because an early negative test does not necessarily mean you're not at risk or a cancer down order.

If I understand the question correctly, it's that the negative test does not mean you won't have cancer in the future. Right .

Right. I mean because as you start screening people early on, who are -- where the prevalence is probably going to be quite low, and the negative predictive value of these tests are going to be quite high. Naturally, the sensitivity of these tests should be quite high. So does that really effectively screen people if their likelihood of disease is going to be low at that stage in their lives. .

So the way we think about it is actually -- we've designed the test to have a very high specificity and so you have -- if you have a negative test, we actually recommend annual cadence of screening because cancer can develop over time. So you would get an annual test and tells you at the time, we don't see a signal, but it doesn't mean you don't have cancer, which is why, as David was talking about, we want to make sure that people are using all of the standard of care screening practices.

I would just echo that.

Insurance companies have as payers that they're going to -- for vast amounts of the population are going to be paying for cereal testing every year.

Yes. I mean, they certainly push back on that, right? And we know for every type of cancer screening, whether it's breast or cervical or lung or colorectal, right? That is a net cost adder, generally speaking, to the health care system. But when you look at the value of life years gained, in contrast to that expense, right, we deem it to be worth it as a society to pursue that. So I think, again, the power of cumulatively screening many types of cancers with 1 test really is very powerful, as opposed to trying to do screening with a bunch of other individualized tests, right? So we want to combine that power of combined incidents so that we can get the most economic value. But of course, it is going to cost the health care system to do this. But again, the value of life years gained cumulatively, I think, is going to be exceptionally powerful.

I think we have time for 1 last question. You already have a mic there.

I've heard the word population and prevention, which tends to be the world of public health, health care. Are any of you are currently working? Or do you anticipate any future where the CDC or state or local health departments will become involved in your businesses? Is this a public health question or more health care .

I think we are they already are. The short answer is that they definitely already are. I mean I think the 1 brought up the NCI looking at how these types of studies should be run. It is a population health question. And if I sort of connect some of the ideas that we just brought up around resources and like I think the net benefit elements and the intention for reducing mortality outcomes, stage shifting so that spend gets done earlier with better outcomes are all really important avenues, and I would add that, again, like I think the element -- 1 of the missing elements to this is who is actually symptomatic. Like if the symptom is only 45 and gender, that's actually not a really good like benchmark. That's where I think if I come back to our cancer risk assessment, there are actually known markers out there that point towards cancer risk, whether that's CEA, whether that's PSA is a good example. Like that actually is probably not perfect for detection, but it is important on a dynamic level to understand who's at risk. And we as a society should probably be measuring this on a regular basis, because as you're looking at that and there are very accessible tests, this is where economics comes into play, you actually can help build a better foundation for a lot of these really amazing technologies to build upon. Right now, the foundation is a little bit amorphous because there's only, again, the gender, the age and maybe some rare hereditary condition. And so I think that's an element at play that I think as a group, we should look at this more at as risk, same with A1c, same with your cardiometabolic profile, like it's not any different, to be honest.

All right. With that, I think we are out of time, but thank you so much for having such a wonderful discussion.