Our digital health channels. It's been great to see there, you know, despite some of the NHS headlines, the growth, you know, persisted and so on. Really excited to be there. For the rest of the year, you know, we've announced we're going to implement Epic by the end of the year. We continue to see momentum from some of our other integrations, whether it's Quest or athenahealth. You know, the pull-through's there, so it's great to see.
You mentioned NHS, let's just dive right into that.
Yeah.
That was sort of the big update that happened during the quarter. A lot to parse apart there. You know, has that impacted any of your customer or any of your conversations around demand?
Sort of has it had any impact on the business as you see it in terms of like volume?
I'd say that, you know, the, the headline came out and the, you know, physicians who are orders, physicians who are prospective orders asked more questions. It was pretty clear though that those who saw beyond the headline and saw some of the clinical utility measures such as, you know, stage 4 reduction, increase to stage 1 and 2, decreased emergency room presentations, 4 times more cancers found than the standard of care, like, they got it. You know, that all being said, everyone wants to see the data at ASCO. You know, it's one of those SEC disclosure type things where you've got data in house, you've got to say something vague to not protect your I mean, to not ruin your ASCO presentation.
Everybody wants to see the ASCO data, and that'll be coming out here toward at the end of the month.
Okay. Any way you can frame that? I know it's not, you know, ASCO yet. We are getting the same question.
Any way you can frame it, like what the various scenarios are, what the various outcomes are, and sort of like where it could go from there?
Yeah, I mean, I think you'll see is all the underlying data beyond the headline, right? The qualitative headline. You know, the cancers by stage, how many where they were in each of the years. You know, where we really made what all the details are behind those clinical utility metrics. You know, our field team, we've expanded that. We've expanded our salespeople. We've expanded our medical sales team. They're all being hired and trained up, so by the time ASCO hits, they can hit the ground running with, you know, updated materials, education for physicians and so on. You know, we're excited to finally have the data out there 'cause it really is, you know, this data's never been seen before.
You know, it's a randomized controlled trial of 140,000 people, three tests, you know, over the period of the three years, three time points. You can really see just how our test, how a multi-cancer test can detect cancer, you know, very efficiently when it's sitting alongside standard of care. Standard of care only catches 14% of cancers, so you know, it's, there's a whole lot that people aren't testing for.
Okay. What about going back to NHS, what are the next steps there?
With the NHS?
Yeah.
Yeah. You know, we've got a, we have an agreement with them, right? As part of this whole trial thing, there was a series of clinical utility endpoints to look at, and we've, you know, met some of those. We'll have a discussion. Like anything with NHS or any other government agency, that's always gonna be balance of politics, budget, and data. We'll have those discussions. Those discussions will happen, you know, probably over the next 12 months or so. There's a lot going on with NHS right now. I think they're consolidating the way that they run the NHS with the government.
You know, we do talk to them and of course, we look forward to working with them on, you know, how and if this gets implemented in their population.
Okay. Is there anything that'll come out at ASCO that you think could impact those conversations or?
No. I mean, I think at this point, I believe they have the data. They've, the key people there have been read in. As I said, I think they've got a lot going on outside of our study.
Okay. All right, fair enough. In terms of the NHS data and what you'll present at ASCO and how that impacts, you know, the FDA.
That was a big debate point.
what would be considered. You know, what gives you confidence that that's not gonna be interpreted as an incremental negative?
Yeah
of your data package?
Yeah. We've been in breakthrough with them since 2018. We've designed, you know, our study package for them. We've submitted all that in January of this year. They've accepted the review package, we're in a review process with them now. The part of the NHS Galleri trial that was going to them was the first year data, which was not the primary endpoint, right? It's the performance data, which, you know, we've now repeated in multiple studies, interventional studies, case controlled studies, really something that no one else in the space has done. No one else has interventional data or prospective data. We're, you know, confident that, you know, the package is the package. That's what they're reviewing. You know, could there be an AdCom?
Could there be other people who want to talk about the clinical utility metrics? I'm sure that may happen if you know, we'll see how that goes. What the FDA said they're gonna be looking at are the benefits and harms of the test and the test performance. I think the NHS data, the clinical utility will be more impactful on like CMS or-
Okay
payers.
Okay.
I would say just on that, we also have the REACH study with CMS and FDA, where the primary endpoint of that study is a stage 4 shift, which is kind of what we've shown in the NHS data. We, you know, we have a path there as well.
Okay. All right. Maybe since you mentioned REACH, let's go to that. Can you give us an update on the timing for that, when we can expect the next update there?
Yeah, it's continually enrolling. It's gonna be over 3 years, 3 blood draws for the population. I believe the final readout sometime in early 2031-ish, somewhere in there. CMS, you know, the intention is to have interim data for them to look at in their population. That'll sit alongside the NHS data and real-world evidence that we've gathered. You know, we've done over half a million commercial tests at this point. And that'll give them a large package to review to make a decision on coverage. Of course, you know, CMS has never reviewed a Multi-Cancer Early Detection test before, so, you know, they haven't stated publicly where the bars are at.
I imagine kinda like with the FDA over, you know, 8 years of working with them on a breakthrough, they'll form an opinion, the more we work together, the more that they understand how the test works and what the benefits are.
Okay. In terms of that, you know, FDA review timelines, the ongoing conversations, is there a timeline you can share with us, sort of like, how that's gonna play out?
Yeah. I mean, I think what the FDA says, has said publicly is if there's no Ad Comm, it's a 180-day review. If there is an Ad Comm, it's 320 days. At this point, we don't know if there's gonna be an Ad Comm. We're preparing for one, just so we're, you know, ready if it happens. You know, that's, you know, the package was submitted at the end of January, so you can, you can all do the math from there.
Okay
If it fits in their stated timelines. We're working with them iteratively right now. You know, when we have something to update, we will.
Okay. Okay. All right. Just to be clear, though, you know, there has been no change in conversation, there has been no change in tone since NHS came out?
No. No.
All right. I mean, maybe let's pivot to sort of like the commercial performance and what you're seeing in the market.
outside of NHS and the FDA process. You know, you talked about Epic, you talked about Quest a little bit.
Can you expand a little bit more on sort of where you're seeing the benefits?
Yeah. Right now our channels, it's really a self-pay test. 70% of it's self-pay, really driven by brick-and-mortar physicians' offices, where we've seen an expansion of physicians ordering the test and also existing physicians order the test more. Things like those tools, like athenahealth, Quest Diagnostics, Epic Systems will really help there. The digital health, I don't know, what revolution, whatever you wanna call it that's happening, where consumers are really driving their own healthcare, through things like Function Health, Everlywell, Hims & Hers, that's a new opportunity, and it's been an opportunity that's shown to be fruitful. It's still early days for some of those partners. We've been with Function Health for a while. We just launched with Hims & Hers.
We'll really see how that expands over time. If you think about it, that's like a captive health seeker who's signed up to care about, you know, how they, how they feel, how they're living. You know, one of the harder parts of finding a patient is addressed. These are people who want to know, want to live longer, want to know what their health is. Generally, they have, you know They'll invest in that. They'll spend their own money on it. The more and more people in the U.S. are combining these digital health platforms with, you know, standard care. You know, like, there's, like, something like, just under 4 billion apps, you know, health, digital health apps have been downloaded in the last year.
Of course, there's some of those are multiple apps for the same person.
It's a good opportunity, and it's really just more proof that there's this large self-pay opportunity, large pre-reimbursement market, as we work toward, you know, the broader access, right? Because GRAIL's been built for population health from day one, you know, making sure that there's a low false positive rate, that it's easy for physicians to implement, and that it can be affordable. You know, the whole plan is to get the price of the test down. The MCED legislation that was passed, you know, that set reimbursement at just about $500, a little bit more than $500, and that's what our current version is built to be able to support margins in the 50%-60% range.
You know, we think it's well positioned, and the investment that we're making now and the traction that we're seeing in this pre-reimbursement space with these partners, with the physicians who are adopting is very fruitful and will help on the broad access side.
You talked a lot about the digital health and some of the newer channels. What about, you know, more traditional channels like Quest?
healthcare provider? Is that gaining traction in the market?
How much of that is about educating the channel themselves, you know, giving sort of the new market opportunity here?
Yeah. You know, as I said, the brick-and-mortar, like, we started in concierge medicine back in 2021 when we launched, whatever it was. Concierge is not a large part of the business. It's, you know, physician practices in areas where there's real champions who physicians really see the benefit of the test. You know, at the end of the day, 1 out of 100 people will have cancer. The physicians who find a cancer, we've found order the test a hell of a lot more than the ones who take a lot longer to find a cancer. You know, commercially, we try to connect these physicians so they can listen to each other and talk to each other. Oh, yeah, your brick-and-mortar physicians' offices continue to grow and expand.
I think we added 1,300 physicians last quarter, if I remember correctly. That's really driven by market awareness. Any of the medical education that we do, any of the social media advertising that we do, and then these physician groups that we put together, you know, that's really how awareness is driven on the physician side. Patients, you know, can go to physicians as well and ask for it, but we find is if the physician doesn't know about the test, they're not likely to prescribe it. You know, I think, you know, there's other market players in there, like Exact's out there now and so on. That's actually You know, driving more awareness. They've got over 1,000 reps, I believe. You know, we've got 150-ish.
What we've found is the more people out there, and we've been waiting for this, helping build the market, add credibility to it, educate people on what an MCED test is, you know, the easier it's gonna be. We're really confident with the position that we're in from a data perspective, and our experience that this is helpful to us, there being more players out there educating.
The physicians that you're adding, I mean, are you seeing any improvement in terms of attach rate, how much they're reordering? Is that sort of compounding over time?
Yeah. I mean, I think our what we call our retest rate, so the people who've come back for another test after getting a first test, is over 30% now, which we're really happy with given that it's a self-pay test. It's not reimbursed. You know, I think for comparison, other screening tests, other stool-based screening tests have about a 30% retest rate after a decade of reimbursement. It just shows this can be a really highly compliant, highly adhered to, you know, technology, 'cause it's blood-based.
You mentioned on other players coming into the market and sort of the expanding MCED landscape.
A lot of that is sort of bringing market awareness. Still very early obviously, are you seeing any change in conversation in terms of competitive landscape or what the alternative tests are?
No. I mean, as I said, you know, we've we're the only company that's got, you know, interventional data, prospective data, not just case control data. Like we can actually tell you what, how this test performs in a population of this room or people who are actually asymptomatic for cancer. Really no one else can do that. We've also submitted our FDA approval. No one else has done that. You know, they're building awareness to the space, which is again, helpful. You know, it's educating more doctors. It's expanding the reach of awareness to physicians. You know, I think that landscape will evolve. You know, we'll see what if we have an FDA approval, what that does to the landscape.
You know, we're excited about the position we're in. You know, that being said, we're always, you know, looking at what we can do to improve the quality of the test, to improve the delivery of the test and so on. You know, we're not just resting on our laurels that we've got like the winning technology, and we're done at this point. We'll continue to monitor and pay attention, but for now it's a bit of a tailwind.
Well, I mean, a lot of the debate we've heard is sort of, having a one-off test versus a cancer care continuum, right?
A lot of the other vendors and a lot of the other players in advanced molecular diagnostics, they'll have therapy selection.
They'll have MRD. They'll have recurrence monitoring.
How do you feel that sets you up in the, in the competitive landscape?
Yeah
in terms of conversations.
with physicians, with channel?
Yeah. You know, some of those are to PCPs, some of those are to oncologists.
Right.
You know, at the end of the day, you know, back in 2024, we focused the company on MSAT when we did our restructuring. You know, we have MRD capabilities. We've got therapy selection capabilities. We have recurrence capabilities. Those are all, you know, investments that we would need to make at the right time, you know, to move things forward to like clinical studies. I've always I mean, I'm the CFO here, I'm not the scientist, you know, I've always said that if you can find cancer in people who don't know they have cancer or you don't know have cancer, you're probably gonna be pretty good about, at finding it in people who you know have cancer. If you get the top of that funnel, you know, the rest of that funnel's gonna be easier to penetrate.
Right now, you know, winning in the MSAT space, creating the MSAT space is where we're investing. I've also always said as the CFO that if we failed at MSAT but won at MRD, we'd be the most expensive MRD company ever funded. There are probably much faster ways to do that than we would have. Yeah, that's, you know Given the position that we're in now, FDA approval in, NHS data read out, we've financed ourselves last year. We've got about $830 million on the balance sheet. You know, now's the time that we can start thinking about what we do with those other product applications, if it's the right time to get back into them.
Okay. You touched on reimbursement a couple times, and obviously the, you know, cash pay nature of the business. How critical is that for you, going forward? You know, do you have various scenarios, mapped out?
Depending on how the reimbursement decisions go, and where, you know, ASPs shake out over the next couple years?
Yeah. Definitely. I mean, you know, from broad access, which is what we've been built for, we're talking about running millions of tests. Like our lab in RTP with the infrastructure that it has today, can already run over 1 million tests, and it can be expanded significantly from there in the same footprint of that building. There's 2 different paths to reimbursement or broad access. There's global, right? There's international, and there's the U.S. Of course, we've, we're working internationally with NHS. You know, we've worked with Samsung. There's ways to get to broad access globally that are actually kind of independent of what's happening in the U.S. We've got the infrastructure to kind of service both. Domestically for reimbursement, you know, we've talked about REACH leading to a CMS.
We've talked about the MSAT legislation that passed, which would allow CMS to start covering the test in 2029 upon a positive National Coverage Determination. There's always, you know, new developments that are happening with legislation or on the Hill. There's a new push for the RAPID legislation or RAPID rules, which would allow essentially FDA and CMS to work faster together, essentially to drive reimbursement for FDA, you know, Breakthrough approved devices faster than the normal timelines. You know, there's all sorts of positive ways that you could get to reimbursement faster. Like we've demonstrated, we're demonstrating a growing self-pay market. You know, a growing pre-reimbursement market in the U.S.
Things like Samsung and some of the things that we're doing, got a distributor in Canada. We've got one in Israel. We'll see what that looks like. You know, we're still talking a million, a couple million tests there pre-reimbursement for now. You know, get into like the 40 million test range with broad access, which is what we're built for. It's mainly we're definitely aware and conscious of running the business pre-reimbursement longer if we need to versus getting to broad access in the proposed timelines.
Okay. I mean, the other side of that coin is COGS and the cost structure, you know, making some progress there. Can you talk about, you know, roadmap there for the next couple of years and how that can help offset reimbursement if it doesn't play out as favorably?
Yeah, definitely. As I said, the version we have now is going to be capable of supporting a lower cost at scale, right? With the lab infrastructure we have now can run more than 1 million tests. If you look at our last 2 or 3 quarters, you can see how many tests we've ran and you can see us growing into that fixed cost leverage and you see margin improvement. That'll just continue to happen. We're nowhere near running 1 million tests a year right now. We can definitely be bringing the price down. We've kind of built the model now and the business now to at like the MCED legislation rates of around $500 plus a test to support a 50%-60% margin, right? That's with the version we have today.
We're always looking at things that we can do, have development efforts to bring the cost down further or to, you know, and or improve the performance of the test. You know, we're going to continue to drive this cost down because it's, we think it should be accessible to everybody. We do think, we do appreciate it's going to be a large line item, budget line item. It might be cost effective. Who knows? It might even be cost neutral someday. It's going to be a large budget item. The more we can bring that down, the better we think for people and for systems who are going to want to adopt it.
Is that operational efficiency? Is that scale? Is that new platforms, new technologies?
Scale and, you know, probably some technology changes.
In terms of sequencing workflow or?
I mean, test format, sequencing workflow, you know, range and so on and so on.
Okay. Any questions from the audience? All right. We'll keep going. You know, you talked about cash balance and the raise and sort of being well positioned there. What are your, you know, investment opportunities or investment priorities in 2026 and 2027? You did a little bit of a commercial expansion so far. Can you just talk about the roadmap there and timing for contribution?
Yeah. The goal is to have those, that specific expansion, those people up and running after ASCO and contributing to growth, you know, by the, you know, Q3, Q4. As far as other investment opportunities, I mean, the whole point of the raise was to give us the flexibility to, you know, intercept, you know, the demand that we believe will come from things like NHS data being, you know, out there and understood, the FDA approval and so on. We may make further investments into, you know, people. We've invested in Epic, right? There's other tools that we'll do to wrap around the, you know, the ordering process, the reporting process that should make things easier as well. Is it alluding to like investing in the next versions of the test and so on.
We may make some decisions to go into things outside of screening. You know, right now we're still focused on MCED. I don't like doing early victory dances. I think investing in things outside of that right now would be a little too early.
Is there an argument of let's, you know, let's chat post ASCO, let's chat post FDA decision, maybe let's chat post CMS, and then that'll determine, you know, are we going left, are we going right here?
Yeah. I mean, I think we'll learn a lot after ASCO. We'll learn a lot after FDA approval. Those two things are not very far away right now. I don't, you know, I don't see myself waiting for CMS to make any of those decisions.
Okay. Okay. Maybe, I mean, maybe a couple of big picture ones. We got about 5 minutes left. You know, you've been talking about population scale screening for a while. You know, you touched on a couple of the barriers there. It's been a long road, certainly. Sort of like, what do you think has been the biggest factor holding you back and the biggest factor holding back broader adoption of population scale MCED? Is it a, is it reimbursement? Is it awareness? Is it, you know, test accuracy and sensitivity? Why is it, you know, it's been a long road if you go back to GRAIL's founding in 2016?
Yeah. I wouldn't put performance as a barrier. It's just an understanding of a new technology. Like the FDA, as I said, we've been working with them for eight years. You know, the FDA didn't have a role, a plan on how to approve MCED tests. CMS doesn't have a plan on how to approve MCED tests. You know, there's just you know, physicians. Physicians, you know, the first thing most people think about is a single cancer test. Well, this is not a single cancer test. You know, most folks don't realize that, you know, when you do your standard of care screening, as I said, that detects about 14% of cancers in the population. That surprises most people when you talk to them.
It's just so new and paradigm changing that you've got to do a lot of education, show a lot of data, show that consistently, right? Be transparent about it and do a lot of work to show that this can work and it works consistently. You know, the barriers haven't really been performance. I mean, as we've demonstrated, I mean, with a false positive rate of less than 0.5%, if you can find four times more cancers than the standard of care, that's a pretty powerful tool. You just have to believe in the tool. You have to believe that that's accurate. You know, ASCO data hopefully shows that. FDA approval shows that. Then we move into the economic discussions with CMS and other large payers on affordability and on the economics of reimbursement.
I mean, to that point, in terms of how paradigm-shifting it is, you know, that kinda speaks to some of the other, some of the other players in the space are starting with a, you know, a single test, and sort of using that to.
into more of an MCED approach. You know, there's a lot of debate on, like, the pros and cons of those 2 methods.
I mean, does that kinda speak to maybe this is not the way to go after? Maybe the, you know, the paradigm shift at FDA and CMS is too much of a hurdle?
I don't believe that. You know, the world has single cancer tests. Developers develop single cancer tests because there's already reimbursement. You have another colorectal cancer test, you know, another, you know, breast cancer test. That's why companies choose those things. You know, when we were founded, we did a bake-off of, you know, multiple technologies, methylation, mutations, fragment, you know, so on and so on, to find multiple cancers, and so we picked that to find MCED. We didn't take a technology that we already had and then shoehorn it into something else. It's simple. Companies go after single cancer screening tests because they're already reimbursed. I don't think that's paradigm-changing at all. That drives more people into compliance of things like colonoscopy.
We're trying to find, you know, as I said, the 86% of cancers that people aren't looking for. That's where you find a paradigm shift.
Okay. Unless there's any, we've got a question.
You talked about preparing your sales force for the upcoming commercialization. Can you talk about the work you're doing with oncologists to kind of prepare for that outcome?
I'll just repeat the question for the webcast. The question was, preparing the sales force, what you need to prepare oncologists.
Yeah, right now the primary orders of this are PCPs. Oncologists, you know, as you guys know, work with somebody once they already have a cancer. We do engage oncologists because they are KOLs and they're thought leaders. Oncologists, you know, that we've engaged are, you know, they're excited about the data at ASCO. Actually I've actually never heard more oncologists say positive things about GRAIL than after the ASCO release went out. Because, you know, oncologist knows that, you know, a reduction in stage 4 cancers of that amount is a very important thing. Physicians don't, and oncologists specifically, you know, would rather treat people with, you know, stage 1, 2, or 3 cancer than stage 4 cancer.
There's a large mortality cliff between stage 3 and stage 4 right now for many cancers due to the advances in cancer therapies.
You know, we have forums, symposiums, we show up at ASCO, AACR, ESMO, and so on. We have a lot of publications out there. The oncology community is an important community, they're not the orderers of the test right now. We're trying to tackle the 500,000 person PCP sale, you know, physicians that are out there, and educate the oncologists as well, which is again, back to the competition. We were doing this by ourselves for multiple years, which is very expensive. There's other people out there helping do it, which is nice. I hope that answers your question. Yeah.
We've got about a minute left, so maybe just, we'll end with our usual closing question of, you know, what do you think is most underappreciated or most misunderstood about GRAIL? A lot to choose from, I'm sure.
I mean, again, the opportunity in front of us, to find more than 14% of cancers by adding one test, with a very low false positive rate, right? You're gonna make the whole cancer detection system extremely more efficient than it is today. The cost of finding a cancer goes way down. It's probably the best shot we have at finding, at bending the cancer mortality curve. Adding single cancer tests, you know, you already have about a 40% false positive rate as a person getting four annual screens. That's just not sustainable. You multiply that by all the cancers that are out there, you're gonna have to start testing an individual for cancers, not an individual for a single cancer.
What cancer does that individual have versus looking for prostate cancer or looking for colon cancer. Our technology does that. All it cares about is finding cancer. It tells you where it's at.
Okay. Well, on that note, we're gonna wrap it there. Thanks everyone for joining. Aaron, thanks for being here.
Yeah. Thank you for having me, Mike.
Looking forward to ASCO.
Yeah, definitely.
Sounds like-
Me too.
must attend.
Yeah. It's gonna be a good time.
Thanks, everyone.
Thank you.