We continue to have one of the most relevant products in terms of content. Back just a couple of weeks ago, we updated our MyRisk flagship product. Now with 63 genes, the most relevant genes in NCCN and ASCO guidelines. It has also been about, you know, the reach that we have with customers. Thousands of customers using our MyRisk product. Quality of the test, the reputation that we have. Customer service overall right now, including not just how you order but the genetic counselors, all the things that we have to really provide that. The other part of the staying power is on the financial side and the operation side. Our ability to process the samples at a very low cost, maintaining one of the industry best, you know, gross margins. All that together, you know, has given us staying power.
And by the way, hereditary cancer continues to be, and I think it's seeing a resurgence, a growth, an opportunity. NCCN guidelines, the unaffected population, $5 billion market. So there's a lot of goodness yet to be had there. We're, we're that's gonna continue being the foundation of the company. The other part of the question is, well, you know, what, what are some of the things that, you know, perhaps have led to, to things that we could do differently? Listen, first and foremost, I say that, we have had three businesses for the, the last several years: mental health, prenatal health, and oncology. And, running businesses, I mean, if you're, if you're a parent, and I'm a parent, you say you love your, your children equally. At least you say, say that even if you don't.
When you're running, when you're running a business, I don't think that's always the best approach, and we have, for all intents and purposes, in terms of focus, in terms of resourcing, in terms of investments, treated all three segments equally. We have updated our strategy now, and the updated strategy clearly says that our opportunity for really accelerating growth in a profitable, sustained way is by focusing in on the cancer care continuum, then for the other segments, growing that in a manageable at or above-market way, so that is gonna be different than the past, which is part of how we perhaps got into a little bit of the challenging position. The other part is, for whatever we do, we've had great intentions, but we have an opportunity to get significantly better on execution excellence.
All the way from how we choose what we're gonna do to how we develop our products and how we launch them on time. So, that focus also will be part of the change of the new Myriad.
Got it. No, perfect. So, you know, 2025 has been a year of overcoming tough reimbursement decision and, you know, maybe the NCCN decision. Some of the things that maybe haven't gone your way last year. Now, going back to February, how is this shaking out relative to, you know, the kinda concerns that you were seeing as you exited last year? I mean.
Yeah. Yeah, good question. So as you've noted, we came into the year with a number of challenges, including the NCCN-related guidelines for prostate cancer, of course, decision by UnitedHealthcare related to pharmacogenomics and that policy decision they made. Listen, since the May earnings call, I'm really pleased with the progress we're making. You know, we've had a couple of really good quarters, Q2 and Q3. We've shown the return to mid-single-digit growth of our GeneSight test. We've shown the continued strength in hereditary cancer, including the unaffected part where we had a little bit of a challenge but going back to growth. We've updated the strategy, which I was just talking about moments ago, which gives clarity to where we're focusing on.
We also have two new products that we've launched: FirstGene and Early Access, which is our combined screening product for prenatal screening, hereditary cancer, the update to MyRisk. We're really setting up to have a year 2026 with a lot of momentum going into it with a number of important catalysts, including the launch of MRD, as we go into next year.
Got it. Well, you know, you talked about growing faster than market and reproductive health, etc. You just kinda mentioned FirstGene. So I wanna talk about, you know, how do you take share from competitors such as Natera and BillionToOne that have, you know, a proprietary single-gene NIPT market or at least grow faster in areas where, you know, some of the competitors aren't winning new market share faster?
Yeah. Yeah, again, I'll start by stating, you know, our intention going forward, updated strategy is to focus on cancer care continuum, and then in prenatal health and mental health, separate dynamics. Mental health, clearly, we are the market leader with the most significant amount of share. We'll talk about that in a moment, but in prenatal health, you know, the companies you mentioned, Natera, BillionToOne, definitely, you know, notable competitors. But there's a market with other players in it too, right? Our way to find success, which again, we've defined at growing at least at market, and we know for the prenatal market, that growth is somewhere in the mid-single-digit range overall for the market. We believe we can do that first based on our portfolio.
At the end of last year, we brought to market an updated NIPS test, Prequel. It's the only one on the market that can be done at eight-week gestational age. That's important because, you know, that's the time when a mother comes in and does a standard battery of tests, you know, compared to nine or 10 weeks, 11 weeks for other competitors. We have now the most comprehensive expanded carrier screening assay, including F8, FXN. And then FirstGene, this is our combined screen that's coming to market.
We believe that, you know, it's in early access now, going to full commercial launch next year, that these things together, along with the experience of how you order our tests, the support we provide all the way from, you know, ordering through to genetic counseling and other support for both patients and providers, that's enough for us to be able to grow at market.
Got it. All right. Well, post-NCCN guideline confusion, what concrete actions are you taking with KOLs and guideline committees to remove the ambiguity? And do we expect an incremental volume uplift if guideline language was clarified?
Yeah, Dave, I believe on this question, you're talking about, you know, the confusion related to guidelines NCCN for prostate cancer, for our.
Yep.
Our Prolaris test. What I can tell you, we are working with a number of KOLs. We have been, we traditionally have, but we stepped that up, as we came into this year. And the purpose of that engagement really is to work with them to speak to other urologists, the customer base on really the merits of our Prolaris test and what Simon Level 1 criteria, if you will, what it really provides or doesn't provide. We do have, along with that, a number of studies that are underway to advance the work that we believe we need to do to be within inclusion on the updated criteria guidelines for NCCN. I'll tell you, you might be aware, a couple of weeks ago, NCCN already updated their guidelines, and Simon Level 1, per se, is no longer there.
Mm-hmm.
But what's there still is certain requirements around, sort of, retrospective tests that have to be done. I feel good about the studies that we're doing that'll get us there.
Okay.
Over the coming 12 months or so, and listen, part of the reason we have an enhanced ability to meet those guidelines is because the access to samples that we have now, as a consequence of the partnership with PATHOMIQ, which is gonna bring to market next year our first molecular and AI test. So I feel like we're making good progress with KOLs and what we need to do related to guidelines for prostate cancer.
Gotcha. Well, moving on to GeneSight, this is a product where I think you are the market leader, for sure. What's your strategy to make this business doable in light of the UnitedHealthcare decision? And secondly, is there a chance that negotiations can go in your favor, with United Healthcare ?
Yeah, I mean, first an update, and it's very recent, as of yesterday, United Healthcare has decided not to change its policy, going in 2026. So we have that clarity now. And along with that, we've never had it within our consideration. We were not counting on any change or reversal of that policy, and it looks like that's at least gonna be the case for 2026. That being said, listen, mental health continues to be one of the most real and difficult things that is facing this nation and around the world. We're very proud that, you know, we're on track to test over 550,000 patients this year, one of the highest NPSs that we have, overall for the testing. And I'll tell you that this business has scale. It's gonna be over $150 million in revenue.
We've shown last quarter, based on the focus and the things we've done, that we can grow it at, you know, mid-single to even low double-digit rates. It has a really strong gross margin. So that together with the fact is, okay, we coming into the year, as you know, we talked about we lost UnitedHealthcare's policy, but we've actually added upwards of 10-plus additional payers, including recently Medi-Cal of California. You put that together with the tailwind from the biomarker laws that are going into effect, we think we have, you know, a viable business here that we can use to serve a lot of patients.
Gotcha. Oh, that's very helpful. You know, I'm actually, I'm realizing right now that we, we have not very many CFO questions. So, Bill, I'm gonna just go ahead and throw a, an extra one to you in terms of, how margins are shaking up in light of, you know, some of these things, including, you know, more coverage for, for GeneSight and some of the other things that have happened this year.
Yeah, no, absolutely. So as Sam mentioned, we've got a very good margin profile for GeneSight. We've got excellent lab processes. And, you know, the medical policy decision relative to UnitedHealthcare is impactful to GeneSight. But when you isolate for that, we've seen progress as it relates to ASP really for the last six quarters as we've gotten traction from the biomarker laws. And it's been across the country. It's not isolated to one area. And we have tailwinds that we expect to continue to be a benefit. And so, you know, not only do we have the benefit from the ASP side, we still also have line of sight to process improvements in the lab. So we are optimistic that we'll continue to see a benefit to the enterprise gross margin line from the GeneSight business.
Perfect. All right. Let's talk about your, your leading product in hereditary cancer. Can you tell the difference between the affected and unaffected market and what is currently going on, in terms of struggles in the unaffected market? Why that's not in the affected market, and how should we expect to turn around, in the unaffected?
Yeah, no, I appreciate the question. And punchline is, we, we've made great progress already. So I think the turnaround is happening as we speak. But listen, the distinction between the two markets, the affected market, of course, is defined by those individuals who have cancer already, and you're using hereditary cancer testing to inform the course of treatment. That's about a $2 billion market. It's highly penetrated, but we continue to have, you know, particularly, based on our reputation, the way we serve, the content, the updated panel, we saw 16% volume growth for affected cancer, hereditary cancer last quarter. Unaffected, now this is the bigger market opportunity, $5 billion, less than a third penetrated. And, you know, this is where the, you know, it's a different market. These are individuals who have familial history, have reason for being tested that could benefit from them. It's a different game.
You have to actually find these individuals, activate the market, and then help the healthcare providers actually identify and bring them through. The challenges, some of the challenges that we had were related to rolling out new programs we were activating coming into the year. And we were having some workflow challenges, including being within the EMR, the questionnaire that's used to identify individuals. So good news is we've updated that. In fact, last quarter, we have what we call our MyGene History, which is the electronic questionnaire that's been embedded in Epic. There are some other workflow issues too that we've been able to handle. Listen, after you know, actually declining, I think in Q1 results related to that, we showed some growth in Q2. And last quarter, we grew 11% in volume. So we're already returning to growth, and we're really excited.
Listen, when you look forward into the market, we think based on things that we're doing, we call the Breast Cancer Risk Assessment Program, which really enables these healthcare providers to find a way to identify these individuals, pull them through in a way that there's a virtuous cycle for them to pull it through, through how they can bill. We think that together with how we're, you know, restructuring our sales teams as we go into next year to add more feet in the street, add more focus to hereditary cancer testing in the unaffected, that these two categories of hereditary cancer, affected and unaffected, are gonna continue being a very important growth driver, enabling us to grow low single-digit, double-digit overall for the company.
Got it. I'm gonna move a question forward to make sure we get,
Yeah.
The MRD question in your terms of strategy. In terms of bundling it or selling it in the channels that you're already in, so can you talk about your right to win and kinda what the pitch is to oncologists that are using your product in, say, hereditary cancer in an affected population?
Yeah. Great question. Dave, well, I'll start with, you know, the market overall for MRD. We can dispute what it is, but it's huge. We know that, and we also believe that, you know, history has shown that a market opportunity like that will be served by multiple companies. The reason that we believe that we have a right to play, right to be considered, includes the fact that we have a real strong footprint, presence, reputation in breast cancer, ovarian cancer, prostate cancer, a number of other cancers, particularly in the community. That's where our strength is. We have an assay, Precise MRD, which we'll be bringing to market, the first half of next year, which really is differentiated in terms of performance.
Because of the whole-genome tumor-informed approach and the specific technology that we use, it's able to detect down to less than five parts per million. Now, this matters for these low-shedding cancers, such as, and that coincide very well with the cancers I talked about where we have leadership: breast, ovarian, and so forth. That, together with the fact as we really spent time, what's important to these healthcare providers, it's being able to use one or a very small number of lab partners that give them the most relevant test content information to determine what to do with a patient.
So the fact that we are already a leader, not only in hereditary cancer with MyRisk, but also HRD with MyChoice, now together with a differentiated assay, the reputation, the reach that we have already being embedded, many of their EMRs, that's what we believe will give us the opportunity to play. And then over time, it's gonna be how we expand the portfolio. For us, as we're starting, but, you know, as we come into January, I'll be sharing a, you know, two- to three-year roadmap of the other cancers and the indications we'll bring to market. And that comprehensiveness together, and you're absolutely right. We see the bundling opportunity. We're already seeing that, by the way, in our prostate cancer and other franchises because of the NCCN guidelines being updated.
When even a urologist is ordering prostate cancer Prolaris test, we see an increasing number of bundling with our MyRisk test there. So we.
Mm-hmm.
Expect it to be the same in MRD and a virtuous goodness, if you will, created by this product.
Gotcha. Well, I don't wanna get in front of any kind of announcement here, but can you talk about some of your significant bets in the R&D pipeline and some of the novel, or some of the anticipated timelines of the novel test to reach commercialization?
Yeah. I'd start first by saying, again, consistent with our updated strategy, the most important area of focus for us, including in R&D, is related to the cancer care continuum. So when you look at some of the most important things we're working on, MRD first and foremost, we were just talking about that. By the way, we're excited that next week at San Antonio Breast Cancer Symposium, we have two late-breaking abstracts, one from the MONSTAR-SCREEN-3 study with our collaborators in Japan, one with our collaborator here at MSK, MD01, that will really be about breast cancer. And I think that will, you know, speak to some of the R&D work that we're doing. We have more than 20 different studies in MRD, and these will be across a number of indication cancers.
That will be, for the next two to three years, the biggest thrust that we have. Now, along with that, an important change of the new Myriad, Dave, is about everything doesn't have to be done at Myriad. We think that partnerships play an important role to allow us to serve the market quicker than we could in high-growth, important attractive markets. Case in point, some of our co-development R&D focus is with our partner PATHOMIQ right now on the prostate cancer area. We're starting with the first test, but we have a second test there too. You know, beyond that, we have some other areas, but those are the most important R&D focus areas to support our pipeline that we think we're gonna have a steady stream from in the next couple of years.
Got it. Well, Sam, I'm gonna ask you to put on your Dale Muzzey hat here and maybe if you could talk about actually the most recent San Antonio Breast. I believe you did share some MRD data, and we have some, you know, some positive elements in kind of some of the low-shedding, tough-to-find cancers. So is there anything you maybe could that investors could take away? And again, I know Dale's not here, and it kinda puts you on the spot there, so.
No, I appreciate the question. Listen, what I can tell you is, as it relates to what will be announced, clearly it's under embargo. It's still a late-breaking abstract. It will be in breast cancer, in neoadjuvant, and further provide credence to how the level of sensitivity that we have and the detection capability based on less than five parts per million, but a high level of reproducibility really makes a difference in breast cancer.
Mm-hmm.
You know, that's gonna be the key takeaway. And then I think the conclusions that can be drawn, particularly when we put that together with the data we shared at ASCO, AACR, is the extensibility of that methodology and that technical performance, as it applies to a number of other cancers. And this, you know, together with data that was in the Lancet Oncology, about a couple of months ago, also shows the clinical value and utility of being able to detect, you know, months before, several months before, traditional imaging. So that, that's.
Oh, yeah.
Yeah.
All right. Well, thank you for doing that one. So switching back to prostate, the PATHOMIQ deal was framed as accelerating level one evidence and adding AI for post-operative prostate care. How are you thinking about that evidence generation and, you know, what can you do with this from, you know, the standpoint of NCCN, commercial go-to strategy, etc.?
Yeah. Well, I'll start again by saying that we have a number of studies that are underway that we feel are really gonna help us not only set up the product for success in the market in terms of clinical utility, the evidence that we need to really help adoption with actual providers, but I think these studies will also help us, you know, advance our position as it relates to guidelines with NCCN. Importantly, I've already noted previously, category 1, that already seems to be something that has now passed. I mean, as of two weeks ago.
Mm-hmm.
But we still wanna get ahead of what the new guidelines look like. And I think we're gonna be in a good place over the next 18 months or so. Now, we're not waiting for that. In advance of that, our first test for Prolaris, which is our prostate cancer test, combining molecular and AI, is coming to market first half of next year. And that, we believe, is gonna actually start accelerating growth. We've been holding our own, but in a market that's growing, holding your own, that's not good enough.
Mm-hmm.
We think that's gonna bring us back to growth. By the way, even other tactical things like adding more sales reps, we think that's gonna give us more coverage. So we expect 2026 to be a year of growth for our prostate cancer franchise.
Yeah. Sounds great. Can you talk about some of the other stuff in your oncology portfolio that would work well with, you know, adding MRD kinda products, therapy selection, or anything else there?
Yeah. We've talked about, you know, as it relates to somatic tests that we have. We were clearly just talking about prostate cancer. So I'll talk about MyChoice, which is our HRD test, and our Precise Tumor, which is our CGP tumor test. Listen, MyChoice, we are also a pioneer, a leader for ovarian cancer. This is an FDA-approved test, particularly for determining individuals that are appropriate for PARP inhibitors. It's been a little flat over the last couple of years, but we're expecting growth in 2026 based on pharma now starting to use this HRD test.
Mm-hmm.
To stratify patient populations for other ADC and other tests that they're doing. We're also gonna be expanding beyond ovarian cancer into other cancers like breast and prostate, which we think will also help drive growth the outer years. Precise Tumor, which is our therapy selection CGP assay, this is, you might recall, we acquired some assets from Intermountain Precision Genomics about a year and a half ago, and once we brought it into our portfolio, we saw some initial growth, and it's stagnating over the last couple of quarters. But what's gonna be different and why we think we're gonna drive growth, going forward is, at least two things. One, we've recently done the integrations, putting this in the Flatiron, as well as a number of the other EMRs.
We're also adding now, as part of the new Myriad going forward with the cancer care continuum, a new set, a significant number of sales team members that really come with a background of tumor and precision medicine. So.
Yep.
This together, I think, is gonna help drive these core products together. As what you said, Dave, listen, it's about having the portfolio of other products. MRD is gonna help pull this through.
Mm-hmm.
As we bring that to market.
Got it. Ben, I'm gonna create a question for you. I'm just 'cause well, you know, you have had industry-leading 70+% gross margins. I mean, I think that does make the business quite unique. Though, you are gonna be launching new products, particularly MRD. You know, you hope to have, you know, generate pretty good growth there. At least initially, that does tend to be sequencing intensive. So, I mean, can you talk about how MRD could impact gross margins over, say, the next two to three years?
Yeah. So Sam and I talk a lot about that, and well, part of how we're gonna approach it is just be thoughtful as it relates to, to the volume, right? So obviously, it's important to get the, the volume coming through from a clinical standpoint. We wanna make sure that, that people are able to, to use the test. But we're very cognizant of the fact that it is impactful from a margin standpoint. And as, as Sam has, has talked about frequently, the third pillar of our strategy is to, to grow profitably in a sustained way. And so we'll, we'll be mindful of the, the amount of volume that we have from an MRD standpoint in 2026, and then also as, you know, we move forward in 2027 and 2028, as, as we expect it, that we'll have, reimbursement in a different way in 2027 and 2028.
So, we recognize there will be an impact into margins, you know, going forward, and it will likely be, you know, most impactful in 2026 and 2027, but we'll just meter the volume.
Listen, it's about scale in MRD, right? As we really get into the tens of thousands of samples as quickly as we can, we think that's gonna help bring down the costs. And, you know, the fundamental thesis of Myriad remains now to be able to grow high single-digit, low double-digit. We believe with the portfolio we have, the partnerships we're bringing in, Dave, that we have the ability to do that in a sustained, profitable way. And that's gonna be part of the differentiation of this company.
Perfect. All right. Thank you very much for.