Great. Welcome back from lunch, everyone. My name is Sebastian Sandler from the Life Sciences Tools and Diagnostics team at JP Morgan. I'm pleased to be joined by the Caris Life Sciences team. As usual, there will be 20 or so minutes of presentation followed by Q&A. And so with that, I'll kick it off to the team to get things going.
Great. Sebastian, thank you. I'm Brian Brille. I'm Vice Chairman of Caris Life Sciences. I'm joined by David Spetzler, who is our President, as well as Luke Power, our Chief Financial Officer, so Spetzler and I were just commenting. We've presented here for many years, but this is our first year as a publicly traded company, so thank you all very much who have supported us. We went public, as you know, in June of last year, and I thought it was sort of appropriate to start by reflecting on sort of where we are. We thought that for us, 2025 was a very important year, a year of transformation in many respects for us, so with the IPO and with the new ASP, our financials are in a completely different situation, so we've ended the year with $800 million plus of cash.
That's up about 5%, actually, through the quarter. We also are very strong from a P&L perspective. So the ASP pricing that has gone through our P&L, I think it's important to note that that has been driven by technology and by a technology investment and decision, a strategic decision that we made many years ago to go to whole exome, whole transcriptome. So the pricing, both with respect to CMS as well as the private sector, has followed that and has left us now with a P&L that's generating very strong cash flows, very strong profitability. And we think just given the opportunities that are inherent in this market and molecular information and profiling specifically, that gives us a huge edge. And we are going to use that edge. We're going to use that edge with respect to internal product development, further development of our channel, et cetera.
The therapy selection business, our core business historically, has been a real growth engine for us. The clinical case volumes have been consistent. The pricing has been moving up. That core engine of growth gives us a lot of stability, confidence, and position then to really focus on our product pipeline. Spetzler is going to talk about that. We're very excited about developments with respect to MCED and other product capabilities. From the very beginning, we have been focused on more information is more power. That led us to the decision to go to whole exome, whole transcriptome. That's every patient has that. That's a core capability and a huge edge for us. We talk about technology a lot. The market talks about technology a lot, but that doesn't get delivered without a platform.
So we also have what we think is a huge edge for us with respect to the scale of our platform, the distribution channel, et cetera. We completed about 200,000, just under 200,000 individual genomic profiles, individual patients last year, 199,300, 22% case volume for the year, all of which was with 23,000 genes, a DNA and RNA. That put us past an important milestone, we think, of a million individual genomic profiles in our data set. And that was delivered through a distribution channel that's reaching now over 6,000 ordinary oncologists. So this data set, we think, is very special. The 678,000 transcriptome data set is the largest in the world. And across the million profiles, about 75% of that is matched with clinical outcomes information.
So we think this gives us a huge edge, both with respect to internal product development as well as being a very attractive partner to academic medical centers as well as biopharma partners. The market trends, we think, are fabulous, as good, frankly, as they've ever been and getting better. So the TAM, regardless of how you look at it or how you measure it, just with respect to therapy selection, the TAM is large. It's growing. It remains underpenetrated. Only about a third of the patients are getting comprehensive genomic profiling defined by a 300-500 gene panel, let alone whole exome, whole transcriptome or beyond that. So there's much more work to do in terms of reaching all of the patients and supporting all of the physicians in the United States and more broadly to provide the best technology possible. But the trends are very good.
Comprehensive genomic profile is clearly recognized as standard of care. The market's moving in that direction. So a lot of what we're doing is continuing to build our platform to reach as many individual oncologists as well as setting up precision oncology programs for the cancer centers. There's a whole series of trends that are driving the senior leadership of cancer centers to have a need to set up real precision oncology programs, ranging from things like genomic metrics being incorporated as part of quality metrics for hospitals and cancer hospitals to the need for branding, attracting physicians, attracting patients, et cetera. So while we're providing a technology and a test, we're much better understood as providing a strategic relationship and a service to the cancer center, supporting them across the board in many different ways. They generate through their clinical activity. They generate clinical outcomes.
They're also very interested in combining that with the best genomic information possible. So the conversations we have with our partners are along the lines of, well, you're generating all of this data. You have an interest in this data for a whole variety of reasons, whether it's trials or research or whatever. Why not have the best genomic information to combine with that clinical data as possible? We get questions about internal labs from time to time. Internal labs have been out there for a while, and that's about roughly maybe 10% of the market, but the reality is that they're under pressure. They don't have the competitive edges. They don't have the scale, and increasingly, these things are even more important.
The investment necessary and the scale necessary to really deliver the best technology is such that these internal labs are looking for partners, and they're looking for partners like Caris. So that trend has been in place in terms of outsourcing for quite a while, and we think will only grow more pronounced going forward. So we've set up our channel and our go-to-market to match these trends. We have been focused on the patient-first philosophy, we call it, from the very beginning. We're a tech company. We're proud of that. But we're also a healthcare company. And our clients are obviously physicians and cancer centers. And they appreciate that. And they want the best technology, but they also want a company and a partner that is focused on the patient and understands the healthcare services business. Our commercial platform, we think, is very talented.
We have 250 people in the field, about 50 MSLs, PhDs that are field-based, supporting our clients. They're wearing two hats in many respects. They're working side by side with the treating oncologists to help find the best treatment protocol, find the best trial matching, but also, in many cases, doing research with those cancer centers as well. So it's a really interesting and powerful go-to-market fit for us. Covering these institutions from both the individual oncologists, bottoms-up perspective, as well as top-down strategic perspective, we think, is critically important. We think we do that very well. It's been our strategy for some time. We have a dedicated team that covers the cancer center directors, deputies, et cetera, and that has been the team that's built the Precision Oncology Alliance, which is now up to 99 cancer centers across the United States and globally.
And you can see here, I mean, these logos, it's really, I mean, it wasn't that long ago, Spetzler, this page was not that populated, but it's grown dramatically. And we're very proud of it. These are all great institutions that are very proud to do research with us, to use us as their precision oncology partner in many different ways. We added in the last quarter two sites, a Swedish in Seattle, part of the Providence Network. They also have the Paul Allen Cancer Research Center, which is really interesting. So we're very excited about what we're able to do with these folks going forward. We also added Arkansas. And together, all of these 99 sites represent and incorporate about 4,000 medical oncologists, or about 40% of the overall market. So this growth has been very consistent, actually, over the past number of years. We're at 99 now.
Full penetration is probably in the 120-ish range. We're not managing anymore to a particular number. But these top-of-the-house strategic relationships give us the opportunity then, going forward, we think, to have more in-depth conversations to really penetrate the relationship broadly across all of the different departments and up and down the org chart of these cancer centers. One of the things we do is we publish with them. They love this. We love it. It's just a great synergy. And we're now at over 1,200 publications that we've done jointly with our partners. The channel itself is tailored for the different market segments. I think it's important to note that, on the one hand, the market is described as 80% community, but it doesn't operationally fall into that category. So many of the community docs are in an institutional format.
So the academic centers all have networks for the most part. And that's about a third of the market. The corporate PPMs or physician practice management companies like US Oncology and others, those are community sites, but they're organized in a corporate format. So two-thirds of the market is really institutional and involves institutional senior-level decisions. And our go-to-market is structured that way. We have a very talented team of senior people who cover them from the perspective of the cancer center as well as the salesforce that covers the individual physicians. You can see on the lower right here, our salesforce has been relatively flat over the past few years while we've doubled volumes. But with the financial position that we're currently in, we feel like we're in really a unique position to grow, add capabilities here. And I think Luke will talk about this.
We're going to definitely be investing in our salesforce to broaden the reach, get to more cancer centers, more individual physicians, and to be able to do more with our client base, so I mentioned we profiled just under 200,000. In 2025, we did 52,700 for the fourth quarter. That's 20% year-over-year growth, 22% growth for the year, and we're very bullish right now. We think we're in a situation where we will see accelerating growth. We think the market's there in terms of the TAM, the underpenetration of it, and also, importantly, our positioning in our edges to go after those opportunities in the market, and they range from technology leadership, which Spetzler in a minute will go into depth on, our product pipeline. We're super excited about that. Our channel is very differentiated, strong relationships growing all the time.
As I mentioned, I think we're going to invest in this. Our financial profile, we did $281 million of revenues in the fourth quarter, reflecting 116% year-over-year growth. Our cash position is very strong at $800 million and going up. With all of that, I'll turn it over to Dr. Spetzler to go through our products and pipeline. Thanks, Brian. Yeah, so I get the fun part to talk about all the new and exciting stuff that we're doing. An update on our multi-cancer early detection activities. We had talked about AchieveOne, which is our first validation study of our MSED. The enrollment is complete. We'll be reading that out towards the end of this quarter. We're processing the samples as we speak and have finished about 30% of them, just over that. The initial results are incredibly promising.
This is using a whole genome approach. It is the deepest sequencing of a whole genome that we've ever heard about. So the amount of information that we're getting from this approach is really amazing and quite fantastic. So we're super, super excited about multi-cancer early detection, specifically making sure that we don't leave patient populations behind. So one of the core attributes of Caris is we want to build the best tests possible. And we don't necessarily care how much they cost in the beginning. We want to maximize the biological information that we're generating for patients. And this approach is doing that in spades. And so we're very excited about that approach. We've been concurrently enrolling patients in AchieveTwo. So that'll be our second major study. And we added just under 3,000 patients in the last quarter to that study.
And so we've got another 6,500 or so patients to enroll in that one. And so it'll read out towards the end of this year. And we're very, very excited about that. In addition to advancing the science, as we announced this morning, we have our first commercial partner to enable access to our MCED. So we've partnered with Everlywell, who has a pretty substantial reach, serviced over 60 million customers to date. And so this is a mechanism by which people will be able to get access to the amazing technology that we've developed to allow them to find out if they have a cancer that they need to deal with. And so we're very excited about that. And we'll be commercially launching this as soon as we finish AchieveOne readout, which we're very, very excited about, as I said. Price point is $3,500.
So as I said, it's not necessarily a cheap test. But that's because we're not aiming towards minimizing the cost. We're aiming to maximize the performance. We are at a point in the development of MSEDs where we should be focused on the science and building the best possible test. And we'll bring the cost down later on. Another exciting aspect and new product is Caris ChromaSeq. So this is a whole genome and whole transcriptome technology. So this is taking the same fundamental technology that we used in our FDA product and now expanding it beyond the exome to the entire genome for hematological malignancies. And so we've completed the validation of this product. And it is currently under review by MolDX. And we will be launching it imminently as soon as we have finished that technical assessment with MolDX.
But similar to our MCED, this is a deeper whole genome than we've ever seen anybody else do. So again, trying to maximize the amount of information per patient. And it's really extraordinary. And that's kind of doing the same thing that we did with whole exome, whole transcriptome, looking into the future. We know that whole genome is going to be there. And so we want to start to build that database now early on so that we can take advantage of that information in terms of new product development and new insights as time goes on. Because we all know that sequencing capacity will continue to improve. Prices will come down. It's really taking advantage of that patient sample. And that's the most precious thing in this entire workflow. And getting that information now gives us a significant edge and advantage.
Another one that we announced at San Antonio Breast Cancer is MI Clarity, Caris MI Clarity, so this is an assay that is the first of its kind in a very unique way in terms of incorporating true multimodal data, so we're using AI applied to both the H&E image as well as to the DNA and RNA results coming out of MI CancerSeq. With all of that information, we're able to ascertain the likelihood of a woman having a recurrence event after curative intent surgery, so there are already tests on the market to try to service this. But it's fairly old technology, and so we were able to acquire the samples that were used to validate those other tests and use those exact same samples in the validation of our test and see substantially improved performance.
And so there are still too many women that can have a recurrence that should be going on adjuvant chemotherapy post-surgery that are not going on it. Just as likely, and even maybe more important, are women that are going on adjuvant chemotherapy that don't need it. And so with this one test, we're able to identify those patients that have a high likelihood of both short-term early recurrence and long-term distant recurrence. And so in one test, you know what to do initially after surgery in terms of adjuvant chemotherapy. But you also know what to do after five years in terms of extended endocrine therapy. And so we're very excited about this one because it truly starts to bring AI to the forefront, utilizing that both in the image and the genomic data simultaneously.
With respect to minimal residual disease and MRD, we've got the tissue naive approach that we talked about before going through that reimbursement pathway. But we're also then launching a whole genome-based tissue-informed MRD as well. And so this is utilizing that genome platform that we've created both for MSED and for hematological malignancies, using that to find trackers. And we're maximizing the number of trackers to have a super ultra-sensitive assay. And we're looking forward to that as well. Our plan there is to go pan tumor and to make it available to also stage one patients. So there's an opportunity to understand the progression of disease. And that understanding shouldn't start at stage two. It should start at stage one and ideally even earlier than that. And so again, maximizing the amount of information is part of our fundamental philosophy.
We'll be doing that with our MRD approach as well. Then just a couple of updates on the BD side of things. We announced the closure of a Caris Discovery project with Genentech with an upfront milestone payment of $20 million and a total contract value of over $1 billion. We're very excited with this. Genentech makes amazing drugs. Leveraging the data that we have and the technical capabilities that we have to find new targets and new opportunities to patients is how we're going to start to bend the bar even more in terms of helping patients survive. This is another one in a long series of strategic partnerships to identify new drug targets. It's the biggest one to date. We're very excited about this and helping patients live longer.
With that, I'll turn it over to Luke to cover our financials.
Thanks, David. So a lot of these numbers that I'll go through were obviously in our earnings release this morning. One of the key things for us going into 2025 was obviously proving out the profitability thesis, and we obviously succeeded in that substantially, and I think one of the key things, obviously from a growth standpoint, getting to $281 million, even though it includes true-ups, a lot of those true-ups were related to 2025, which is what we called out in our earnings release, so again, the power of the ASP, but also the power of the volume. One of the key things for us is obviously we're very upfront about what we disclose from a volume standpoint from tissue and blood, but currently, it is only therapy selection.
I think one of the key things for us as we progress into 2026 is obviously getting through the pipe that Dr. Spetzler talked about today. And the key focus for us is obviously the first half of the year with early detection. David Halbert has been pushing this since he formed Caris. It's a transformational technology. And that's why we want to get it out there as soon as possible. And that's why we're pursuing the self-pay path. It's the quickest path for us. And to David's point, I'm in a unique position as a CFO. Our CEO will never talk to me about costs. He always wants the best technology. It's why we went to whole exome and whole transcriptome before we had reimbursement. It was the best thing to do for the patient. And we're going to continue along that path with the pipe.
Even with whole genome, reimbursement is going to take a little longer to catch up. But we believe it will. And you'll see this in others in our space too. You're going to see the expansion trying to catch up. We went to whole exome and whole transcriptome back in 2018, 2019 because it was the right thing to do. We're doing that now with whole genome for early detection. And I think that's going to be our next kind of accelerator or catalyst as we go forward and we find more and more data that no one's seen before. So from a performance, financial performance, obviously the ASP has been fantastic. We definitely think there's room for growth there. There are insurance payers out there that their medical policies, we would like for them to be updated. You should not be denying coverage for molecular profiling at this stage.
I think as we grow, we'll get that message across. And not just us, obviously everyone across the industry is going to keep pushing insurance to obviously get their policies updated. So from an overall performance standpoint, from a financial performance, having $800 million in cash, we're going to use that going into 2026. One of the key things that we're going to focus on, obviously along with the pipeline, is we're going to be expanding our commercial org. One of the things that we've done really good over the last couple of years is being kind of capital efficient. And we're going to maintain that. But we definitely think there's room for growth across our commercial org in that kind of 20%-25% increase in headcount.
So that's kind of the key focus going into the first six months of the year along with getting early detection launched. From a revenue performance standpoint, obviously one of the key things we discussed during our roadshow, we've always been clinically focused. That's what the company was set up to do. We have the mom rule, treat every patient as your mom. And that's always been our kind of key revenue generator. And that continued into 2025. Obviously, from a pharma standpoint, that's been kind of second for us. But what we're going to do in 2026, along with our commercial for the molecular profiling business unit, we're going to expand our pharma team quite drastically. Because again, we've proven the profitability thesis. Now we're going to drive the growth for 2026 and beyond.
Even though pharma was down year over year, one of the key things, and David touched on Genentech, we signed that deal late in Q4. So there was no revenue in Q4 related to that. So that goes into our pipe for 2026. We also have a couple of more deals that we're very close to finalizing that will continue to kind of drive that pharma growth up. And I feel very confident about that going into 2026. From a molecular profiling services, obviously the performance speaks for itself. From a therapy selection volume standpoint, the 22%, obviously 20% in Q4 was a step up from the 18% we had in Q3. So I was happy with that. I think what we're going to do with our sales org going forward, we can definitely drive that more along with medical policies and along with our obviously education out there.
I definitely think there's room for improvement there. Again, you'll never hear me guide to it because I'm that type of CFO. But I definitely think we're in a great place to start 2026. And then the last thing I'll touch on is ASP. Obviously, there's a lot of questions out there about our true-ups. So the bulk of our true-ups were actually from cases this year. When we actually launch a new product, we like to give it about six months before we actually start stepping up our ASP because we want to see the history from the payers. So that's what occurred in 2025. We had about $135 million of true-ups, but $102 million were related to 2025. So the true revenue number that you're looking at and what we actually recorded for Q4, again, these are all preliminary numbers. They're not audited.
But our Q4 tissue base ASP was $3,800, which again was a good step up from $3,500 in Q3. And then also for blood, we stepped up to $2,500, which had the benefit of obviously what we're doing with our tissue business, getting more and more contracts signed for blood. So we feel very good about our profitability and where we're at today. Now, that being said, I will never guide to a profitability metric. We're not at that stage of our journey. I definitely think as we push towards growth, that's going to be our number one focus and will be for the next kind of two to three years at least. And going back to what David Halbert has always told me, we have a technology that we're going to focus on, and that's going to be the driver of the company going forward.
It's going to be transformational. And that's why David Spetzler, Brian and I are so excited for 2026, even though 2025 was obviously a fantastic year for us. So I'll stop there and open it up to questions.
Great. Great. Thanks for that overview, guys. Maybe just jumping right into it. So you pre-announced 4Q top line results above the street, driven in part by case volume and then largely from ASP with some of the true-ups you called out. So maybe digging into case volume, particularly for Caris Assure, can you just unpack for us how that launch has trended relative to your initial expectations? Where are you seeing the best traction? Where are you seeing opportunities for improved uptake?
I think you'll see opportunities across the board, to be honest. Obviously, we've been very upfront that we're working on our next version that's going to go to New York State, and it's going to go to the FDA, and that's something that hopefully we'll obviously be working on to complete in 2026, so that will be the next catalyst there. I think from an overall trajectory standpoint, obviously based on what we discussed during kind of the IPO, we're probably like a quarter or two ahead of where we were kind of expecting, so we are seeing uptick there. We got to like 8,500 cases. We were kind of expecting the 8,000 cases for Q4, so I definitely think as we go forward, we should be growing there more substantially from a growth rate than our tissue business, which is obviously our legacy business.
And I definitely think there's huge opportunity there because obviously blood's a lot easier to get than tissue. And also you have the opportunity to go and do multiple tests with blood. And that's why we're excited, not just for obviously our therapy selection business, but also like MRD and then early detection. You're going to have multiple tests per patient.
Yeah. Great. You brought up the New York State approval. Can you walk through the latest timing on that? And then assuming that maybe falls in 2026, how that could translate to volume growth? I think New York is one of your largest tissue states, so we would expect some impact from that.
Yeah. We try to avoid guidance on timing when it's outside of our control. So we just don't know how long New York State Department of Health will take in the review of our submission. But the submission is within our control, and we'll be getting that in as soon as possible.
Yeah. And then, to answer the volume question, like you're right, New York State is one of our biggest markets from a tissue standpoint. I definitely see we'll see uptick there. It's not going to be a hockey stick. It's not flipping a switch. I think there's going to be work. And obviously our commercial team will have to do the work like they've been doing in all the other states. So I definitely think there'll be upside there. But again, it's not going to just be an immediate flip.
Maybe moving to the tissue side of things. So you called out some of the sales rep dynamics and the headcount coming down since 2024. With less field reps, you can imagine there might be less interaction. So how should we think about the impact of this headcount reduction to volumes? And then looking ahead, it sounds like that's an area of investment that you're focusing on. So where would you like to grow headcount to? And then just generally, what is your framework for balancing volume growth and profitability moving forward?
Yeah. So it's kind of funny, and David has always warned me about this, about becoming a public company CFO. When we were private, obviously you're burning money. We were being very capital efficient. And that was kind of a natural attrition getting down to the 250. We didn't do any reduction in force. It was more just a natural attrition because every investor was telling us like, "Stop burning." And now we've turned that corner and it's, "Okay, don't worry about burning." So what we're focused on going forward, obviously from a sales standpoint, with the profitability and with obviously the ASP turn, they're going to generate a lot more return on the investment than what we've experienced in the past. And that's one of the reasons why we're focused on that 20%-25% increase in headcount from a commercial sales org.
We definitely think it'll have a quicker return on our investment. So that's kind of where we're looking at from that standpoint. And I think as we go forward, again, we're always going to be capital efficient. It's just our nature. And we're always going to look for being the most efficient from operating the business. Obviously, David has demonstrated that historically based on his previous public company. So I think as we progress into 2026, it's more just runway for us. We're in a great position with the $800 million of cash on hand. We're not going to burn from my management standpoint. If I'm not burning, I'm okay. So I'm not going to try and maintain getting to an EBITDA of 20% margin or 30%. I just want to continue to push on the technology that David Spetzler is very excited about and David Halbert's very excited about.
That's our number one investment. Our number two investment then is building out the commercial platform because we have a lot of great relationships that Brian touched on with our POA. I definitely think we can expand the reach so more patients actually get access to our testing.
Great. Maybe let's move to the pipeline, which has been an investor focus. So during the three Q call, you introduced the Achieve trials and provided some helpful details there during your presentation. Can you just talk more about how long these trials were in the works, more about where Caris gathered the samples, and then any partners or investigators that are involved and worth calling out?
They've been in the works for multiple years. So we have, I don't know, 30 odd sites that we're collecting samples from and enrolling patients in. So we've never been the type of company that is flashy in terms of saying all the stuff. We just keep our heads down and do the work. And now that work is almost done. And so that's why we're talking about it.
Great. Maybe moving to MZ. So you're targeting a launch in the first half of this year, targeting cash pay patients. Can you talk more about how you envision this market taking shape for Caris and the strategy around convincing providers and patients that whole genome is the best test method? And then maybe, Luke, can you touch on any color on the target gross margin for this test at the target price of $3,500?
Yeah. So the technology really needs to be measured by your stage one and stage two sensitivity at appropriate specificity. And so the key here is that if you start to look at what are the most common stage one cancers that are out there, it's breast cancer, it's prostate cancer, it's lung cancer, it's colon cancer. And so those are tests where there are already screens, but the screens are not that effective. I mean, the fundamental sensitivity specificity of mammography is about 60% and 80%. We use that as our standard of care, but that's a really low bar. And so as you're developing a multi-cancer early detection, the key word there is early. So it's got to be focused on that stage one and stage two performance. And we can't miss the most common cancers.
We don't want to miss 97% of breast cancer, stage one breast cancer, or 98% of stage one prostate cancer. We want to catch as many of those as possible. And so the technology at the end of the day has to match the biology. And those two cancers are unique because they're hormonally driven cancers. And so if you're looking for methylation changes, there's a reason why you're not finding them in those cancers because those cancers aren't driven by methylation changes. And so the whole point of the technology should be to identify and go after the biology. So the technology is just the tool and the biology is the source of the problem. And what we need to do is maximize that stage one performance because that's when we can truly cure cancer. That's when we can have a really significant impact.
And when you achieve that, then you're talking about the entire world is your TAM. And that's why it's so exciting is because this isn't just a disease that is specific to one patient population. This is everybody on the planet. And at the end of the day, when you start to think about the nature of disease, it's cells going wrong. And if the cell is going wrong, there's something in the molecular system that's gone wrong. And so by doing this approach, by measuring everything we possibly can, we're not only going to have great insight into cancer, we're going to have great insight into everything else as well.
And so this is the platform by which we start to change all medicine because at the end of the day, if you can catch a disease early, then you can do something about it before it's symptomatic, before it's always caused all the other systems within our bodies to fail. And that's why we're so excited about this approach. I mean, a whole genome wasn't possible even a few years ago at the scale that needs to be done, at the depth that it needs to be done to start to deconvolute the biology. But now it is. And so we're at the beginning of an incredibly exciting journey, not just in oncology, but in every other chronic disease as well.
So that's why we don't care about the price or the ASP because this is the beginning of a technological revolution, and we don't want to slow it down by underinvesting. We're just going to go for it. And that's what we've always done, and that's what we're going to continue to do.
Yeah. And to answer the question from a gross margin standpoint, Spetzler obviously touched on it. We're doing this at an incredible depth for a whole genome. So it's a very expensive test. So the $3,500 price, that's not a 60%, 70% gross margin product, but it's not a negative gross margin product. And because of the position we're in, and this is one of the unique things about Caris, is we're more focused on the technology now that we've proven kind of the profitability side of the business. So launching something and getting something out to the masses that's a neutral gross margin, I'm okay with that because we want to get the technology out there as soon as possible. Now, again, in three years' time, four years' time, it's similar to what we have experienced with our tissue assay.
When we launched whole exome and whole transcriptome, there wasn't the NovaSeq, there wasn't the NextSeq, and that caught up. It's the same thing that's going to happen here. We just want to focus on the technology first, and then the cost and everything will come years later when sequencing improves.
Great. Maybe one on MRD, on the tissue-free side. So you submitted the technical assessment to MolDX. Can you walk us through how any conversations there have been progressing? When could we potentially see some top-line impact from that if everything goes as planned? And then do you need to wait on any data from AchieveTwo for reimbursement there or just any other dynamics on data collection?
Yeah, so we owe MolDX some more data. They've given us some feedback, and we're preparing additional data to submit to them. We do not have to wait for AchieveTwo. AchieveOne will be sufficient for us to launch. That completes our validation. That is our accuracy study, so in addition to accuracy, of course, we have all the other studies: limited detection, mass input, precision, interfering substances, and as soon as we've finished all of them, then we are prepared to commercially launch.
Great. Maybe moving to Pharma R&D services. I think, Luke, you talked about maybe adding some headcount there, talked about some potential partnerships in the pipeline. Can you talk about whether these partnerships fall more in the discovery side, data licensing, the profiling services, and then where this headcount is going and how you see that business taking shape in 2026?
Yeah. I think we're very excited about it. It's going to be across all three pillars, to be honest. So obviously getting our tissue FDA approval, we should be expanding our CDX platform. And that's a couple of the deals that we're working through right now that hopefully will materialize in the first half of the year. From a data perspective, again, we were late to the game because that's not been our focus. It's always been more clinically focused and focusing on the technology. But with that one million profiles and obviously the majority of those being whole exome and whole transcriptome, we believe we have a great platform that can help others develop new drugs or develop new targets based on utilizing our data. So we're working across all three pillars. So that's where we expect to see the growth from.
Obviously, from a financial metric standpoint, the data business is the higher gross margin product because, again, we made the commitment to run Whole Exome and Whole Transcriptome through our clinical business. So that's already embedded in our gross margin. But I think across the board is where we should expect it. And it's the same with the headcount. It's going to be across the three pillars.
Great. Maybe going back to molecular profiling on ASPs, which were very strong in four Qs, some true ups there, but still ex true ups stepped up nicely. Can you talk about how negotiations there are progressing with commercial payers? Where are typical rates falling around that Medicare price of $84.55? And then I think during the three Q earnings call, David Halbert put out a target of around $4,000 in the first half of this year. So any updated view on that target and just the level of visibility there would be helpful. Thanks.
Yeah. I think I was the one that said that. I don't want David talking about ASP. I want to focus on the technology. Yeah. From that standpoint, I feel like we're in a great place there. Our market access teams and our billing teams have done a fantastic job over the last kind of 12 to 18 months just getting prepared for when we got the FDA approval. So that's why you saw that kind of quicker than expected uptick. I think from my standpoint, one of the key things we've been able to communicate with payers is the comprehensive approach. So a lot of companies out there will run DNA, they'll run RNA separately, they'll run other tests separately, and they bill separately. This is one complete whole exome and whole transcriptome, and it's one bill that we're sending to them.
And we also include, and we don't charge for our AI signatures on top. And one of those signatures is, oh, I have to wrap up. One of those signatures is GPS, which if you were to charge for that separately, it's about $3,500. So they're starting to see that when we explain it to them that this is actually better for you in the long run by getting one test, one bill, and it's the most comprehensive that you don't go back and do multiple tests after.
Great. I think with that, we're out of time. So thank you to the Caris team. Thank you all for coming. Enjoy the rest of the conference.
Thank you.