Participants

Michael Brophy; Chief Financial Officer; Natera Inc

Steve Chapman; Chief Executive Officer; Natera Inc

John Fesko; President, Chief Business Officer; Natera Inc

Solomon Moshkevich; President - Clinical Diagnostics; Natera Inc

Alexey Aleshin; General Manager - Oncology & ECD, Chief Medical Officer; Natera Inc

Douglas Schenkel; Analyst; Wolfe Research, LLC

Rachel Vatnsdal; Analyst; JPMorgan Chase & Co.

Tejas Savant; Analyst; Morgan Stanley & Co LLC

Puneet Souda; Analyst; Leerink Partners LLC

Catherine Schulte; Analyst; Robert W. Baird & Co. Inc.

Daniel Brennan; Analyst; TD Cowen

Dan Leonard; Analyst; UBS Group AG

Subbu Nambi; Analyst; Guggenheim Partners, LLC

Presentation

Operator

Welcome, everyone, to Natera's 2024 fourth-quarter financial results conference call.
(Operator Instructions) As a reminder, this conference call is being recorded, today, February 27, 2025.
I would, now, like to hand the call over to Mr. Michael Brophy, Chief Financial Officer. Please go ahead, sir.

Michael Brophy

Thanks, operator. Good afternoon. Thank you for joining our conference call to discuss the results of our fourth quarter of 2024.
On the line, I'm joined by Steve Chapman, our CEO; Solomon Moshkevich, President, Clinical Diagnostics; John Fesko, President and Chief Business Officer; and Alex Aleshin, General Manager of Oncology.
Today's conference call is being broadcast live via webcast. We will be referring to a slide presentation that has been posted to investor.natera.com. A replay of the call will also be posted to our IR site, as soon as it's available.
Starting on slide 2.
During the course of this conference call, we will make forward-looking statements regarding future events and our anticipated future performance, such as our operational and financial outlook and projections, our assumptions for that outlook, market size, partnerships, clinical studies, expected results, opportunities and strategies, and expectations for various current and future products, including product capabilities, expected release dates, reimbursement coverage, and related effects on our financial and operating results.
We caution you that such statements reflect our best judgment, based on factors currently known to us and that actual events or results could differ, materially.
Please refer to the documents we filed, from time to time, with the SEC, including our most recent Form 10-K or 10-Q and the Form 8-K, filed with today's press release. Those documents identify important risks and other factors that may cause our actual results to differ, materially, from those contained in or suggested by the forward-looking statements.
Forward-looking statements made during the call are being made, as of today, February 27, 2025. If this call is replayed or reviewed, after today, the information presented during the call may not contain current or accurate information. Natera disclaims any obligation to update or revise any forward-looking statements.
We will provide guidance on today's call but will not provide any further guidance or updates on our performance, during the quarter, unless we do so in a public forum. We will quote a number of numeric or growth changes, as we discuss our financial performance. And, unless otherwise noted, each such reference represents a year-on-year comparison.
And, now, I'd like to turn the call over to Steve. Steve?

Steve Chapman

Thanks, Mike.
Let's get to the highlights, on the next slide.
2024 was a transformational year for Natera. And I think the Q4 results demonstrate that we ended the year with a lot of momentum, coming into 2025.
Revenues, in the quarter, were $476 million, up 53% year on year and $4 million above our January pre-announcement of $472 million. Volumes were up 26% compared to Q4 of last year and included an excellent showing for Signatera unit growth.
I'm pleased to report that gross margins, in the quarter, were 63%, which is significantly above the 51% we posted, just one year ago, and highlights the progress we made on both COGS and realized pricing in 2024. Finally, we generated roughly $46 million of cash flow in Q4, wrapping up the full year with about $86 million in total cash flow generation.
On top of the financials, we discussed a series of milestones across the business, in the last few months. We announced our innovation roadmap and shared several impressive data sets at the ASCO GI Conference, in January. Most notably, we announced the 80702 data in colorectal cancer that underscores the predictive abilities of Signatera. We also had our first readout in early cancer detection. And we are excited to share some additional data on that program, on today's call.
In Women's Health, the Green Journal published our clinical validation study for a fetal RhD test, which demonstrated excellent test results. We also have two meaningful novel studies coming down in Organ Health, later this year, that we look forward to discussing, today.
We are also pleased to see NCCN strengthen its position on cell-free DNA testing across several tumor types, as well as an expansion of the Medicare coverage for patients with stage 1 through 3 lung cancer. This makes Signatera more accessible to a population, with a significant unmet need for risk stratification and recurrence monitoring.
Great. Let's jump into some of the business trends, on the next slide.
As discussed in the pre-announcement, volumes exceeded expectations in Q4, with strengths across the portfolio. These longer-term [slides] really highlight the progress we've made in just a few years, with Q4 volumes up more than 2.5 times since 2020.
In Women's Health, we delivered very strong organic growth, as we continued to deliver a stream of new features and data sets. This was augmented by the Invitee win, which helped as well. Organ Health volumes were up almost 50% year on year, as volumes continued to ramp across the portfolio.
Of course, Signatera had a transformational year, with clinical volumes up approximately 60% versus Q4 2023 and nearly 15,000 units of growth over Q3 of 2024.
Looking back over 2024, we can see, in retrospect ,that the 24-month overall survival data presented at ASCO GI, early last year, proved to be a critical catalyst for broader adoption and early returns suggests that the three-year overall survival data presented at ESMO is having a similar impact.
We will spend more time on the 702 data, later in the call. But the feedback has been positive. And, in Q1, we're, once again, tracking to one of our strongest volume quarters ever for Signatera.
Total revenue growth continued to accelerate, as well, in Q4, which came in above our pre-announcement, as I mentioned at the top of the call. Volume growth has also been strong. But revenues grew almost twice as fast as volumes as our ASPs continue to improve across the board.
Signatera clinical ASPs improved to roughly $1,100 in Q4. And we continue to see steady progress for both Panorama and Horizon ASPs.
We launched a significant effort, in late 2022, to better secure reimbursement for all the covered services we provide, including significantly increasing staffing and automation tools. Those efforts continue to bear fruit in Q4 and give us confidence in modeling ASPs for the 2025 guide, as Mike will discuss later in the call.
We're excited about our ASP increases, thus far. But, looking at several years out, we think we have the potential to double the revenue from the volumes we are already running, today, as we expand coverage and reimbursement.
While ASPs have continued to climb, the cost of goods sold per unit has continued to fall, driving the significant improvement in gross margins in 2024. We had about a 3% true-up benefit to margins in the quarter, which represents excellent execution from our team in driving receipts above prior estimates. Even stripping out those true-ups yields a gross margin of 59% in Q4, which is another record for the company.
While we do have a number of initiatives, on TAP, to reduce costs further in 2025, I'm very pleased that the major cost projects that have consumed significant R&D resources of the last few years are, now, launched, which frees up resources to focus on delivering new products, features, and clinical evidence.
As we ramp revenues and gross margins, we've been able to generate cash, even as we began to increase investments in our platform. This longer-term [slide] shows the evolution of the company since early 2022, when we were making investments that are, now, generating significant benefits for both our patients and shareholders.
While the $46 million in cash flow represents a significant new record for Natera, it's worth noting that we actually made an approximately $20 million asset ,acquisition during the quarter. So I'd argue the operational cash flow, in the quarter, was approximately $65 million in Q4.
On our current trajectory, we could begin to generate meaningful cash flows in 2025. I think the last two quarters have been a critical case study in the efficiency of our business model and the ROICs we are, now, seeing on investments in R&D and SG&A.
The major clinical trials we're running, the new features we are launching, and the investments we are making to further refine our service to patients and physicians are translating to additional volume growth. And our traction on gross margins makes every new unit increasingly valuable.
So we want to take advantage of our position by taking the cash flows we're generating and reinvesting them in the business, in 2025. We feel, strongly, that this approach has the potential to enhance the growth profile of the business, in 2026 and beyond.
Part of these investments have been in teams tasked with expanding payer coverage and unlocking new insights from the massive amounts of data we generate every day.
I'd like John Fesko to, now, expand on each of these initiatives. John?

John Fesko

Thanks, Steve.
Within our core business, we have a significant potential opportunity to unlock reimbursement from test volumes that we're already running. And we've had several promising wins on this front, recently.
Many of you have seen that we secured a strong increase in our Medicare ADLT rate, this year, which was driven by strong pricing achieved in our commercial contracts. Steve also touched on the new MoIDX decision to cover Signatera and NSCLC. Based on the written requirements of the ADLT regulations, we believe no other MRD test is eligible to receive ADLT status, unless they obtain FDA approval.
We are also, now, seeing formal policies from commercial health plans announcing coverage for state-mandated biomarker legislation. Effective January 1, 2025, a leading benefits management company, who supports a large number of health plans across the country, published a formal policy detailing cancer biomarker mandates, across 20 different states.
Additionally, a top 5 national health plan updated their own medical policy, in Q4, to reference state coverage mandates. Additional plans have also begun coverage. And we're hopeful that others will follow suit.
I will caution that we still expect ASP improvements from biomarker laws to flow in, gradually, over time. But these are early winds that we can build on.
Within our Women's health business, we also saw numerous plans to add policy coverage for expanded carrier screening, including a large national payer and several large Blues plans.
We also saw the first meaningful Medicaid coverage and expanded carrier screening, with a published policy in one of the largest state Medicaid programs. Many other states have added expanded carrier codes to their fee schedules. We're excited about the momentum we're seeing here.
Steve touched on the time and investment we've put into our operations to get reimbursed for covered services and the positive impact that's had on revenues, margin, and cash flow.
We're, now, deploying new tools based on artificial intelligence to drive further improvement. Natera has developed AI tools to identify errors on claims, to spot patterns and denials and take corrective action, to scan payer response letters, and to develop custom patient-specific appeal letters. We're spending significant time and effort to refine these AI tools, with initial focus on driving quality. We are very excited about what's possible, here.
This is just one of many examples of how our team is deploying cutting-edge AI and Large Language Models to optimize productivity and business operations. It's only scratching the surface of how we are deploying AI to improve our customer experience, to optimize the performance of our core products, and to identify new prognostic and predictive signatures from our vast trove of clinical and genomic data.
We believe we have one of the largest cancer exome databases in the world, with over 200,000 cancer exomes and genome sequenced, many of which are in early-stage cancer patients, both tumor and germline. So we have a great opportunity to leverage that database to further improve patient care.
2024 was a good year, from that perspective. We generated meaningful revenue from our data initiatives and we expect to build on this effort in 2025.
We're pleased to report that we've already signed over $10 million in data-related contracts, this year, to have some positive early momentum.
Okay. With that, let me hand it over to Solomon to review some recent clinical trial results and product updates. Solomon?

Solomon Moshkevich

Thanks, John. Good afternoon, everyone.
First, I would like to provide an update from the Women's Health side, on our non-invasive fetal RhD test, where we continue to see growing demand and adoption.
We were pleased to see the publication of our clinical validation study in the Journal of Obstetrics and Gynecology, in November. This was the largest study of its kind performed in the US, to date. It demonstrated excellent performance, with sensitivity of 100% and specificity of 99.3%.
The study provides compelling scientific evidence on the ability of our tests to identify fetal RhD status and demonstrate its potential to assist patients and clinicians in the prevention and management of RhD alloimmunization.
Thanks to the growing base of evidence, together with guidelines from ACOD, supporting the use of fetal RhD testing in certain patients, adoption among eligible patients has been strong. And we were pleased to see commercial coverage initiated by one of the largest payers in the country.
This new policy, which became effective last month, expands access to fetal RhD testing that can significantly improve precision medicine during pregnancy. Building on this successful launch, from last year, we look forward to additional products and feature announcements, later this year, in Women's Health.
Transitioning now to Organ Health, I want to share some details on two unique studies on Prospera that we expect to readout in the coming months. And we believe will have a meaningful impact on the field.
The first is the PEDAL study, which is the first-of-its-kind prospective clinical trial of kidney transplant patients. It is designed to evaluate the dynamics of donor-DNA monitoring during treatment of a rejection event. This is similar to the cancer setting where circulating-tumor-DNA monitoring, with Signatera, for immunotherapy response has become an important use case. We expect that Prospera-based therapy monitoring will also have utility for organ transplant recipients dealing with a rejection event.
Incomplete resolution of rejection remains a significant risk factor for long-term graft survival. And, up until now there has been limited research into this area. With the PEDAL study, we hope to address whether on-treatment monitoring with Prospera can aid clinicians in understanding resolution of rejection and the risk of ongoing injury and whether discrete trends are associated with outcomes, at one year.
Ultimately, understanding how each patient is molecularly responding to treatment may allow physicians to make dynamic adjustments to the treatment plan.
Enrollment in the study included more than 580 patients, across 28 leading sites in the US and internationally, including UCLA, Cleveland Clinic, WashU, Mayo, and more. Patients were monitored with Prospera for eight weeks, following rejection, with tests performed at two-week intervals in the rejection cohort and clinical outcomes assessed to 12 months.
We've submitted the results for peer-reviewed publication. And we look forward to sharing those results, once they're available.
We are also outlining, here, a second novel study for Prospera. This one, for heart monitoring. The DEFINE study is a large-scale perspective, multi-center longitudinal study of donor-DNA in heart transplant patients that evaluated more than 100 patients and over 1,000 time points. The objective for DEFINE is to assess serial donor-DNA dynamics, along with serial endomyocardial biopsies and their association with clinical outcomes in the first year, after heart transplant.
It's the first of its kind longitudinal study, we believe, and the first to evaluate the dynamics of Prospera's unique two threshold-collar, using the donor quantity score, in conjunction with serial biopsies. And all compared to outcomes, at one year.
The DEFINE study is being submitted for publication. So we look forward to a readout, later this year. We believe this can make a meaningful impact on the standard of care in heart transplant monitoring.
Turning, now, to Oncology. The first big news is that we announced Medicare coverage of Signatera, for serial recurrence monitoring in non-small cell lung cancer, including stages 1, 2, and 3, and including both resectable and non-resectable diseases. This coverage was secured based on three peer-reviewed publications, showing the validity and utility of Signatera in lung cancer.
We think the coverage is important for several reasons. First and foremost, there's a significant unmet need for lung cancer patients in the surveillance setting. Timely detection of recurrence is a core principle of care, but serial imaging has limitations in sensitivity and specificity and it's often hard to interpret, especially after surgery and radiation.
Additionally, this is the first time we have secured reimbursement in stage 1 disease, based on the strength of our data, in that setting. Lung cancer is a lethal disease, hard to treat, where even stage 1 patients have a five-year rate of recurrence. That is higher than the rate of recurrence in stage 2 and 3 colorectal cancer.
Finally, this coverage expands on Signatera's pre-existing coverage for immunotherapy monitoring, where immunotherapy is already commonly prescribed in the adjuvant setting, as well as in the neoadjuvant and metastatic settings for non-small cell lung cancer.
We look forward to working, more closely, with the thoracic oncology community to improve care and outcomes for patients with lung cancer.
Looking beyond lung cancer, now, to the NCCN guidelines. We were pleased by the recent guideline updates, which, for the first time, included ctDNA in management guidelines of colorectal cancer, as well as merkel cell carcinoma. These updates are a significant validation of our Signatera clinical data strategy, as well as the core strength of our technology.
The inclusion of Signatera, every three ,months for surveillance of merkel cell carcinoma is a big step forward for the management of this rare but aggressive form of skin cancer. The guidelines, specifically, reference the peer-reviewed publication about Signatera, from a study that was initiated several years ago and published last year. Adoption in merkel cell carcinoma has been strong.
Additionally, we were pleased to see Signatera included in the guidelines of colon and rectal cancers -- specifically acknowledged as a high-risk prognostic marker in the aggregate setting.
Based on the initial positive feedback from physicians, we believe these recent guideline updates will support the use of Signatera in more CRC patients than before and likely to support adoption by new physicians.
It's worth noting that this language in colorectal cancer was discussed and voted on by the Committee, in the early fall of last year, before the publication of key data sets, including the overall survival data from the GALAXY study, the surveillance data from the BESPOKE study, and the predictive data from the CALGB/SWOG 80702 study. We believe this recent data has the potential to support further guideline updates in the not too distant future.
Now, I will turn it over to Alex to discuss the data, in greater detail, and our product roadmap in Oncology. Alex?

Alexey Aleshin

Thanks, Solomon.
I want to start by highlighting the CALGB/SWOG 80702 study, the results of which were presented in an oral session at this year's ASCO GI Conference. Signatera was utilized to examine, in a pre-specified manner, the tumor and plasma from around 1,000 stage 3 colorectal cancer patients.
In this randomized cohort, the results found that in Signatera-positive patients, the addition of celecoxib -- the standard adjuvant chemotherapy -- resulted in a three-year DFS improvement and a reduction in all-cause mortality of over 40%. Signatera in negative patients, by contrast, had no significant improvement in overall survival from receiving celecoxib.
The results were very well received by the scientific and clinical community, with multiple leading GI oncologists already telling us that they have started discussing celecoxib with their stage 3 patients, who test Signatera-positive.
This also represents another major proof point -- along with the IMvigor010 data in bladder cancer, published back in 2021 -- that Signatera can be predictive of therapy benefit, across multiple cancer types and drug classes.
We look forward to publishing the study, later this year.
We expect 2025 to be a pivotal year for Oncology business, with multiple significant clinical readouts, as well as expansion of our product portfolio.
Before reviewing our new product launches, I wanted to spend a minute discussing the underlying technology that powers and differentiates our MRD product offerings.
Over the past 15 years, Natera has developed, patented, and optimized a multiplex-PCR NGS technology that allows for deep and targeted detection of tumor-derived mutations in plasma, resulting in exquisite sensitivity and specificity, while controlling costs.
While our technology can multiplex thousands of targets, simultaneously, as we do with Panorama NIPT, for example, we believe the best approach for tumor-informed MRD detection is to select a targeted set of the highest-quality clonal variants, where Natera has significant experience, using proprietary methods.
Also, to optimize the primer design and the amplification protocols to sequence these targets at extreme high-depth of over 100,000 reads per target. And, then, to deploy a calling algorithm, based on our proprietary error model.
Some competitors have tried to replicate this approach but have been enjoined from using our patented multiplex-PCR technology. And so, have been forced to go a different route. For example, by using hybrid-capture technology.
MRD labs who use hybrid-capture, typically, track hundreds or thousands of targets but sequence them at a shallower NGS depth to control COGS. This is why MRD test performance depends on much more than, simply, the number of targets tracked. The technology truly matters. This is why Signatera's clinical performance remains outstanding for detecting a recurrence, in published clinical studies.
This debate of targeted and deep versus wide and shallow is similar to the early days of NIPT, where Natera deployed a deep, targeted SNP-based strategy, based on multiplex-PCR NGS, competing with shallower shotgun-sequencing techniques. And we all see how that played out.
While Signatera design on exome continues to be the assay of choice for the vast majority of oncologists, with over 100 peer-reviewed studies supporting its broad clinical utility and emerging predictive claims, we are also, now, receiving positive feedback on our genome-based product, launched at the end of last year.
Early interest from both the pharma and academic community has been strong for the role this product can play in clinical trials, in certain clinical situations. We'll be presenting clinical data from our genome assay, this year.
Furthermore, we're excited to make progress on our tissue-free assay, with launch expected in mid-2025 and with promising data presented in ASCO GI, several weeks ,ago showing competitive performance. Right now, in the lab, we're processing a large-scale prospectively collected study of over 1,000 samples that will support the launch of the tissue-free assay in the adjuvant and surveillance settings.
We believe that evidence will support reimbursement by Medicare. And we will follow, quickly, with applications and other cancer types.
With that, let me turn it back to Steve to discuss early cancer detection. Steve?

Steve Chapman

Thank you, Alex.
As we previously shared at J.P. Morgan, we presented our first prospective validation of our ECD technology, showing 95% sensitivity and 91% specificity, with minimal degradation of performance in the asymptomatic screen-detected population.
We continue to make rapid progress on this program. And I'm happy to announce that we've confirmed our CRC sensitivity in another independent data set, where the majority of patients were stage 1 and 2. We are encouraged by these results in CRC and look forward to reporting out a more definitive study, later this year, for the proceed trial.
The big announcement, for today, is the readout of our prospective advanced adenoma trial. As a reminder, we've collected roughly 3,000 patients, using a protocol similar to what we would use in an FDA-enabling trial. All samples were asymptomatic patients and collected prior to a screening colonoscopy.
We're pleased to report that in the patients analyzed for the study, we found an 18% sensitivity for advanced adenoma, with a specificity of 91%. Because of the manner in which these samples were collected, we don't expect to see the type of performance degradation that's been observed in other ECD trials.
Based on the excellent results in CRC and advanced adenoma, we decided to kick-off the FDA-enabling DEFINE study, which is expected to enroll, over the next 18 months. The perceived study has allowed us the opportunity to better estimate both the possible enrollment rate and the cost of the definitive study.
We believe this improves the chances for executing the study on schedule and within budgeted costs. This is already baked into our guidance for the year and has limited to impact on our cash trajectory.
Finally, as we look at the overall opportunity, we're pleased to see the Medicare rate confirmed at 920. And given that we will seek FDA approval for this test, we believe ADLT pricing, at a higher level, is possible. This elevates the opportunity for Natera, which is exciting, given our mission to help as many patients as possible.
For distribution, we're considering partnering with the national distributor or using our direct sales channel or a combination of both. Directly, we believe, today, we are already covering nearly all female patients through our OB-GYN channel and all major hospital systems through our strategic accounts team. We can augment this with sales reps in select markets for a solid distribution strategy.
We also think the idea of partnering is enticing, as well, either as a standalone strategy or alongside our direct team. In either case, we can do this without significantly impacting our operating expenses.
With that, I'll pass it back to Mike to review the financials. Mike?

Michael Brophy

Great. Thanks, Steve.
The first slide is just a summary of our Q4 financials. If you look at the year-on-year change column, to the right, you'll get a sense of the progress we made across every metric of the business.
As Steve covered, at the top of the call, the large increase in revenues, with even faster growth in gross margins, moved the P&L to a different level in 2024. Even as we made substantial investments in future growth, our loss per share narrowed, significantly, and we generated a meaningful amount of cash.
You'll recall that we retired the convertible notes, early, in Q4, so that leaves us with just under $1 billion in cash. And, effectively, no debt on the balance sheet, aside from the relationship line of credit, from UBS.
Okay. Let's get to the 2025 guidance, on the next slide. Steve touched on the revenue guide, at the top of the call.
We are pleased to be guiding to $1.87 billion to $1.95 billion in revenues to start the year off. Our base assumption for this guide is really just having the positive trends we've been seeing the last few quarters continue rolling into 2025.
That means steady volume growth and stable ASPs in Women's Health; continued market share capture and in-market growth and Organ Health; and, of course, we expect Signatera to continue to grow sequentially.
We've also, obviously, seen Signatera clinical volume, now, grow consistently above the 8,000 to 10,000 sequential unit growth threshold we've previously set as a target. The guide presumes we will modestly outpace that 8,000 to 10,000 level in 2025.
The guide does not attempt to forecast any revenue true-ups. While we think the true-ups represent good execution on cash collections, the fact that they can be lumpy and unpredictable means that we will just guide based on what we think the underlying business can deliver.
Consistent with our philosophy, we are setting this guide at the beginning of the year, acknowledging that we have several meaningful sources of upside potential. For example, those of you that have followed us for a long time know that for us to guide to stable ASPs in Women's Health is a fairly bullish signal and we are cautiously optimistic that we could actually see continued growth in Women's Health ASPs, this year, through our own organic efforts, as John described.
We haven't spent a lot of time dwelling on ACOG guidelines, recently. But, of course, if we get either a 22q or expanded carrier screening, that would be another great upside outcome. And the feedback we get on both continues to be positive. t
Solomon covered some of the extremely impactful clinical trial results we have on TAP and organ health and accelerated adoption of both Renasight and Prospera, on the back of those data readouts, would be upside to the guide.
Of course, the pace of adoption and realize pricing of Signatera, in the clinical setting, offer the largest potential sources of upside to the model, this year. Between the three-year overall survival data from CIRCULATE, the [Celebrex] readout at ACO GI, sales and operations currently executing at a very high level, and significant additional investments flowing into the business, we've never been in better position to change the way cancer is treated in the United States.
The guide presumes some modest ASP growth for Signatera, consistent with better allowed rates and Medicare Advantage, but does not require any significant level of traction with either NCCN guidelines or with biomarker state reimbursement.
We remain cautiously optimistic. We could see some green shoots in the results in the second half, from biomarker laws. And, of course, we will do everything we can to broaden Signatera adoption.
The gross margin guide presumes continued progress above the 59% gross margin we posted in Q4, ex the true-ups. The margin growth can come from several sources, and much like the revenue, we believe there are several sources of upside to the guidance. For example, better-than-expected realized pricing in any of our major products.
A note of caution on the gross margin is that we are launching these two complimentary products in the MRD menu, neither of which have optimized unit economics.
Our model presumes some modest uptake of both tumor-naïve MRD and the genome backbone product. And we expect this volume to be largely additive to core Signatera volumes, as existing customers avail themselves of the menu, from us, on a broader set of their patients.
If uptake from either offering exceeds our expectations, that would create a short-term headwind for margins. But I would argue that uptake is a very healthy signal for the longer-term development of the Signatera franchise.
As Steve covered, the SG&A and R&D lines demonstrate that we are not taking our foot off the gas in pursuit of innovation, great clinical trial results, and customer service across our business. We could hold expenses completely flat in 2025 and it wouldn't affect our growth, at all, in 2025 or 2026. Indeed, if you look back to 2023, we held expenses approximately flat, that year, and still grew revenues 32%.
We are already seeing high [ROCEs] from investments we made in early 2024. And we think every dollar we invest in our platform, now, puts us further ahead of the field for years to come.
Steve unveiled some very promising ECD data, today. But the spend in early cancer detection, this year and this year, is incremental to the core mandate we have to deliver the best possible offering to our patients and our core products.
We will remain focused on ensuring we are getting excellent returns on these investments. And we are going to manage the business with the goal to deliver a cash flow positive result, again, in 2025.
Okay. One more slide, just to put the revenue guide in its proper context.
As I mentioned, we are not guiding to any true-ups in the 2025 guidance. Although, we will likely have some true ups, as we continue to drive reimbursement from appeals on older test volumes. As ASP growth moderates, I do expect true-ups to moderate, as well. And I think the simplest framework for understanding quarterly progress is to review the results with the true-ups stripped out.
Accordingly, when you remove the true-ups from the 2024 results and, then, evaluate the guide on an apple-to-apple basis, you'll know that the implied revenue growth rate is roughly 24% at the midpoint. While this growth is much faster than most other businesses operating at our current scale, we are setting this guide as a starting point, with the goal of exceeding this target through the course of the year.
Okay. With that, let's open it up for questions. Operator?

Question and Answer Session

Operator

(Operator Instructions)
Douglas Schenkel, Wolfe Research.

Douglas Schenkel

Hey. Good afternoon. Thank you for taking my questions. I think a couple of questions, following-up on your prepared remarks.
Steve, in your prepared remarks, you talked about -- I think it was the ability to double Signatera revenue at the current level of volume, over the next few years. Just, maybe, dumbing it down for me as a math person, cutting through all of that, does that mean that you would expect to, potentially, get Signatera ASPs up to around $2000, over the balance of the decade?
And, then, I guess one for Solomon. You talked about the rationale behind why more targeted approaches have resonated on the clinical side with Signatera. Obviously, that continues to resonate. That said, some pharmaceutical companies have indicated they want a broader panel. How is the introduction of your genome-based products resonating with pharmaceutical and biotech customers, in the early going? And how is that factored in the guidance?
Thank you.

Steve Chapman

Yeah. Thanks, Doug. This is Steve.
First, on the ASP or on the revenue per test, I think the idea is, today, there's a significant number of tests that we process, where we don't get paid by the insurance companies. And that's baked into the average ASP that we show you, guys, when we're talking about ASP.
So as time goes on, as we get more coverage policies in place for things like, expanded carrier screening, other tumor types, commercial coverage for Signatera, we think we could see the revenue per test effectively double, as we start to get paid for some of the tests that we run, today.
They are already baked into our COGS but we're not getting paid on it.
And so, the comment I made was more general, about the business, overall. But it also really does hold true for Signatera. And I think your math is reasonable, as you look out into the future.
Then on -- I'll briefly comment on the genome side and, then, turn it over to Solomon. Certainly, there's some interest from pharma and in a select areas -- some clinical providers. I think the product's been received very well. Largely with the idea of using it for clinical research.
But, at this point, if the doctor wants a genome, pharma company wants the genome, we have it available. And the product performs exceptionally well. So we're excited about it.
Solomon, you want to make any further comments?

Solomon Moshkevich

Sure. I'll add that there are situations where we do research projects with pharmaceutical companies or academic consortia, where they seek to answer more translational or researching questions of interest. And we routinely run custom versions of our technology that can include hundreds of targets, if that's something that the customer wants.
Generally, we think about building a product for the clinical setting that's going to become a workhorse and highly-scalable and, also, cost efficient. So I think that's where you're seeing attractive levels of adoption, in the clinical setting.
We do think about these (inaudible) the end products, a little bit differently, for those different settings. But the underlying core technology, leveraging multiplex-PCR, we think provides the advantages across both of those settings, depending on the application type.
And, increasingly, we're able to add more services and more genomic insights from our analysis of the tissue -- whether that's with the genome or an exome and from the normal DNA -- and being able to run additional side assays, like RNAC, for example. So there's a lot that we're able to do.
Hopefully, that answers the question.

Douglas Schenkel

Yes. That was great. Thank you, guys.

Operator

Rachel Vatnsdal, J.P. Morgan.

Rachel Vatnsdal

Perfect. Thank you. Good afternoon, you, guys. Thanks for taking the questions.
First up, here. Just on Signatera, if we look at the volume growth that you saw throughout 2024, you did roughly 14,000 sequential unit growth throughout last year. You said you're going to do above that 8,000 to 10,000 per quarter or sequential per quarter in 2025.
But can you just give us some more color on how much above you could do versus that 8,000 to 10,000? Like the old-long term plan that you, guys, have had. And, then, could it be something in that range of 14,000, like we saw last year?
And, then, I have a follow up as well.

Steve Chapman

Yeah. Thanks for the question. I'll let Mike comment a little bit on the guide.
But, first, I'll just say we're very under penetrated. This is a very large market. We generated over 100 peer-reviewed papers and we're seeing very significant interest from physicians. And that interest is accelerating, as we generate data like the 702 study. That really provides an actionable, predictive use case for the product.
As we said in the prepared remarks, Q1 volume growth and Signatera is looking to be one of the best quarters that we've ever had, in the history of the company. So we're feeling very good about volume growth in Signatera.
Mike, you want to comment on how we do the guide?

Michael Brophy

The guide -- we covered, on the philosophy, in detail, and the prepared remarks.
So the guide presumes that we can do better than the 8,000 to 10,000. It's not necessarily anchored at 14,000. It's going to be -- it wouldn't surprise me if you just look at last year, averaging out, you're in that 13,000 14,000 range.
But, obviously, the lumping you had -- 15, 000, you got 11,000 -- wouldn't surprise me if you have those types of typical fluctuations through the course of the quarters.
And that's really more driven by just, different numbers of receiving days that are available to you, in a given quarter. So I think the spirit of the guide is that the momentum continues.
And it's you know it's a strong but, still, an achievable target, as a starting point for the guide of the year.

Rachel Vatnsdal

Great. Thanks for that color. Then, I just wanted to dig into the concept of true-ups, here, as well.
You mentioned that you're not including true-ups within the current guide for 2025. You've also talked about how the magnitude of those true-ups are going to come down, as you guys continue to do better on collections and have more visibility in that.
So could you just level set for us: What should we expect in terms of that true-up getting more standard, as we go forward in the trajectory, there, over the next few years?
Thanks.

Michael Brophy

The reason why we have true-ups is that the historical cash collections are exceeding the historical accruals. And, as we get history with better and better cash collections per test, obviously, the accrual increases in [sympathy], okay?
And so, invariably, that's going -- the change in the ASPs, in these products, is going to moderate. And when it does for a period of time, you'll have the troops decline on a glide slope. So I do think that they'll moderate, over time, back to what we thought, historically, which was, like, a 5 million troop number, every quarter.
The reason why we don't guide to it though is that that's hard to predict, quarter to quarter. I'll just give you an example. I mean, we're working very hard to win appeals on cases that we ran in the fourth quarter of 2023. So we've already collected 100% of the revenue that we needed to collect for 2023 Q4.
But if we win more of those appeals, the cash arrives in Q1 or arrives in Q2, then, we'll book revenue in that period. So fully expect it to be lumpy. But you've seen the ASP go up quite a bit. And I expect, over time, on average, those to moderate down on a, more or less, linear glide slope.

Operator

Tejas Savant, Morgan Stanley.

Tejas Savant

Hey, guys. Good evening. Thanks for the time, here.
Just to start, maybe, one for Alex, here. I know, in the deck, you talked about the number of targets only being one variable impacting tumor-informed MRD assay performance. But how many markers do you anticipate tracking for your personalized whole genome panels, that's the 16, like the current version of Signatera? And how did you think about that choice, in terms of cost considerations versus optimizing for, perhaps, higher sensitivity?
And can you just share some early color on feedback from the oncologist community?

Steve Chapman

Yeah. Let me make a couple comments and, then, throw it over to Alex.
Yeah. On the genome product, we're tracking 64 variants. And, remember, we're using the same and multiplex-PCR NGS approach that we use for the 16-variant assay.
The philosophy is to go extremely deep at a very highly-curated targeted set of variants. So we think that's the best approach.
We could do 2,000 variants. We actually do 30,000 variants in a single reaction, when we run certain tests. We do that all the time in the laboratory. But we chose, specifically, to do 16.
And, now, in this case of genome, 64, because we think that's the right approach, where you're optimizing sensitivity and specificity. And I think that's proving to be the right decision.
If you look at our clinical performance data, you look at our very strong data that we published for recurrence monitoring, it's really good. So this looks like to be the right approach. And we're excited about it.
Alex, you want to comment further?

Alexey Aleshin

Yeah. Maybe, just one or two quick points.
I think the first is we've seen really very positive and very strong feedback with this launch, both from the broader academic community, the consortia community, as well as the pharma community. So we're very pleased with that.
And, now, the way we think about it, as Steve mentioned, is there's a few factors that go into asset performance. Number of variants is just one of many.
So error model is super important. The quality of the variant selected. And, then, the ability to sequence and call those variants very deeply.
And I think when we did the math, 16 was really the optimal number for exome. And when we did the math for genome, at least, initially, the number is 64, that optimizes performance across those metrics, while keeping COGS contained.

Tejas Savant

Got it. That's helpful. And, Mike, a quick follow-up on the guide, for you.
First, how are you thinking about any potential benefit from the NovaSeq X transition?
And, second, on the Medicare lung reimbursement for Signatera, any color you can share, in terms of pair mix, Medicare versus commercial and non-small cell lung? And how many deaths will be covered in the surveillance setting?

Steve Chapman

(multiple speakers)
Let me comment on lung, Mike. And, then, you can, maybe, jump in on the COGS projects that we've executed on.
But, obviously, we're really positive on lung. We're seeing a lot of interest, there, from providers. That's an area where, historically, we did really well, engaging with the KOLs and some of the top centers. But we weren't reimbursed so it wasn't necessarily, I think, the first thing that our sales representatives and medical team were talking about, when they were out in the field.
But, nevertheless, we still have a lot of volume coming through. There's a lot of interest. So this is a big opportunity for us, as we look at, just, the number of patients that are diagnosed -- I think the clinical importance of this type of testing and the value that we can provide from surveillance --
I think this represents a new vector of growth for Natera, that could, potentially, even help us push, significantly, past, maybe, some of the record volume quarters that we saw in 2024.
Mike, you want to talk on COGS projects?

Michael Brophy

Yeah. So, just, first, since we're on lung, I think the Medicare mix is going to be broadly similar to the average that we see across the business, there. So I do think it it'll be a contributor. Similar to the rest of the tumor types, there's not, like, a very meaningful skew, I think, within that Medicare mix.
Similarly, I presume that there will be -- now, that we have the coverage, we'll go back and just confirm on the pricing decisions with MoIDX. But I think it's safe to presume that similar setup, in terms of a bundle. Pricing would be the standard, there, for the admin setting.
In terms of the GOGS projects, we definitely we're going to have some improvements to COGS, I think, here in '25. And that's part of the guide. That's part of the gross margin improvement that's contemplated in the guide -- pretty meaningful gross margin improvement versus the underlying 59% we just posted in Q4.
I think Steve's comments and prepared marks were more -- it used to be -- up until middle of last year, it was really -- the overwhelming thrust of the R&D effort, we were forced to prioritize just getting these COGS projects out the door.
And, now, we can be a lot more nimble and focused on some interesting product launches and features and data sets. So it's a much more balanced portfolio.

Tejas Savant

Got it. Appreciate the color, guys. Thank you.

Operator

Tycho Peterson, Jefferies.

Hey. This is [Nolan], on for Tycho. Thanks for taking our questions.
Wanted to start by asking about the 702 study and particularly interested in what the initial reaction's been like, there? Anything you would point out as an indicator that this will lead to broader use from clinicians?

Steve Chapman

Yeah. Thanks for the question. I'll make a comment and, then, maybe, hand it over to Alex or Solomon, if they want to comment further.
But any time you have something like this, it's very actionable for the doctors. There's going to be significant interest, particularly when it has that predictive impact, as well.
And I can just ,say from my view, coming out of the conference, one of the leading colorectal physicians came up and said, hey, look, I've already started prescribing celecoxib in my practice to MRD-positive patients, based on this data.
So I think -- to hear that really gave us confidence that this is very important and it's going to change practice.
Alex or Solomon, you, guys, want to comment further?

Solomon Moshkevich

No. I think the -- initially, feedback is overwhelmingly positive. I think there's also -- additional data was presented to ASCO GI about the benefit of aspirin in some early stage colorectal cancer patients.
I think that further reinforced this concept that [COGS] to inhibition, especially when biomarker-directed, can be very impactful for these patients.
And, just to put this in the context, there's not been a new therapeutic development in the adjuvant management of colon cancer for over 20 years since the MOSAIC study. So I think because of this -- I think patient advocacy groups, physicians -- I think there's just broad excitement across the board.
And we'll see how this translates into further guideline changes. We can't predict that. But looking forward to see what the NCCN Committee may weigh in on this data.
That would be coming from my side.

Thanks.
And, then, one more, from us. On MRD, obviously, a number of competitors will be launching in the next year. So just wondering what your competitive strategy is in order to try to maintain the market-leading position, there?
Thanks.

Steve Chapman

You know, there's always been competitors coming in. I think a couple of them have been enjoined because of our IP position. But for the last couple of ,years there's been competitors selling MRD testing in the market marketplace, clinically.
So we feel like we're in a good position. You have to just do the fundamental things: you have to deliver high-quality clinical data; you have to have an amazing customer experience; you have to have a strong medical, commercial team. And we're continuing to do that.
The other area. This is innovation. And I think we're in a very strong position because we're able to invest, very significantly, in R&D. And you can see we're not burning cash; we're cash flow positive.
We're at one of the highest levels of R&D spend that we've been at. And that's because we think there's a lot of opportunities for product line extensions, product line enhancements, new versions of products. And, most importantly, big, large-scale, market-moving clinical trials.
So we're doing all those things. And we think we're doing the right things. But competition is a good thing too. It's great to see that this market is very meaningful and that it's growing.
And it's what, like, 3% penetrated or something like that? So this is, probably, the largest molecular diagnostic opportunity in the history of oncology molecular diagnostics. So, certainly, there's going to be a lot of competitors coming in.

Operator

Puneet Souda, Leerink Partners.

Puneet Souda

Yeah. Hi, guys. Thanks for the questions, here.
Maybe, first one. On the cadence, can you remind us, maybe Mike, how should we think about growth through the year? You have a number of drivers. Obviously, data reading out, products launching, and, on top of that, John talked about a number of ASP drivers. So just trying to understand how to think about Q1 and the cadence through the year?
And the gross margin lift that you have in the guide was also strong. Is that largely ASP? Or how much COGS reduction are you thinking about?
Again, looking at both Oncology and Women's Health.
And I have a follow-up.

Michael Brophy

It's a good question on the cadence.
Typically, in the Women's Health business, I actually think that we'll return to our normal form, there, where Q1 is a very strong quarter for Women's Health. Just, seasonally, Q2 tends to be softer. And, then, you return to Q1 levels and beyond, in Q3 and Q4.
Last year, the cards were scrambled a little bit just because we added those [VK] units. And that was straddled between Q1 and Q2 so you didn't quite see that trend in the financials, this year.
But this is a pretty clean year. From ads, as far as that's concerned. I think Women's Health returned to the normal seasonality we've seen over the last decade.
Signatera and Prospera, there's not really a seasonal component, there, other than the dynamic that I mentioned earlier in the call, which is just, say, number of receiving days will vary and where to scale, particularly Signatera, where every receiving days is worth a lot of units. And so you just got to keep that in mind. Holidays will impact.
But that's the (inaudible) for us. (inaudible) Q1 bigger because of Women's Health; Q2 is softer because of , again, seasonality in Women's Health, and, then, return to form in the second half of the year. And not much seasonality in the Organ Health and Signatera.
Sorry, you asked about, gross margins?
I agree with you. Look, I think that's important to think about -- the gross margins. The guide -- actually, it does imply very bullish outlook, as it relates to continued gross margin improvement. And I do think that (technical difficulty), there are some projects that are going to deliver in '25 that I think will be useful.
We're also just going to get some benefits on the COGS side, just from the scale efficiencies -- that you grow units the way that we're growing them, you do get a linear benefit to all the facilities and all the equipment and the people and things like that.
And we're getting more and more efficient there. So that's a component of it. I do think that waiting them -- there's more of a waiting toward benefits in ASPs. So that's the continued growth in the Signatera ASP.
And, also, just steady execution Women's Health ASPs continuing on where we left them in Q4. And, then, annualize them for a full year would get you a strong uplift.
But that does leave you room for upside, and John alluded to some of the potential source of upside we have, particularly in Women's Health ASPs.

Puneet Souda

Got it.
And, then, if I could, I'll try my best with this question on NCCN. But we're also getting questions on the advanced adenoma data that you provided in the slide deck.
So NCCN ctDNA is prognostic but not predictive. And, then, they also said ctDNA is not recommended for surveillance. I appreciate the merkel cell support that you're getting there. But could you elaborate on the oncologist feedback?
And, one side, there's the traction with pairs, potentially. But, on the other side, there's also the offset, maybe, in the community setting. The oncologists are still going to be looking for NCCN. So, maybe, just help us capture the NCCN and how you're thinking about that?
And, just, on advanced adenoma, why should we not see any degradation there?
Thank you so much.

Steve Chapman

Let me just comment, briefly. And, then, maybe, Alex, you can make a couple comments on advanced adenoma.
But on NCCN, it's being received very positively. There's been a lot of good feedback on the calls that we've done and meetings we've had, over the last two weeks. I think, certainly, an adjuvant was an enhancement.
And, as Solomon pointed out in the prepared remarks, some of the data that I think is very meaningful, like for example, the 702, couldn't be considered. Where, maybe, you would have received that predictive claim. But, certainly, that's an enhancement.
And on surveillance. It's we think it's just administrative language cleanup. That's some of the feedback we've been getting -- is there was no real intention, there. And that makes sense. And that's in line with what we're hearing out in the field, as well. So we don't think it will have any impact.
There's also great surveillance data. INTERCEPT, which is -- more and more people are talking about that, now, out of MD Anderson. A very significant trial. And, then, the BESPOKE study was received very positively at ASCO GI. So, certainly, we think that's going to have an impact, as well.
But I would say net NCCN readout was very positive for us.
And then on advanced adenoma, I'll turn it over to Alex on advanced adenoma. Alex?

Alexey Aleshin

Hey, Steve.
I think this is our first readout. I think what makes us more comfortable to really think that we're minimizing the chance for a degradation, as much as possible, is that these are samples that are collected prospectively, colonoscopy-matched in the screening population -- really following the same ethos as our prospective FDA-enabling study, that Steve announced that we're launching, shortly.
And, again, this is the first of what we hope to be multiple readouts, also, for advanced adenoma. I think we're planning an additional readout, later this year. Again, following the same ethos of only running prospectively-collected colonoscopy-matched samples, following a very similar protocol to the FDA study.
And the good news is that we still have a little bit more time before the algorithm has to be completely locked, right? So we do also think there could be room for further improvement, beyond the number that we initially read out.
So those are the things we're doing to try to minimize the chance of degradation, as much as possible.

Puneet Souda

Got it. Helpful. Thank you.

Operator

Catherine Schulte, Baird.

Catherine Schulte

Hey, guys. Thanks for the questions.
Maybe, first, on biomarker bills. Is there any way to frame what your success rates have been in getting paid in those states, to date? How has that evolved once the bill becomes effective?
And, then, I know you aren't baking anything into guidance but how do you think those success rates could realistically evolve, over the course of the year?

Steve Chapman

Yeah. That's a good question.
I think the outlook on biomarker is positive. And it's great to see that we're seeing, I think, the first signs of the ship turning, here.
So let me turn it over to John Fesko to talk, just briefly, on what's happening there.

John Fesko

Thanks, Steve.
Catherine, we've been cautious on the impact of biomarkers because we didn't know the pace at which it would flow through. And it's taken a little longer than we had hoped for.
But, you know, with these formal publications, we think that creates ammunition to go press other plants. And we have heard from other plants that they want to come into compliance with the law.
So we think that we will see conservative positive improvement, over the course of this year and next year.

Catherine Schulte

Okay.
And, then, maybe, on R&D. Just given the magnitude of the increase you're calling for this year, can you just talk through the spend buckets within that Oncology versus Women's Health versus early detection? How much is the FDA-enabling study?
And, then, just how will be thinking about R&D growth, over the next couple of years? Or where that might settle out, as a percent of revenue, over time?

Steve Chapman

Yeah. I'll just make one more comment on the biomarker bill. This goes back to, I think, Doug's question at the beginning -- around our prepared comments that (technical difficulty) the revenue per test.
Biomarker bill is a great example because, today, we'll receive a test from a commercial parent and a lot of times, they don't pay us. And this is an opportunity, as the biomarker bill comes in, where we can actually get paid on some of the tests that we're already running.
So not only are we accelerating volume growth, as time goes on, by getting things like lung coverage in place and just the MRD market evolving but we also have this impact of accelerating ASP that's happening, over time. And the biomarker bill is a very significant opportunity for us.
R&D -- sorry, I just had to remember what the second question was -- on the R&D side, look, the vast majority of the R&D is going to be on MRD. And that's clinical trials; and that's product line extensions, product line enhancements; that's COGS and scaling-related projects; and that's [UX]-related projects.
When you look at other areas of the business, certainly, we think Women's Health and Organ Health are very important. We've got some pretty exciting launches happening there -- of those businesses, in the future.
And, also, some great clinical studies, as we went over PEDAL and DEFINE. These are, really, the first time these specific things have ever been studied in this very, rigorous prospective manner. And we think they can be very meaningful for the field.
But, yeah, the main focus is MRD, in oncology. And we think that's where we should be putting our investment, now.
Of course, the ECD opportunity. Although, traditionally, our investment there has been very targeted, we'll continue with that philosophy. Now, we're launching the FDA-enabling study. That's already worked into the budget, already worked into the guidance for the year. But there will be some spend there.
And we think that that's warranted, given what we think is really strong performance on the ECD product. And, given the ASP, I think the $900-plus Medicare clinical (inaudible) schedule rate, plus the opportunity to have an ADLT rate that could be in the $1,500 range, I think that, actually, makes it a very significant opportunity for Natera.
Given our ability to develop these types, work through the regulatory framework or historical success with distribution, and, actually, the built -in channel that we already have for distribution, we think we can be a very major player in that space. And we think we can do it without really significantly increasing the operating expenses and have a very high gross margin product.
Certainly, that's worth investing. And that's why we're putting money behind that.

Catherine Schulte

Great. Thank you.

Operator

Daniel Brennan, TD Cowen.

Daniel Brennan

Great. Thanks for the questions.
Maybe, just starting on price, Mike, just walk us through -- I think you said Women's Health price is flat in '25. So what are you assuming on the Signatera?
And, if you could let us know, on commercial payers, just what's the progress been there? And what are you baking in, implied in that price for '25, of commercial payers?
And then I have a follow-up.

Steve Chapman

Mike, you want to take that?

Michael Brophy

Thanks for the question.
On Signatera, we just expect steady continued improvement in the ASPs. Women's Health, as you mentioned, is stable.
What's going to drive the improvement in Signatera, at least in the base model, is just going to be continued execution on reimbursement for our Medicare Advantage volumes for covered services. So that's been an important, driver for Signatera ASPs, over the last 12 to 18 months -- is getting Medicare Advantage reimbursement from the 20% range to, now, in the high-60%s range.
And so, we're going to make steady improvement on that -- we fully expect in '25. And that's what gives us confidence to actually guide to improving Signatera ASPs, in the year.
And, then, again, the Women's Health ASPs have been really strong. We've been very encouraged by the results we've gotten from all the hard work, there. So that's certainly a potential source of upside, if we can continue to see improved ASPs, particularly in expanded carrier screening. That would represent upside to what we've guided, today.

Daniel Brennan

Great.
And, then, maybe, just to follow-up on lung. Can you just remind us what percent of the lung indication you have, today, wasn't covered by [IO]? Of the 200,000-plus incidents, how many of those patients are already applicable for [IO]? So what's, like, the expansion that you see?
And any other approvals we could expect, this year? Which tumor types are high on the list?
Thank you.

Steve Chapman

Solomon, you want to comment on how things are parsed out between, maybe, the adjuvant indication and lung, where we were already covering quite a few of the patients with [IO] monitoring? And, then, what is this very large surveillance opportunity that we just received coverage for?

Solomon Moshkevich

Sure. Thank you.
In lung cancer, immunotherapy is already very commonly prescribed, even in early stages of disease. In many patients, in the adjuvant setting, in the early stages. And some patients also in the neoadjuvant settings -- so that's before surgery. And some patients get both.
So Signatera was already covered for immunotherapy monitoring in those patients. And that would be a single-bundle payment. When a patient is starting monitoring for immunotherapy, the new coverage, it provides -- the new Medicare determination provides coverage in the surveillance setting.
So this is for patients who complete their definitive therapy, who will have no more evidence of disease. And in line with NCCN recommendations for monitoring in the surveillance setting, Signatera can, now, be used as well, and paid for by Medicare.
So we think that's a big deal. We think it's in line with the evidence and in line with the opportunity for greatest impact for those patients.
In terms of other disease types, we've published, now -- in many additional cancer types, we have several submissions that are currently in progress and others that are being prepared that -- the draft-off of the evidence that's been established and published. So looking forward to provide further updates, there.
And thanks for the question.

Daniel Brennan

Great. Thank you.

Operator

Dan Leonard, UBS.

Dan Leonard

Great. Thank you for running long.
I'll ask a two-parter on early cancer. First off, can you clarify the timing? I think you mentioned 18-month trial. So does that mean we'll get data by the end of 2026? And you'd hope for a 2027 FDA-approval, if all goes well? That's the first part.
And the second part. Can you touch on the platform capability? Is this a platform where you could add other cancers as well, on the same format? Or would any future multi-cancer offering be a different technology platform, entirely?

Steve Chapman

Yeah. It's a great question.
I think that the timing is probably about right. Alex or Solomon, if you want to provide any more specifics, there?
But I think, roughly, in the right ballpark. The good news is -- with the trial, we set up this entire infrastructure, PROCEED study. So we already had collected, prospectively, 3,000 samples, there. We worked with different vendors to run the trial.
And so we're basically just flipping a switch and moving into the new trial, with the same infrastructure. And I think that's going to allow us to get it done, I think, quickly and efficiently. And, as Alex said, we learned a lot through I think the 3,000 patient-PROCEED trial.
On the platform that we built, I think you're exactly right. We spent two years building a Discovery platform that allows us to identify novel markers. And we're just pumping new data through that and using that to design assays, now, in this pan-cancer approach.
Now, we're still assessing our strategy for the next version -- of where we want to go after CRC. And we think that the right approach is focusing on CRC, initially. But, certainly, as we said in tumor-naïve MRD, we're already moving to other tumor types.
And I think in the field of early cancer detection, there's going to be that opportunity to do the same thing, based on the strength of the platform that we built.
Thank you.

Operator

Subbu Nambi, Guggenheim.

Subbu Nambi

Hey, guys. Thank you for taking my question.
Two questions. One, could you elaborate on why you believe no one else will receive ADLT status? One could argue a first-in-class tumor knife test, for example.
And, then, second, how much of an advantage is having a biobank, with all the Signatera samples to develop a tumor-naïve and screening tests that you just touched upon, then?

Steve Chapman

Look, I think if you go through -- I would just point you to go through the ADLT regulation. There's multiple tumor-naïve MRD tests on the market. And that's one of the disqualifiers for an ADLT: without FDA approval.
So I think there's several commercial (inaudible)-validated on-market tumor-naïve products. And if you go through the specific legislation, that, itself, is a disqualifier for a new ADLT approval.
Now, of course, there's the FDA path. But that takes time. From a sample collection standpoint, this is one of the real values of Natera and you start to see -- remember, we've been at this since 2015.
We started collecting biobanks. We started doing prospective clinical studies. We started collecting samples. So when it comes to launching new products in the MRD space or new versions of the product, we have a real advantage because we published over 100 peer-reviewed papers. And we have over 100 ongoing clinical trials and bio-based and studies that we're participating in. So we're in -- like we said, in tumor-naïve.
For colorectal, we already have a prospective1,000-patient sample, covering surveillance in the adjuvant setting. It's already running in the lab, today. So I think that just gives you a sense of how quickly we can execute on things.

Subbu Nambi

That's great. Thank you, guys.

Operator

Everyone, that does conclude our question-and -answer session, as well as our conference for today.
We would like to thank you all for your participation. You may now disconnect.