BillionToOne, Inc. Q3 FY2025 Earnings Call

BillionToOne Third Quarter 2025 Earnings Call. Please be advised that today's call is being recorded. I would now like to hand the call over to your speaker today, David Deichler, Investor Relations. Please go ahead.

Good afternoon, everyone. Thank you for participating in today's conference call. Joining me on the call from BillionToOne, we have Oguzhan Atay, Co-Founder and Chief Executive Officer; and Ross Taylor, Chief Financial Officer. Earlier today, BillionToOne released financial results for the third quarter ended September 30, 2025. A copy of the press release is available on the company's website. Before we begin, I want to remind you that during this call, we may make forward-looking statements within the meaning of federal securities laws. Such statements about future events may include statements about our financial outlook and performance, market size, products and services, reimbursement coverage, future clinical performance and other statements. We caution you that such statements reflect our current best judgment, and actual results may differ materially from those expressed or implied in any forward-looking statements. Risk factors that may cause our results to differ are discussed in our filings with the SEC, including our previously filed registration statement on Form S-1, our quarterly report on Form 10-Q to be filed following this call and the current report on Form 8-K filed today. Any forward-looking statement made during this call is made as of today, December 9, 2025. If this call is replayed or reviewed after today, the information made during this call may not contain current or accurate information. BillionToOne disclaims any obligation to publicly update any forward-looking statements, whether because of new information, future events or otherwise, except as required by law. And with that, I'll turn the call over to Oguzhan.

Thank you, David. Good afternoon, everyone. Thank you for joining our third quarter earnings call. Today marks our first earnings call as a public company, and we look forward to continuing a dialogue with the investment community as our business grows in the years ahead. In November, we completed a successful initial public offering on NASDAQ, raising $314 million in gross proceeds for the company. I'd like to start this call by thanking our dedicated and hard-working employees, along with our shareholders, all of whom made this substantial milestone possible. A new chapter for BillionToOne is just beginning, and I am excited for our future as a public company. At BillionToOne, we have four pillars of differentiation that we believe makes us a different type of molecular diagnostics company. Everything that we do starts with a revolutionary single-molecule next-generation sequencing platform. This is enabled by our patented QCT, quantitative counting template technology, which achieves single-molecule level sensitivity and precision. With our technology, we have built unique category-defining products, both in prenatal and oncology. In prenatal, we are redefining what it means to do non-invasive prenatal testing with our UNITY products by enabling a more efficient and more sensitive test to help mothers understand health status of their developing babies. In oncology, we offer Northstar Select to help guide therapy selection across multiple indications and Northstar Response, which helps physicians monitor the patient response to therapies. Both our prenatal and oncology products are highly differentiated and have a direct impact on critical decision-making for patients. Our unique technology and product portfolio have led to exponential growth rates even as we reached $334 million in annualized revenue run rate or ARR in the third quarter. That said, we believe that we are just scratching the surface of what is possible. With our smNGS technology, we believe that we are uniquely positioned to address more than $100 billion in the U.S. market opportunity over time. Importantly, having a unique technology and differentiated products allowed us to achieve a superior gross margin profile, achieving 70% in Q3 2025, even with subscale ASPs and using only about one-quarter of our current lab capacity. We believe that we have significant opportunity for further ASP growth and COGS per test reductions, both in our prenatal and oncology product lines. Last but not least, I am perhaps most proud of our capital and operational efficiency, which have allowed us to achieve emerging profitability while growing at over 100 percent, an unprecedented feat in molecular diagnostics. As I shared with the private and public investment community over the last five or more years and throughout the IPO roadshow, our long-term goal is to build a category-defining generational company and become a member of the S&P 500. Our third-quarter performance and achievements allowed us to continue to make important strides towards this goal, and the results are simply stunning. Our revolutionary smNGS platform and products continue to be validated by publications and partnerships, including two prenatal publications, a head-to-head study on Northstar Select, and an exclusive agreement with Johnson & Johnson, all of which I will cover on the next few slides. On revenue and test volume front, we continue to scale rapidly as we reported 51% test growth and 117% revenue growth year-over-year in the third quarter. Gross margins were a remarkable 70%, a 17 percentage point expansion from last year due to robust outperformance in ASPs and continued reductions in cost per test. We were able to achieve this growth with emerging GAAP profitability, reporting an 11.5% positive GAAP operating margin and bringing all year-to-date GAAP profitability metrics to be positive. Ross and I will take you through our quarter in more detail, but I'd first like to provide you with an update on a few exciting publications and business developments. We have recently had impressive prenatal and oncology publications in peer-reviewed journals. Notably, the largest study of cystic fibrosis in any prenatal setting published in the Journal of Cystic Fibrosis demonstrated 100% sensitivity for UNITY in identifying high-risk cystic fibrosis pregnancies. Importantly, 95% of these cases were eligible for cystic fibrosis modulator therapies, highlighting the clinical utility of our approach. Another UNITY publication in pregnancy validated the clinical utility of fetal antigen cell-free DNA testing and highlighted the advantage in providing precision to pregnancies that are at risk for hemolytic disease of fetus and newborn, or HDFN, which UNITY provides. Finally, we also finalized an exclusive agreement establishing us as the official companion diagnostic partner to Johnson & Johnson for hemolytic disease of fetus and newborn. This positions our UNITY Fetal Antigen test for treatment of HDFN as the first CDx of its kind in the NIPT space, and we have successfully met all milestones to date. Turning to oncology. Northstar Select demonstrated superior sensitivity in a prospective head-to-head validation study published in the Journal of Liquid Biopsy. In this study, we asked clinicians across the country to use whatever liquid biopsy that they are using for standard of care. But for the same patient on the same day as part of the same blood draw, send us another tube of blood as well. We did not prescribe what test they should use. We did not create inclusion/exclusion criteria. And at the end, we reported our results and other liquid biopsy companies reported their results. Here, we show that in this head-to-head study, we detected 51% more pathogenic SMVs and 109% more copy number variants versus these competitors. These publications further validate the transformative nature of UNITY and Northstar tests. With these differentiated products, we have been able to drive rapid growth. Our rapid growth is becoming even more impressive as our organization scales. In Q3 2025, total tests accessioned in the quarter grew 51% year-over-year to 163,000 tests. Strong test volume growth was driven by expanded geographic coverage by our growing commercial team as we enter new markets and increased commercial density in existing markets while expanding in-network status with commercial payers. We have also seen acceleration even with larger health system adoptions, which was one of the drivers of our growth. We believe that the competitive product launches for fetal risk assessment validate the market need that we identified more than five years ago. Given the significant technology differentiation, more than five years of peer-reviewed publications, and significant product advantages we have, we haven't seen any impact on our business so far as it can be seen in the growth that we achieved in this quarter and until today. It's also important to note that we have achieved this phenomenal growth without having invested as significantly in EMR. That said, as we are seeing more of our growth to start to come from broad health system adoptions across the United States, we decided to invest more heavily in this area. As such, we have signed the contract with Epic for Aura implementation. While this may take nine months to become live, once live, we believe this will remove one of the biggest impediments to faster UNITY adoption in health systems across the United States. Total revenue in Q3 2025 was $83.5 million, which was an increase of 117% compared with $38 million in the third quarter of 2024. Our results in this quarter were driven by robust test volume growth, along with expanding average selling prices or ASPs across all products, drivers of which I will discuss in more detail shortly. Exceptional performance across every metric drove sequential growth of 25% from the second quarter. ARR of $334 million represents an approximately $69 million increase sequentially compared to ARR in the second quarter, highlighting the demand for our tests and the general momentum of our business. This outperformance was driven by rapid growth in both prenatal and oncology revenues. In the third quarter, prenatal revenue was $74 million, representing growth of 101% year-over-year. The oncology business is growing even faster than our prenatal business, delivering $8.7 million of revenue in the third quarter, growing 664% compared to the third quarter of last year. The revenue performance was driven by rapid test volume growth of both Select and Response tests as well as improved ASPs. We have seen tremendous growth in oncology over the last two years from when we first launched our Northstar products and continue to expand our oncology sales team as we grow. We believe there exists a large opportunity for Northstar in the future with expanded coverage decisions, especially for Response to support meaningful revenue opportunities in the years to come. Our superior gross margin profile is driven by both expanding ASPs and a reduction in cost per test. Overall blended ASP was $501 in the third quarter, a remarkable increase of 44% year-over-year, and a sequential quarter-over-quarter growth of 10%. The primary drivers of ASP growth have been expanded payer coverage in prenatal as we grow our commercial contracting efforts to where we now have approximately 235 million contracted lives. We have also brought reimbursement in-house last year, and our team is continuing to make strides towards getting more of our tests to be paid. Finally, we have seen more Medicaid loading and covering the UNITY Carrier panel PLA code, which has contributed to incremental ASP improvement. We continue to expand coverage for specific parts of our test as we continue to drive ASP improvement over time. In addition to driving ASP growth, we have remained committed to our operating philosophy of continuous improvement to reduce the total cost per test. In the third quarter of 2025, our blended cost per test decreased by 10% to $151, primarily driven by our cost initiatives and increased volumes driving fixed cost per test lower. This decrease came despite an increasing shift to a higher proportion of revenues coming from oncology, which, of course, has higher COGS per test as well as higher stock-based compensation expense as we move towards being a public company. As overall COGS has decreased and overall blended ASPs have increased, gross margins have rapidly expanded. Our gross margins were 70% in the third quarter compared to 53% in the third quarter of 2024, a remarkable 17 percentage point increase. Since our earliest days, we have been highly capital efficient, prioritizing spend with purpose and focusing on efficiency. We expect to maintain the same disciplined approach to investment and growth to drive profitability as we continue as a public company. With that, I will turn the call over to Ross to review our financial results and provide 2025 guidance before I conclude.

Thank you, Oguzhan. As Oguzhan noted, total revenue in the third quarter of 2025 was $83.5 million compared to $38.4 million in the third quarter of 2024, representing an increase of 117%. Furthermore, revenue growth for both our prenatal and oncology product lines was strong in the quarter. Our prenatal revenues consisting of both our clinical testing revenues of $74.1 million and roughly $800,000 in revenues from clinical trial support and other services increased just over 100% to $74.8 million in Q3. Our oncology revenues increased 7.6 times to $8.7 million in Q3 of 2025 compared to the same period last year. And oncology revenues increased 76% sequentially from $4.9 million in Q2 of 2025. Our total revenue growth was driven primarily by test volume growth across both prenatal and oncology as well as expansion of our prenatal and oncology ASPs. Our total revenues included true-up revenue resulting from higher cash collections related to tests delivered in prior periods. True-up revenue was $3.7 million in Q3 of 2025 and $8.7 million for the nine months ending September 30, 2025. In comparison, true-up revenue was $1.4 million in Q3 of 2024 and $10.2 million for the first nine months of 2024. Excluding true-up revenue, total revenue growth in Q3 was 116% compared to the same period last year. Gross profit in the third quarter of 2025 was $58.4 million, compared to $20.2 million in the third quarter of 2024, resulting in a gross margin of 70% in the third quarter of 2025 and 53% in the third quarter of 2024. The increase in gross margins was primarily attributable to increases in our overall ASP and a decline in our overall cost per test. I will note that ASPs and cost per test improved in all of our product lines this quarter. Total operating expenses were $48.8 million in the third quarter of 2025 compared to $32.8 million in the comparable prior year quarter, representing an increase of 49%. Within total operating expenses, R&D expense was $13.0 million in the third quarter of 2025 compared to $9.6 million in the comparable prior year quarter, while SG&A expense was $35.8 million in the third quarter of 2025, compared to $23.3 million in the comparable prior year quarter. We continue to scale our operating expenses to support rapid growth with efficiency and discipline. Operating income was $9.6 million in the third quarter of 2025 compared to an operating loss of $12.6 million in the third quarter of 2024. Our Q3 operating profit margin was 11.5%. Q3 2025 is the first quarter in which we achieved positive GAAP operating income, and it occurred more quickly than we expected as a result of the strong improvement in revenues and gross margins that we experienced in the quarter. We expect to operate our business such that we continue to generate positive GAAP operating income in the future. Net income available to common shareholders was $1.5 million or $0.10 per diluted share in the third quarter of 2025, compared to a net loss of $14.9 million or $1.47 per diluted share for the same period in 2024. Weighted average diluted shares outstanding used to calculate net income per share were 15.6 million shares in Q3 of this year. Cash flow from operations minus capital expenditures and investments was $7.9 million in Q3 of 2025 and $6.5 million for the first nine months of 2025. Net cash flow was $6.2 million and $3.7 million for the same periods, respectively. Following the upsized IPO and execution of the green shoe, diluted shares outstanding are expected to be in a range of 55 million to 56 million over the next several quarters for modeling purposes. Please note that weighted average diluted shares will be lower in the fourth quarter given that the IPO occurred in early November. Lastly, we are well capitalized with a very strong balance sheet. We ended the third quarter with approximately $195 million in cash and equivalents. Subsequent to the third quarter, we received approximately $314 million of gross proceeds or $286.4 million in net proceeds from our initial public offering. Our very healthy balance sheet positions us for strong growth moving forward, particularly given our intent to continue to manage the business for profitability and positive cash flow. Finally, I will provide our full year guidance for 2025. We expect 2025 total revenue of $293 million to $299 million, representing a remarkable growth of 92% to 96% compared to 2024. Embedded within this guidance is fourth quarter revenue expectations of $84 million to $90 million, which is growth of over 86% to 100% compared to the fourth quarter of last year. We note that despite Q4 historically being a seasonally slower quarter for our business due to fewer number of accessioning days in most of the larger clinics and health systems, preferring to push their switches from one laboratory to another laboratory in January, our business momentum remains strong in Q4. This is leading us to expect modest sequential quarter-on-quarter growth from Q3 to Q4 even after an exceptionally strong Q3 that had every single metric outperforming our expectations. At the midpoint, the year-over-year growth we are projecting for Q4 is the second highest year-over-year percentage that we expect to achieve since July of 2024, highlighting our continued momentum. Additionally, we expect positive GAAP operating income for both Q4 and the full year of 2025. I will now turn the call back over to Oguzhan to conclude.

In summary, BillionToOne has made substantial progress this year, including outstanding performance in the third quarter of 2025. Yet we believe our journey is just beginning. We are transforming health care, one molecule at a time, one patient at a time to build a category-defining company and become the first one in our space to enter S&P 500. As a summary, in this quarter, we have had new publications supporting the superiority of our test and technology. Our Q3 outperformance was across all key metrics, leading to the best quarter over last year. And we are continuing to make investments, both in the growth of our sales team and investment in areas such as EMR. This is resulting in guidance of a year-over-year growth of 10%, both for Q4 and full year 2025. I am very excited for the future of BillionToOne, and I'm confident in our ability to positively change the trajectory of millions of patients' lives. I will now turn the call over to the operator for the Q&A.

And our first question will come from the line of Mark Massaro from BTIG.

Congrats on your first quarter as a public company and on the IPO. So I wanted to start, it's nice to see the positive GAAP net income come in. I heard you talk about expecting that to continue to be positive in Q4. I am curious, is that also your plan to be positive in 2026? Now I recognize that you're ramping up some investments in the business, probably in oncology as well. So how should we think about 2026 GAAP net income or even adjusted?

Thank you, Mark, and thank you for your kind words. While we are going to be leaving the kind of exact guidance for 2026 to JPMorgan Healthcare Conference, I think we have iterated previously that it is our aim to continue to grow our company in a profitable way. That is a goal that I think we will continue to maintain for years to come.

Okay. Great. And then maybe on the oncology side, I recognize it's early days. But I'd be curious, I think you've got your first test reimbursed by Medicare, I think the second test. I would be curious, Oguzhan, how you're thinking about timing there? And then can you just give us a sense for how significant of an investment you're planning to make in 2026? I don't need dollars, but just conceptually from a strategic standpoint.

Yes. Thank you, Mark. We have already invested significantly in clinical studies for our Northstar Response coverage. We believe that we have already completed the studies that we need to be able to get coverage. We will be supplementing it with additional studies in 2026, but we believe that the first Medicare coverage for Northstar Response based on the timing of MolDX discussions and back and forth as well will come before the end of 2026.

And our next question will come from the line of Andrew Brackmann from William Blair.

Maybe just given this is the first time sending guidance as a public company, can you maybe just sort of talk about the overall process that you had in place for setting guidance? And I guess related to that, just the overall philosophy when it comes to sort of embedding conservatism or errand bars around the forecast year?

Thank you, Andrew. I think we have been operating close to a public company for the last two to three years now. As you may remember, we had even shared some of our projections back in JPMorgan earlier this year in the conference, both for actually 2025 and 2026. And as you can see from the numbers that we have been able to provide, we have been conservative in those projections. In general, I think our business has been very repeatable and predictable in general, but there are also a lot of tailwinds that we don't put into our models, especially with respect to ASP growth. So a lot of our test volume numbers are still conservative, but predictable, but then ASP increases tend not to be embedded into the guidance as much. So a lot of the tailwinds that we see with respect to increased coverage, increased contracting due to more of our tests getting paid result in outperformance compared to what we project. I would also note, though, we are almost to the end of this year. So the guidance that we are showing at least for Q4 and 2025 is actually relatively accurate.

Yes, I might just add. I think in some ways, the numbers we've put out for the Q4 guidance is somewhat analogous or similar to what we did with the Q3 flash numbers in the S-1. We tried to kind of bracket our expectations. So I think we put out a pretty reasonable guidance range for Q4.

I appreciate your insights. Regarding the investment in the EMR, I understand that it will take several quarters to implement. Conceptually, how should we think about the opportunity and its impact on your business? When you engage with customers, how much of those discussions are influencing this decision? Additionally, how should we consider the effects and potential outcomes that you might experience?

Yes. Thank you, Andrew. And this is an area that I think many of the analysts also have uncovered in their independent searches as well. This is an area that we haven't invested as heavily compared to other companies because it can be significantly additional costs to be able to do some of these; it can cost millions of dollars. But I think what we are realizing and recognizing is that as we get into more and more health systems, this actually becomes really the only impediment for getting very large volume health system accounts switched to us. So we believe that this is going to essentially accelerate our adoption in these large health systems pretty significantly once it is live. It is also something that we have been probably the only standout company that hasn't done this. So I think it is pretty remarkable that we have been able to grow without the existence of this, but really, this opens up almost about half of this prenatal market that has been previously much more difficult for us to penetrate that they really want those EMR integrations to be able to order this. As you know, especially in the prenatal setting, ease of use is critical. In fact, it is one of the value propositions of UNITY Fetal Risk screen. It allows a much easier way to screen for pregnancies for a very comprehensive set of conditions. But of course, not having EMR was essentially contradictory to that ease of use. So by being able to invest in here, I think we are going to get to parity with others, and that will really drive our continued growth at the rates that we have seen in the past.

Our next question will come from David Westenberg from Piper Sandler.

I echo the response. Congrats on the IPO and coming out of the gate strong here. So your clinical spending annually is somewhere around $50 million versus some of your competitors that are spending 10 times that. Do you think you're spending sufficiently? And how are you thinking about design in studies in oncology? We appreciate the data you gave about 51% increases in indels, SMVs and a copy number variation, et cetera, of 100%. But ultimately, your test is about finding more actionable mutations that get patients on the right therapy. Do you think that you could be running bigger studies, which may be say OS and disease-free survival? I would make an argument that you are like your competitors, building markets in this as well. So I know that was one question, but I have one follow-up.

Thank you for your question, Dave. We understand the importance of investing in clinical studies. However, when we invest in clinical studies, we aim to clarify the specific questions we are addressing and assess whether they will add value to what physicians are looking for. Regarding therapy selection, I agree that we have demonstrated more mutations, but our discussions with physicians indicate that they do not have concerns about whether this leads to improved clinical outcomes for patients. While we could conduct those studies, I believe they would not significantly influence the adoption rates we are experiencing in the well-established area of therapy selection. As we explore new areas like response monitoring and minimal residual disease (MRD), I believe more extensive studies and investment are necessary because these fields may not be as familiar to physicians. When they identify an EGFR or KRAS mutation, physicians generally understand that it can improve patient outcomes. However, the benefits of early progression detection or surveillance with MRD are not as clearly established, not just by us but across various diagnostic companies, especially outside of the adjuvant setting. Therefore, it's crucial to continue investing in these areas while being selective about which studies we pursue. We will increase our investments in MRD, but we need to focus on studies that genuinely address the questions oncologists have, which vary across different areas. While therapy selection may not rely on overall survival, response monitoring and MRD potentially might.

Regarding oncology, how do you perceive the balance between monitoring and therapy selection in terms of the number of tests conducted per patient? Additionally, could you elaborate on whether a doctor might utilize just one of your tests while opting for a competitor's test for others? I wouldn't imagine this to be very frequent, but could you discuss specific situations where this might occur? I'm trying to understand this balance moving forward and any potential factors that could influence it.

That's a great question. Since Response is a monitoring test, we observe approximately a 2:1 ratio of Response tests to Select tests. As mentioned during the roadshow, about 95% of our providers utilize both Select and Response together, making it uncommon for physicians to rely solely on either test. After using both tests, some physicians may repeat both Select and Response, while others may opt for more Response tests until they detect progression, at which point they would use another Select test. In terms of individual patients, we definitely see multiple uses of Select, alongside a 2:1 ratio of Response to Select. However, this can vary because different physicians have different practices; some may use Select exclusively, while others may follow up with Response and then revert to Select upon noticing progression.

And our next question will come from the line of Casey Woodring from JPMorgan.

Congrats on the IPO. I guess the first one, just curious on sales force expansion. Curious what the expectation is in terms of how many reps do you expect to hire in 4Q? And then any thoughts on how you expect to expand the sales force in 2026, both in prenatal and oncology?

Thank you, Casey. We have been consistent in how we grow our sales team. For our prenatal sales team, we add about 8 to 10 new representatives per quarter and approximately 4 to 6 or 7 in oncology each quarter. This can vary, but our approach to adding these reps has been steady. This consistency enables us to maintain an excellent service level and great turnaround times, with support functions also growing at similar rates. It allows us to select the best candidates, targeting the top 1%. While our sales efficiency metrics may suggest that accelerating growth could be beneficial, we believe that a methodical and deliberate approach has served us well so far. We intend to continue with this strategy going forward.

Got it. That's helpful. For my follow-up, you mentioned better traction with Medicaid for the UNITY Carrier panel code. How much did this contribute to ASP growth in the quarter, and how should we view that contribution in Q4 and beyond?

It is difficult to prescribe essentially one change to specific dollar amounts of ASP. But just to give you a sense of how important this can be, the carrier code, standard carrier panels versus our PLA code is almost a two times difference in where the ASPs are. So from that perspective, essentially, even a single Medicaid incorporating our PLA code into their coverage policy can be significant. And it is not just significant with respect to the state Medicaid lives that allows us to go then to manage Medicaid in that state and be able to add our PLA code to those contracts as well. So it does take a while for its full impact to be embedded into our ASPs, but it really sets a different, I think, long-term ASP goal for us as we essentially get more Medicaid covering our PLA code.

And our next question will come from the line of Brandon Couillard from Wells Fargo.

Ross, the 70% gross margin in the quarter, pretty strong performance. Do you expect that to be the new baseline as we look out exiting the year and into '26? And just talk about what additional areas you still see room to lower the COGS per test over the next year or two?

Yes. I don't think we're quite ready to talk about 2026 and gross margins, Brandon. But I think that you have an expectation that we remain somewhere in the high 60s is probably a pretty reasonable expectation for at least the next several quarters. I think you know that we do have a negative mix shift that we're confronting as the oncology products are lower gross margin but growing much faster. So that does create a kind of negative mix shift versus prenatal. So we had really nice gross margins in Q3, but I don't think our expectations have really changed for gross margin versus what we've talked about recently.

Yes. As a minor addition to that, Brandon, I think it really depends on the rate at which our ASPs grow, rate at which our COGS decrease, and in comparison to the mix shift. Our prenatal ASPs are growing, I think, quite nicely. Our COGS continue to decrease as we are using more of our lab capacity. That is particularly true on the oncology side as well. So if you look at each of these products, ASPs are growing, COGS are decreasing, and each gross margin is expanding over time. But given that our oncology revenue is growing faster, it essentially you have those opposing forces. So it really depends on exactly how fast the gross margin of each product continues to expand versus the growth rate of each of those products. But as Ross said, we expect to essentially maintain high 60s, low 70s as we continue to grow.

Okay. That makes sense. And then one clarification, Ross. Is there any true-up revenue that's embedded in the fourth quarter revenue guide? And then Oguzhan, as we just think about '26, can you just talk about the major data readouts or clinical or reimbursement milestones we should keep on the radar for next year?

Sure. Just on the revenue question, Brandon. During this year, the first nine months, our true-up revenues range between 3% and 5% of revenues. And I think our expectation would be that it's probably somewhere in that range in Q4 as well. So a small amount of true-up, I think, consistent with what we've seen this year.

And the question in terms of the readout, we are continuing to do our clinical studies, especially on Northstar Response. And in support of getting coverage for Northstar Response, I think the biggest milestone would be getting our first Medicare MolDX coverage for Northstar Response. So this is one of our big initiatives and big goals for 2026. And given that we have this two Response to one Select ratio, any increase in Response ASPs would be significant for both our oncology gross margins as well as our oncology revenues.

Our next question will come from the line of Tycho Peterson from Jefferies.

One of the common questions we've gotten post IPO was just on MRD and any timelines you can provide on when we can start expecting data, what indications you may prioritize and pursue, and what gives you kind of the right to win there? Can you maybe just touch on that as we think about the pipeline?

Certainly. I think the way that we think about MRD is that MRD is going to be split into two areas, especially over time, especially as we get out of colorectal cancer to other cancer types, tumor-informed and tumor-naive. And as you are seeing, I think, more and more, tumor-informed essentially is going to get very competitive. Essentially achieving a 1 to 10 PPM clinical LODs is going to be possible with many different methodologies, and these ultra-sensitive tests are going to be really competing with each other with good clinical data over time as well on the tumor-informed side. Our goal is to focus on the tumor-naive MRD. And there, actually, our technology solves the fundamental problem that forces all these different companies to actually focus on tumor-informed MRD. Why does anyone develop a tumor-informed MRD? Certainly, it is not the cheapest, and it is not something that the physicians want. It is more difficult to use. They do tumor-informed MRDs because if you know where to look at in cell-free DNA, you are going to be able to achieve these ultra-sensitive levels. Our technology, our smNGS, QCT quantitative counting template technology solve exactly this noise problem. Essentially, what we are doing is we are removing this noise that they are trying to remove by having a tumor-informed MRD. So from that perspective, we believe that we can achieve ultra-sensitive levels of sensitivity with a tumor-naive test that no other company has been able to get anywhere near until now. In terms of our data readout and approach there, which is going to be a pan-cancer assay, similar to our response monitoring approach that we have taken there. But of course, we will want to launch with data. So we are expecting the launch to be towards the end of 2026, essentially at around the similar times that we expect to get coverage for our response test. From our growth perspective, we have always had this philosophy of having only one test that doesn't have broad coverage and high gross margins. So once we have our response monitoring covered by Medicare, we want to launch MRD for a pan-cancer indication, but we, of course, know that we are not going to have coverage for our MRD at least for the first year of commercialization.

Okay, that's very helpful. And then on UNITY, I think you said certain parts could see expanded coverage. I assume that's on the carrier screening side. And any change on the competitive front? Obviously, we saw your competitor introduce the Fetal Focus assay. Any change you're seeing in the market today?

As I sit here on December 9, I see no impact on our business from competitive launches. In some ways, it is as if it didn't happen. So from that perspective, we continue to grow as expected. I think it is a good thing. In some ways, it can lead to guideline changes, more awareness, but we also have a significant lead in our approach here, in our ease of use, in the way that we are approaching this particular market. So, so far, no impact, as you have seen in the Q3 numbers and I think as embedded into our Q4 guidance.

I'm not showing any further questions in the queue. I would like to turn the call back over to Oguzhan Atay for any closing remarks.

Thank you, and thank you for all the questions. This was our first earnings as a public company. We are very excited about the future of our company and how we can continue to grow, continue to change standard of care, continue to create a different type of molecular diagnostics company that can combine hyper growth with profitability. We believe that we have shown how this is possible, and we are on a 20-mile march to show that a company in this space can even enter S&P 500. So thank you for all the questions and listening to us today, and we look forward to seeing you in future earnings calls.

Thank you for your participation in today's conference. This does conclude the program. You may now disconnect. Everyone, have a great day.