Good day and thank you for standing by. Welcome to the BillionToOne third quarter 2026 earnings call. At this time, all participants are in a listen-only mode. Please be advised that today's conference is being recorded. After the speaker's presentation, there will be a question and answer session. To ask a question, please press star 1 1 on your telephone and wait for your name to be announced. To withdraw your question, please press star 1 1 again. I would now like to hand the conference over to your speaker today, Gabby Gable with Investor Relations

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 30th, 2026. 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 meeting of federal securities laws. Such statements about future events may include statements about our financial outlook and performance, market size, our products and services, reimbursement coverage, future clinical performance, and other similar 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 annual report on Form 10-K, 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, November 4, 2026. If this call is replayed or reviewed after today, the information made during this call may not contain current or accurate information. MillionToOne 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 will turn the call over to Ozan.

Good afternoon, everyone, and welcome to our third quarter 2026 earnings call. Before I begin, I want to recognize the people who make our work possible. To the patients and providers who rely on us during the most important moments of their care, thank you for your confidence in us. And to our employees, your commitment is what allows us to deliver superior tests that lead to better care and remove the fear of the unknown for our patients. Before turning to our quarterly results, I would like to remind you of our four pillars that guide our strategy and set BillionToOne apart from other molecular diagnostics companies. The foundation is our first pillar. Our patented QCT, or quantitative counting template technology, has allowed us to create category-defining products in prenatal and in oncology. Those products drive our second pillar, scalable rapid growth. We have grown rapidly to $492 million annualized revenue run rate in just six years. But we also believe we have only scratched the surface with $100 billion of annual cell-free DNA testing opportunity in prenatal and oncology in the U.S. alone. Our third pillar is a superior gross margin profile, which together with relentless discipline on both ASVs and COGs, keeps our gross margin above 70% today, and we believe with more room left to expand in the long term. And our fourth pillar is gap profitability. The margin profile, paired with our fiscally disciplined culture and AI-enabled operations, has made us gap profitable and cash flow positive, with roughly one-tenth of the accumulated deficit of our public peers. Our long-term goal has not changed. We are building a generational company that transforms the standard of care in molecular diagnostics for millions of patients. In the third quarter, we executed on every one of our four pillars. It was another strong quarter. We delivered record revenue and a combination of rapid growth and gap profitability that remains exceptionally rare in molecular diagnostics, as well as the type of product and clinical study developments that can position us for exceptional growth and performance in the years to come. Briefly, pillar by pillar. In our first pillar, we published two important studies. First, in the leading journal for OBGYNs, the Green Journal, we published the first and only peer-reviewed prospective study in single gene NIPT. In oncology, in the Journal of Liquid Biopsy, we published what we believe is the first head-to-head study of a tissue-free test North Star Response against a tumor-informed assay for response monitoring with on par to superior results. And we are launching North Star Clear, our tissue-free MRD test, on December 15th, which I'll come back to shortly. On rapid growth, prenatal revenue was up 42% and oncology revenue was up 96%, resulting in total Q3 revenue growth of 47% year-over-year. Our gross margins remained very consistent in the quarter at 71%, even with Cox-Bertes rising 10% to $169 due to faster oncology growth. Lastly, we generated gap operating income of $11 million, a 9% gap operating margin, and a remarkable 18% adjusted EBITDA margin. It was our fifth consecutive quarter of positive gap operating income. We were also cash flow positive and finished the quarter with $562 million in cash.

Now, let me walk through each pillar in more detail.

Beginning with our first pillar, our SMNGS, platform and products. Clinical evidence is what turns a powerful platform into a standard of care. And this quarter, we meaningfully expanded that evidence across prenatal and oncology while preparing our next major product launch. Starting with prenatal, on August 18, we published the first and largest prospective study of a single-gene noninvasive prenatal test in its intended use population, validating it as a first-line screen. The study appeared in the leading journal for OBGYNs, the Green Journal, and was conducted in collaboration with nine U.S. institutions. This is exactly the kind of high-quality evidence that changes clinical practice. We obtained outcomes for more than 98% of the 2,212 pregnancies studied. Unity Fetal Risk Screen demonstrated 94.4% sensitivity and 99.5% specificity with consistent performance across a racially and ethnically diverse U.S. population. To put this in perspective, with traditional screening, the highest fetal risk a family can receive is 1 in 4. Unity provides a personalized fetal risk as high as 9 in 10 and as low as 1 in 10,000. Unlike other studies where most affected fetuses come from previously identified high-risk couples, this prospective multi-site study was conducted in the intended use general population with near-complete outcome collections. Therefore, it constitutes the highest form of evidence in showing that the assay works in identifying affected fetuses with high sensitivity and specificity. We believe this publication reinforces unity as the leading cell-free DNA screen for recessive single gene conditions. In Oncology, on October 7th, in the Journal of Liquid Biopsy, we published what we believe is the first head-to-head comparison with the most widely used tumor-informed assay in patients on active treatment for advanced cancer. This was a pan-cancer, real-world comparison, with the data coming from providers who use both assays in their clinical practice. The results show that NorthStar response delivers on par to superior results versus the tumor-informed assay, which, to our knowledge, makes this the first time a tissue-free test has ever demonstrated superior head-to-head performance against a tumor-informed assay. The two tests agreed on the direction of ctDNA change in 94% of sequential pairs. However, in all divergent cases, the patient's clinical records supported North Star responses findings, whereas the tumor-informed assays results were either false positives or false negatives relative to the patient's clinical response or progression. Tumors evolve over time, and this study shows that relying on a test that depended on years-old tissue can sometimes lead to inaccurate results. This study also shows that physicians do not need to trade away performance to receive the turnaround time and other logistical benefits of a tissue-free test. The study is a powerful demonstration of the precision that our QCT technology delivers, and it further strengthens the evidence base for NorthStar response. We expect this data to accelerate adoption of response and further ensure that the Medicare coverage for response is a matter of when rather than if. We are excited to announce that NorthStar Clear, our tissue-free MRD test, will be commercially launching on December 15th. Clear is a pan-cancer test and only requires a blood draw, so it is available for all solid tumors from day one with no need to wait for a tissue sample or build a patient-specific assay. What we set out to deliver with Clear is tissue-free MRD with tumor-informed performance. MRD represents an estimated $30 billion annual market, and we believe we have developed the most sensitive tissue-free MRD test. We will launch with head-to-head data against a tumor-informed comparator. While this head-to-head data will initially be in colorectal cancer, the assay will be available for all solid tumors. We will continue further evidence generation across all solid tumors through 2027 and beyond. Clear is also an important step in expanding our platform. Together with Select and Response, Clear means the Northstar portfolio will now span early and late stage care, all built on the same QCT technology. The work behind Clear also lays the groundwork for our longer-term opportunity in early detection. Fundamentally, a tissue-free MRD and early detection are very similar technical problems, with both requiring the detection of very low levels of tumor DNA without the benefit of tissue access. As such, our MRD launch significantly de-risks our long-term plans for a highly sensitive early detection test. Next, our second pillar, scalable rapid growth. In the third quarter, total test volume grew 25% year-over-year to approximately 206,000 tests, up more than 10,000 tests sequentially, and with sequential growth in both prenatal and oncology. There were three overall drivers to strong test volumes. Strong execution by our teams, a larger field sales force, and continued positive reception of the product enhancements we have introduced across both prenatal and oncology. In prenatal specifically, we are continuing our focus on pushing into larger health systems, which remains a large opportunity. This is supported by our newly launched 130 gene fetal risk screen, category-defining unity confirm test, and Epic Aura integration. In oncology, volume growth was exceptional again, driven by our expanding sales team and continued adoption of our PGX, CH, and tissue of origin enhancements. Both prenatal and oncology were significant drivers of growth in the third quarter. Prenatal revenue was $106 million, up 42% year-over-year, representing an annualized run rate of $424 million. Oncology revenue nearly doubled, growing 96% year-over-year to $17 million, representing an annualized run rate of approximately $68 million. Our total revenue performance in the third quarter reflects our ability to execute remarkable growth over the past six years. We have built a $492 million of annualized revenue run rate business from essentially zero in approximately six years. Together, prenatal and oncology draw a record total revenue of $123 million in the third quarter, up 47% year-over-year and 12% quarter-over-quarter. This growth was driven by 25% growth in test volume and 18% growth in ASB. Now to the third pillar, our superior gross margin profile. Turning to our ASPs in the quarter, overall ASP increased 7% sequentially and 18% year-over-year to $589 per test. Both prenatal and oncology ASPs increased quarter-over-quarter. Excluding true-op revenue, overall ASB was $552, up 3% sequentially and 15% year-over-year. This increase was driven by more payer contracts, higher reimbursement for RHD and IPT through its PLA code, and a growing proportion of oncology, which has a higher overall ASB than prenatal. Growing ASP is only half of the equation, with continuous improvement on Coxper tests remaining core to how we operate. Overall Coxper test was $169 in the third quarter compared to $161 last quarter, reflecting the continued mixed shift toward oncology, along with some transient costs from recent product launches. In oncology, COXPR test continues to improve, and importantly, North Star response is already at approximately gross margin breakeven. Because oncology is growing faster than prenatal, we continue to anticipate a gradual increase on overall COXPR test over time. Gross margin in turn was 71% in the third quarter, up approximately 1 percentage point from a year ago due to higher ASPs. Prenatal gross margin was 75%, and oncology gross margin increased to 45%, and that is even before any Medicare coverage for North Star response. We have maintained a superior gross margin profile even as oncology continues to keep growing much faster than prenatal. With ASPs continuing to rise in both prenatal and oncology, and with ongoing cost reductions in oncology, we believe we can sustain this profile as oncology grows into a far larger share of our business. With that, I will turn the call over to Ross to review our financial results and guidance before I conclude.

Thank you, Ozan. As Ozan mentioned, in Q3 of 2026, we had a strong performance that combined 47% year-over-year revenue growth with a 9% GAAP operating profit margin and an 18% adjusted EBITDA margin. Total revenue in the third quarter of 2026 was $123.0 million compared to $83.5 million in the third quarter of 2025. Both our prenatal and oncology product lines demonstrated strong growth in the quarter. Prenatal revenues consisting of clinical testing revenues and revenues from clinical trial support and other services increased 42% to $105.9 million in Q3. Oncology revenues increased 96% to $17.1 million in Q3 of 2026 versus Q3 of last year. Our total revenue growth was driven primarily by test volume across both prenatal and oncology, as well as continued expansion of our prenatal ASP year over year. TrueUp revenue was $7.6 million in the third quarter of 2026 compared to $2.8 million in the second quarter of 2026 and $3.7 million in the third quarter last year. Excluding TrueUp revenue, total revenue grew 8% sequentially versus the second quarter of 2026. TrueUp revenue rose sequentially, driven primarily by progress in resolving the held claims issue with one payer that we discussed in our second quarter call. Gross profit in the third quarter of 2026 was $87.1 million compared to $58.4 million in the third quarter of 2025, resulting in a gross margin of 70.9% in the third quarter of 2026 versus 69.9% in the third quarter of 2025. The increase in gross margin was primarily attributable to continued increases in our overall ASP. Total operating expenses were $76.1 million in the third quarter of 2026, compared to $48.8 million in the comparable prior year quarter, representing an increase of 56%. Within total operating expenses, R&D expense was $20.2 million in the third quarter of 2026, compared to $13.0 million in the comparable prior year quarter. SG&A expense was $55.9 million in the third quarter of 2026 compared to $35.8 million in the comparable prior year quarter. Operating income was $11.0 million in the third quarter of 2026 compared to operating income of $9.6 million in the third quarter of 2025. Our operating profit margin was 9% compared to the 5% operating margin we delivered in the second quarter of 2026. Net income available to common shareholders was $17.4 million or 32 cents per diluted share in the third quarter of 2026 compared to net income of $1.5 million or 10 cents per diluted share for the same period in 2025. Looking at the cash flow statement for the third quarter, the cash flow from operations in Q3 was $12.5 million while capital expenditures were $3.9 million. This resulted in free cash flow of $8.6 million in the third quarter of 2026. We are well capitalized with a very healthy balance sheet. We ended the third quarter with $562 million in cash and equivalents. We believe our balance sheet positions us for strong growth moving forward. Finally, I will provide an update on our full year guidance for 2026. We are raising our 2026 total revenue outlook to a range of $460 million to $470 million from $450 million to $465 million previously, representing an increase of $7.5 million at the midpoint and growth of approximately 51% to 54% compared to full year 2025. We also expect to operate the business such that it will continue to generate profitability similar to current levels, even with significant continued investments. I will now turn the call back to Osan to conclude.

Thank you, Ross. To close, our mission is unchanged. We are transforming healthcare, one molecule at a time, one patient at a time. What gives me confidence is not any single result, but the way each part of our business builds on the others. Every piece of evidence we publish strengthens the case for our platform. This quarter, a prospective study validated Unity Fetal Risk Screen as a first-line test and our head-to-head data showed NorthStar response delivering on par to superior performance versus a tumor-informed assay. Each launch broadens the reach of our platform and NorthStar Clear will extend it into early stage cancers with MRD next month. And our financial profile continues to set us apart. We grew revenue 47% year-over-year, maintained gross margins at 71%, delivered a 9% gap operating margin and an 18% adjusted EBITDA margin, and raised our outlook for the year. We believe we are truly differentiated in molecular diagnostics with our unique and proprietary technology positioning us for sustainable growth and long-term profitability. Our long-term goal remains the same. To transform molecular diagnostics, build a category-defining company, and earn our place in the S&P 500. We are proud of what we have accomplished through the first three quarters of 2026, and we look forward to sharing our annual results with you on our next call. Thank you.

Over to the operator.

Thank you. As a reminder, to ask a question, please press star 1 1 on your telephone and wait for your name to be announced. To withdraw your question, please press star 1 1 again. One moment for questions. Our first question comes from Subbu Nambi with Guggenheim. You may proceed.

Hi, this is Rikki on for Subbu. Thanks for taking our question. Maybe first, so there were some changes recently in the competitive landscape in prenatal. So does LabCorp owning first gene, which does have fetal recessive testing components, change anything about either your competitive positioning or how you're approaching the market in terms of competition?

Thank you, Riki, for the question. You know, in the past, As you know, previous acquisitions and consolidations have created disruption for customers and have become growth opportunities. We believe that this can be another good opportunity for us for further organic growth. We believe that we you know our unity fetal risk screen is so differentiated with you know so much clinical data backing that you know other tests that are coming to market you know will not have a significant impact in our competitive positioning.

That makes sense and just to follow up then on I guess both Prenatal and Oncology. Have you seen any uplifts from EMR ordering showing up in volumes yet? And if not, when could we start to see that?

We are starting to see some of the earlier integrations showing impact even in accounts that have been using us. So as you know, with EMR, it is sometimes easier to integrate the accounts that might already be using our test in some other form. And in those accounts, what we see is that we get a higher number of tests, even if they were fully converted in previously. But we also are working on new health system adoptions with a number of health systems. And we have seen in the past with Q2 and Q3, Last year, each health system can be a significant additional test volume growth, and that is why we are investing so much in the health system side of things, you know, with Epic Aura and the Unity Fetal Risk Screen expanding to 130 genes.

Thank you.

Thank you. Our next question comes from Mark Massaro with U.S. Bancorp, BTIG. You may proceed.

Hey guys, thank you for taking the questions and congrats on a strong beat and raise quarter. I wanted to start on North Star Clear. I do like the branding of the name of the test. You know, other companies in the space, when they launch an MRD test, that's not reimbursed. We've seen others sort of manage the volume growth in order to limit some of the drag in the bottom line. So I wanted to just ask, maybe can you walk us through your plan? I know it's launching on December 15th, but to what extent do you put this test in the hands of all of your reps? How hard do you push it? And can you maybe give us a path to your reimbursement timelines and any particular indications you want to call out?

Thank you, Mark, for the question and for the kind words. This is actually where we are truly differentiated in. Because of the way that we design assays and because of how QCTs amplify the signal so much more compared to other methodologies, we have designed our MRD tests to have much, much lower cost profile compared to some of the other MRD tests in the market. In fact, we believe that as the test volume increases, it is going to get to the same place as responses today. It will be gross margin positive without even having Medicare coverage. What that means is that we don't have to throttle the test volume the way that other companies have to because of the impact on the bottom line, because we actually don't expect to see an impact on the bottom line even as MRD scales. and that is why we are not going to limit the indication and you know that can result in I think faster test volume growth compared to a more limited launch that you know other companies might be forced to do.

That's fantastic and then I know this is a pan cancer test you know others have typically started with colorectal moving to some of the larger Can you give us a sense for your reimbursement trajectory? I don't know if you can comment on any indications where you plan to submit data. I recognize we're months away from that but how should we think about the cancer types that you might be targeting initially?

We are actually doing studies across all three largest cancer types, as you mentioned, colorectal, lung, breast, as well as their subtypes. But of course, MRD studies take a longer time as well. What we are going to launch with is the head-to-head data around CRC and some clinical data around CRC. But we have been collecting samples for doing clinical studies across multiple cancer types We might start with, you know, initial submissions in CRC as well, but we believe that a tissue-free test has, you know, significant advantages outside of CRC, especially because, you know, in other cancer types, tissue availability is, you know, much lower and the QC fail rates are much higher with, you know, tumor-informed tests.

Excellent. And maybe one last quick one. I know that at the time of your IPO, You talked about how you welcomed head-to-head competitions, and so it's nice to see the North Star response data against another tumor-informed assay. I'm wondering, Oguzhan, if you're planning other head-to-head type studies, whether it's with North Star Select, whether it's with North Star Clear. And I'm just sort of curious about these studies take time, and so I'm just wondering if we can expect any perhaps in 27 or is that more of a later timeline?

As you know, we have already published a peer-reviewed study against all existing competitors at the time for North Star Select where we showed 51 plus percent more actionable therapies. In clinics, we actually continue to do those head-to-heads to show for their own patients for a practice that we can detect significantly more options for patients. And this is one of the big drivers of our growth. We are winning these head-to-heads literally every day in the clinics, in the field for North Star Select. North Star Clear, at the time of launch, as I mentioned, we are actually going to do a head-to-head as well against tumor-informed comparator. This is going to be in CRC initially, but in the future, I think we can certainly look into more head-to-heads for MRD as well. This is one of the One of the areas that I think we are really differentiated from other molecular diagnostics companies, we truly welcome these head-to-heads to be able to show that our tests are superior.

That's great. Thanks so much for the time.

Thank you. Our next question comes from Dan Arias with Stifel. You may proceed.

Hi, guys. Thanks for the questions. Oguzhan, on prenatal volumes, by my math, the volume number was in the neighborhood of 190,000 or so. Is that ballpark correct? And then I think the way that seasonality tends to trend for you guys has 4Q often similar to 3Q. So that would kind of put the prenatal volume gross number in like the mid-20s for the year. If I think about next year, and I know that we'll get the details next quarter on next year, but You know, you have REP productivity, you have unity conform, you have EMR integration progress, and then you have this new 130 gene panel. So again, I know we'll get the guide, you know, at the beginning of 2027, but as a starting point, do you think that volume growth accelerates next year for prenatal?

I think it is a matter of timing with respect to all these health system initiatives that we are doing. Dan, we previously talked a little bit about this, but just as a reminder, prenatal is not a monolithic market. There is the independent clinics, which is about 40% of the market, and then there are health systems, which is about 60% of the market. Our products, our positioning, our continued quarter over quarter growth really focus on these single specialty clinics. And of course, it is much easier to grow from within that 40% from 5% to 10% and then 10% to 20%. And as we get to being the largest market share in independent clinics, It is not surprising that the growth in independent clinics would slow down. And if you look at the health system, though, that remains a really big untapped opportunity of 60% of the overall market. And that is what we had seen in Q2, Q3 last year when we had close to almost 20,000 sequential growth in Q3 last year, which was, I think, the strongest test volume quarter growth that we have potentially ever had. So really, that is when we realized that we need to invest in the health system growth. And that is why we did the Epic Aura integration. We expanded to 130 genes. All of these things were required to be able to continue to win health systems. But health systems are long sales cycles. These are 12, 18, 24-month discussions. So with some of them, we are, I think, getting closer to the finish line. And we can certainly see upside to test volumes for prenatal as they happen. But we also, I think, are going to see oncology contributing a bigger and bigger component of growth next year as well, coming probably closer to, in terms of sequential test volume growth, similar to prenatal levels.

OK. Okay, and then just as a follow-up, Ross, the new revenue number, the range for the year, does that assume some amount for true-ups in 4Q?

No, we, sorry, Dan, we exclude, you know, any true-up revenue from our forward-looking, you know, guidance. You know, so it includes the historical true-up, but we don't include anything for Q4.

Just making sure. Thanks.

Thank you. Our next question comes from Tycho Peterson with Jefferies. He may proceed.

Hey, team. This is Noah on for Tycho. Thanks for taking our questions. I just wanted to start by asking about the new CLFS proposal. Looks like your carrier screening rate will be going up by 112%, also seeing an increase on North Star response, but I think some of the aneuploidy codes are going down next year. So just how are you thinking about the moving pieces there? Thank you for the question.

Of course, it is still not certain if the PAMA changes will be in effect. I think we are in a very fortunate position that we are looking at an overall increase rather than decrease. The only code that we use that is common with other laboratories In general, for a major test is the aneuploidy code. And as you said, you know, that will be decreased. But our increase on the single gene and IPT, I think, you know, will make up for it. And in the long term, it actually puts the potential for single gene and IPT to be a huge ASV driver, to be really high, especially, you know, if The clinical practice changes and single gene and IPT continues to get reimbursed more and more. In terms of the oncology, of course, that would be a really net positive for us if our response is increased almost 30% from a CLFS perspective. But again, it is difficult to comment on the full impact of how that is going to change our response ASPs. before it gets implemented. But it certainly would, if it were to get implemented, I think it would make our response gross margins particularly positive, even without Medicare coverage.

Got it. Thanks. That's helpful. And then it's just one more on the oncology side. With the MRD launch upcoming, how are you thinking about your needs for hiring new sales reps with existing sales force today? You also saw the MRD test, and maybe I just missed it earlier, but is there an updated expectation around mold DX timing for Northstar response?

For the first question, With respect to different Salesforce, we are going to use the same Salesforce. In particular, we believe that the providers who are already using our select and response test, they have already switched from other competitors to us. They believe in the technology. They believe in what we can do. They have seen head-to-head results. So those are going to be, I think, the first customers that we can go to to be able to switch them. but we also believe that MRD is going to open up doors to us in places that access might have been difficult in the past. With respect to the response in Medicare coverage, we believe that, and you might have seen this I think in other timelines with respect to tissue-free tests versus tumor-informed tests, that Moldex seems to have a much, much higher bar for tissue-free tests. And that is why we have done the head-to-head study to show that we are on par to superior to the tumor-informed tests. We believe that that piece of evidence really de-risks the Medicare coverage for response. So that is why we believe that it is a matter of really when rather than if. and while we still believe that it can happen by the year end, the timing is uncertain.

Got it. Thank you. Thank you. Our next question comes from Kyle Mixon with Canaccord Genuity. You may proceed.

Kyle? Thanks for the question.

Hey, hey. Thanks for the question. I was just hoping you could talk a little bit more about the health system penetration and the rollout there in 2027. I know we don't want to really talk too much about the kind of guidance and outlook there, but just like qualitatively, you have a pipeline of systems, you know, how long could that take and what could that really mean in terms of additional tests to come online? Thanks.

So without getting into specific numbers, we have more than 20 health systems that are in various parts of the pipeline. And each health system can be anywhere between 2,000 tests to 5,000 tests per quarter. Of course, not all of these health systems will happen over the course of the next 12 months. But we are very encouraged by the progress that we are seeing in many of them. A lot of the times, this is not even about the clinical cells. In many of these health care systems, the clinical decision team might have already even made the decision that they want to switch to unity. But just the EMR integration, the legal, the phlebotomy, the logistics can take anywhere between six to even more than 12 months. So when we are really thinking about guidance, which we are not providing for 2027 yet. We typically don't incorporate any of these health systems into our guidance, but I think more and more we are going to see an increase in contribution from these health systems in 2027 and 2028.

All right, thanks, Ozan. And then on the prenatal menu, Just kind of like the wars that go on between the competition. I don't think there's an answer yet in the marketplace for the larger gene, the 130 gene panel. I mean, I guess like how far of an advantage does these sorts of like innovation in terms of the menu and the tests kind of provide? Is that kind of the core here or do you think there's like a commercial edge that you're sort of, you know, gaining or growing into, I guess, as you sort of mature as a company?

Certainly, I mean, what we have realized is that to be able to win in these health systems, you need products that are attractive to every single stakeholders. And I think historically, our products with smaller panels have served the needs of OBGYNs and with our fetal antigen tests, you know, MFMs. But, you know, because we didn't have even just standalone carrier panels that were larger Panels, let alone single gene NIPT. I don't think we were serving the full needs of every single stakeholder, for instance, including genetic counselors. And what we realized that every stakeholder is important in a health system, and you need everyone to be enthusiastic for them to go through the trouble of changing. So that is why I think 130 gene is such an important addition. It might not be the test that becomes You know, the majority of the test volume, but it becomes a test that unlocks these discussions in health systems.

Thank you. Our next question comes from Casey Woodring with JP Morgan. You may proceed.

Good afternoon, this is Paul on for Casey. Thanks for taking our questions. Would love to hear more about what kind of data we could expect to see by year end for North Star Clear. Can you share anything about any studies in the pipeline as you look to demonstrate the high sensitivity of the assay? Assuming there will be some pan-cancer studies, but would you also look at running single-indication studies, maybe in indications that are really key, like breast cancer, where there's some more specific subtypes that you'd want to have more granularity, for example, or just any color on kind of a data generation pipeline?

At launch, the clinical data is going to focus on CRC because I think that is where we can show true apples-to-apples comparisons to other tumor-informed assays. But I think in 2027, We are going to certainly have other cancer types and other data readouts that we have already started clinical studies for them.

I appreciate that. And then just as a follow up, your MRD assay has been really well telegraphed since last year. I'm just wondering to what extent Could there be some pent-up demand from existing oncology accounts who've been waiting for your launch? Do you have accounts who are just sort of waiting for December 15th to adopt North Star Clear or is perhaps the investor community maybe more familiar with the fact that this test is coming than the oncologists?

There's certainly and some pent-up demand. We haven't been kind of pre-selling and talking about our MRD as much with the customers, but we actually already see, in some cases, physicians using our response test even outside of the late stage indication that it is designed for. So that really tells me that there is unmet need in our physicians and they are already sometimes using our response test for MRD. So that, I think, is a really strong indication that we are going to have adoption in our existing physicians for our MRD test.

That's helpful. Thank you.

Thank you. Our next question comes from David Westenberg with Piper Sandler. You may proceed.

Hi, guys. Thanks for taking the question. So I'm going to first maybe ask about consolidation and acquisitions in the prenatal space. Does this change how you might think about market shifts opportunities? And one thing about genetic tests that tend to be like a decade old is that you sometimes have a lack of discipline in contracting from some of the players. Do you think that maybe you could see with a more concentrated environment more discipline in contracting and maybe some – and some better ASPs in the future or maybe say less negative pressure on ASPs in the future?

With respect to ASPs, I think we have been so disciplined, Dave, that we have only contracted when the contracts would be additive to us. We don't see a significant change that this would bring to the market. In terms of the You know, test volume shifts. So, you know, as I mentioned this a little bit previously, but as you know, you know, in these acquisitions do not really tie customers to the acquiring party in any way. And previous acquisitions and consolidations have created a lot of disruption for the customers that might be used to, you know, one way or dealing with their customer service, their lab operations, their results, their billing policies. And as those things result in disruptions, they become really important growth opportunities for us and for any other parties that might be in a position to use this. So we believe that this is another good opportunity for organic growth.

Got it. Perfect. And then, you know, Oguzhan, I know you've been very disciplined around margins and profitability, etc. And, you know, it comes out in the P&L, etc. But, you know, on a go-forward basis, you do have this clear product. You have more oncology products coming through. How do you think about investing versus that 70% gross margin versus that EBITDA positivity that you had in If you did decide to spend a little bit more, would that be sales or maybe CapEx? Or do you think maybe even a whole continuum of new products, for instance, in, say, MSAT or something else that would be on the bigger side?

I think in both short-term and long-term, we want to maintain our GAAP profitability. But because of the way that we designed the assays to be cost efficient, I don't think even as we scale our oncology products, we are going to see an impact on our gap profitability. There can certainly be an impact on the overall gross margins as oncology becomes a bigger part of the business. But we believe that we can have both rapid growth and continue to invest in both the growth of the sales force, which drives the test volume growth, as well as the clinical studies. Clinical studies in the long term drive such higher ASPs through coverage. that it is an area where I think it makes sense to continue to invest and invest more in in 2027.

Thank you.

Thank you. Our next question comes from Matt LaRue with William Blair. You may proceed.

Hey, good afternoon, Oguzhan. A lot of territory covered here, but I want to follow up on The head-to-head that you talked about that you published back in October. It's been about a month since that time. Obviously, it sounds compelling. I'm curious for folks who haven't adopted response, you know, was this head-to-head? Has it been compelling enough to have some new providers give you a shot? Or if not, are there other things? that people are looking for in terms of the product offering, workflow, turnaround time, et cetera, that you might need to add to the table.

I think this has been already an impactful clinical study for us to show, in addition to our previous head-to-head with Select, that our platform is You know, strong and superior. And it is, I think, going to continue to drive our response test volume growth. You know, we have seen a very strong response volume in Q3s, and we believe that that is going to continue to continue in Q4 and in 2027.

Okay, great to hear. And then I guess just to put a fine point on the positive, clear commentary throughout the call. It sounds like clear, you know, has the potential to be a meaningful revenue contributor in 27 and not sort of, you know, just being here about evidence generation and building a funnel. Is that right?

I mean, ASPs are, of course, not going to be, you know, thousands of dollars for a test that doesn't have Medicare coverage yet. and we are going to be scaling it. I think the better way to think about this is that we now are launching a tissue-free test that can be truly category-defining. No tissue-free test has historically shown on par performance with tumor-informed tests. and this is the first time that the physicians don't have to choose between convenience versus the sensitivity. And given that in some cancer types, failure rates can be so substantial, I think having an ultra-sensitive tissue pretest is going to be a really big part of our long-term growth. I think for 2027, Thank you. I would like to thank everyone for joining. As I mentioned previously, our goal is to build a category-defining company and this quarter was another great quarter in our 20-mile march towards that. We look forward to sharing our Q4 and our annual results with you on our next call. Thank you.

Thank you. This concludes the conference. Thank you for your participation. You may now disconnect.