Natera (NTRA) Q2 2026 earnings call transcript

Thanks, operator. Good afternoon. Thank you for joining our conference call to discuss the results of our second quarter of 2026. On the line, I'm joined by Steve Chapman, our CEO, Solomon Moskovich, President Clinical Diagnostics, and now it's a lesson general manager of Oncology and our Chief Medical Officer. Today's conference call is being broadcast live via webcast. We will be referring to a slide presentation that has been posted to investor. natura. com, where we play 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-sized partnerships, clinical studies, and 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'll talk to 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 file from time to time with the SEC, including our most recent Form 10K or 10Q and the Form 8K 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, August 6th, and 2026. If this call is replayed or reviewed after today, the information presented during the call may not contain current or accurate information.

If Tara declares 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.

Great. Thanks, Mike. Let's get to the highlights on the next slide. We had an exceptional quarter. We processed approximately one million, 44,000 tests in the second quarter, once again exceeding one million units and setting a new company record with strong volume performance across the business. In oncology, we processed 283,000 clinical MRD units, representing year-over-year growth of approximately 56% compared to Q2 of 2025.

Clinical MRD volumes grew 34,000 units over Q1, which is the largest sequential increase to date. Beyond volume growth, we met several crucial milestones in oncology. Signature became the first MRD test to get US FDA approval as a companion diagnostic and the first MRD test to get Japanese PMDA approval. In addition, the NCCM Guideline Committee issued a Category 1 recommendation for signatory guided adjutant treatment in muscle evasive bladder cancer.

We'll get into all of these topics later on the call. We generated approximately $753 million in revenue in the quarter, which represents approximately 38% growth over Q2 of last year. X revenue, true-ups, or revenues grew approximately 40% year-on-year. Growth margins were strong again at approximately 65%, driven by another quarter of sequential improvement in AFPs. We were also pleased to generate positive cash and flow again this quarter and trim operating losses while continuing to invest in growth initiatives in R&D.

On the guide, we are in a position to completely reset the revenue range, raising it by $100 million at the midpoint. Our new range is $2.85 billion to $2.91 billion in revenues, and we are holding OPEX steady. The guide implies 31% revenue growth this year, X true-ups, and we feel very good about hitting this range. We are clearly on a roll, and I'm excited to review the progress since our call in May.

Okay, let's get into some of the business trends on the next slide. I think the growth of total tests over time is remarkable when you look at the longer-term picture here in the chart. In the quarter, women's health results were particularly strong on a seasonally-adjusted basis with high single-digit growth versus Q2 of last year. Q2 is typically our softest quarter for women's health due to seasonality, but we counteracted that effect this year with particularly strong new account wins driven by fetal-focused adoption and early returns on the launch of our newly-enhanced panoramic test. We think this puts us in a strong position to continue executing in women's health for the rest of the year. We also had another strong organ health quarter as volume continued to ramp, and then, of course, we had our best quarter yet for Signetera.

The next slide shows our clinical oncology units over time. As a reminder, that's primarily Signetera clinical units but also includes a small number of latitude cases. Our sequential growth of 34,000 units was well above our internal expectations with performance fueled by a few drivers. Let's first look at the changing units between Q1 and Q2. You'll recall that on the Q1 call in May, we described weather related events that suppress Q1 of our devolions by several thousand units. We don't think we necessarily recover those units in Q2, but the change quarter over quarter is exaggerated by that artificially lower Q1 number. Mike will expand on this as it relates to the guide later in the call.

In addition, last year, we made a significant investment in the size and the breadth of our commercial team. Most of these folks were hired in the first half of 2025, so we are pleased now to see them hitting their strides. We also achieved some critical milestones for Signetera, including FDA approval, and we've seen an uptick in general Signetera adoption as a result.

We are seeing this in new counts and new patient starts, which were both very strong again this quarter. This broad-based acceleration is happening across tumor types, with colorectal and breaths remaining our largest indications. I am also really encouraged by the contribution from the long tail of indications, both because it demonstrates broad adoption of Signetera and clinical practice, and also because it increases the revenue opportunity as we expand coverage to additional tumor types.

At the end of the quarter, we got the NCCN guideline in muscle invasive bladder cancer, and the PMDA approval in colorectal cancer, both of which we think bodes well in terms of future adoption. So, we feel really good about where we are and the ongoing momentum.

Moving to revenue on the next slide, total revenues grew approximately 38% year over year as continued ASP execution accelerated growth on top of the volume performance. Maintaining this level of top line growth, given the size of our revenue base, is pretty remarkable. We had about 52 million in revenue troughs this quarter, which is trending down in both absolute terms and as a percent of revenue.

X troughs are revenues grew about 40% year on year. We had another good quarter in Women's Health and Oregon Health, ASPs, and we were pleased to see Signetera ASPs increase again. Signetera ASPs were up to roughly 1275, as we continued to drive more consistent reimbursement from Medicare Advantage and commercial plans in biomarker states. We made a significant investment in revenue cycle management a few years ago to get more consistent reimbursement for covered services. While we've completed most of the major initiatives for Women's Health and Oregon Health, we still think Signetera ASPs have the potential to grow substantially over time, both from operational initiatives, as well as potential additional MOLDX coverage decisions and broader guideline inclusion.

We talked in the past that we think a mature Signetera ASP can reach around $2,000 and we still feel good about that as our long-term target. The next slide shows our gross margin progress across two time periods. The left chart shows reported gross margin versus Q2 of 2025, with solid progress mainly driven by ASP improvements over the past year. On the right hand side, we're zooming in on sequential growth X true-ups, where we had a roughly 50 basis point improvement over Q1.

This was due to several factors, including both ASP wins and returning to a more normalized ratio of reported to accession units compared to Q1. Pogs increased slightly in Q2, as we saw up to 10 volumes from some of our recently launched products, particularly for fetal-focused latitude and signetera genome. When we launched these products, we leave a lot of room to achieve Cogs improvements over time as volume scaled, and we're already executing on that roadmap.

Latitude and fetal focus also present ASP upside over time. For example, we have a latitude submission in currently to MOLDX. We think we can keep improving margins slightly in the near term, despite this new product Pogs impact as we did this quarter. Longer term, we feel very comfortable about reaching our target of 70% plus gross margin. The margin improvement going forward is driven mostly by major events, like MOLDX coverages or the completion of key internal Cogs projects. If you look at our progress on gross margin from the mid-40s to the mid-60s, it wasn't strictly linear. We had periods of incremental progress and also step-up function changes, and I think we'll have a similar trajectory in the future.

Okay, with that, let me turn it over to Solomon to discuss some of the exciting clinical and product developments this quarter. Solomon?

Thanks, Steve. I will talk through some of the catalysts that hit in the second quarter, and I want to start in Women's Health with our launch of the Enhanced Panorama because it addresses something that has been a gap in prenatal screening for a long time, achieving reliable test performance at low fetal fractions. During pregnancy, fetal fraction is the proportion of placental DNA circulating in the mother's blood, and when that fraction is low, detecting chromosomal abnormalities becomes significantly more difficult, with one prior study indicating sensitivity as low as 62% for tri-submit 21 using a different technology. Despite this limitation, most other labs who use a counting-based approach will routinely provide results at low fetal fraction without sufficient clinical performance data to back it up.

Historically, Natera would return a no-call in such cases, about 2% of the time. Our new Enhanced Panorama test closes that gap. Powered by our novel, snip-informed, deep-sequencing technology, Panorama is now the only NITT with clinical validation data for common tri-semmies specifically in low fetal fraction patients. It combines the best of both worlds, the power of SNPs for fetal fraction measurements, and triple-led detection, and twin zigosity, and more, along with excellent performance at low fetal fractions, bringing the overall no-call rate down to 0.5% and improvement of roughly 80% compared to our prior version of the test. The perspective of blinded studies supporting this launch included over 3,300 patients, with more than 240 low fetal fraction cases, and we detected 100% of the tri-semmies 21 cases in that cohort.

We launched this in May, and the reception among OBGYNs has been very enthusiastic, resulting in many new account wins. This reflects a set of customers who always wanted to order snip-based testing with Matera, but had held back due to the no-call rates, which is now resolved. We think this sets up nicely for volume growth in the back half of a year.

This new Panorama also rounds out a multi-year run of innovative launches in prenatal health. Last year, we launched fetal focus, our next-gen single gene and IPT to detect inherited conditions like cystic fibrosis, which has continued to exceed our expectations driven by the strength of the expand trial. And the year before, in 2024, we launched our fetal RHD test, addressing a significant unmet need given the nationwide road game shortage that year. Amazingly, the demand for RHD testing has continued to steadily increase, despite the alleviation of that original shortage. Taking together, these three launches reflect the breadth and consistency of our innovation and breast trajectory in women's health.

Moving out of organ health, the final Medicare LCD for organ transplant surveillance was published in July, and it represents a meaningful expansion over the initial CMS proposal. Now, in year one after surgery, Medicare will cover six tests for patients with kidney transplant and 12 tests for patients with heart and lung transplants. Then, in years two and three, Medicare will cover four tests per year across all three categories, which is significantly higher than their original proposal. This improvement reflects strong advocacy from the clinical community. After the draft was originally published by Medicare in July of 2025, major transplant medical societies submitted letters to moldy X and support of expanded frequency. This included supportive comments from the American Society of Transplant Surgeons, the American Society of Transplantation, and the International Society of Heart and Lung Transplantation.

We believe that unified voices helped move the needle on this final policy. We have spent years building the clinical evidence base that made this outcome possible, and the August 30 effective date on the policy means we will start to see the benefit of Medicare reimbursement in the second half of the year. We expect this to drive improvements in Prospera ASP and in Prospera Volumes as physicians update their surveillance protocols to reflect the new policy. Turning now to oncology where we had a great quarter, both in terms of commercial adoption and major milestones. In May, the FDA approved Sigma Terra as a companion diagnostic for patients with muscle invasive bladder cancer. This is not just in a Terra milestone, it's an industry first for the field of MRV testing.

Backed by the Global Phase III and Vigor-01-1 trial, it validates the whole tone or concept treat on MRV at the highest level. Then, in June, the Japanese PMDA approved Sigma Terra for patients with colorectal cancer, supported by the Galaxy study. We expect the commercial launch later this year pending final pricing and reimbursement determination, which is on track. That commercial launch will be supported by society guidelines from JSCO and JSMO. They're already strongly supportive of MRV assessment in the adjuvant setting. Then, in July, Sigma Terra received IVDR certification in the EU, making it the first MRD test for solid tumors to achieve this designation in Europe. Under this certification, Sigma Terra is indicated across more than 22 metrics.

This streamlines future clinical trial launches across the EU, creating a competitive advantage for us with biopharma while also ensuring continuity of access for patients after the expected IVD transition deadline in 2028. This also sets in Terra up nicely to achieve future reimbursement in Europe, a key part of our long-term global vision.

These regulatory wins are the culmination of a long road for Netera in developing our regulatory and quality capabilities, and it's remarkable that these approvals have come in multiple different disease indications at the same time. These are also major proof points for our biopharma partners. We are building on this momentum with our newest submission to the Japanese PMDA for Sigma Terra as a companion diagnostic in bladder cancer. With this submission, we are advancing in lockstep with Chugai, who markets at Isalizumab in Japan. Japan reports approximately 34,000 new cases of bladder cancer per year, of which around 20 to 25 percent will be muscle-invasive. Our submission is supported by data from the Invigor 011 trial, and notably that trial had more than 20 participating clinical sites in Japan.

So the leading urologic oncologists in Japan already have experience with protocol, similar to what we saw with the Galaxy trial in CRC. We think bladder represents a compelling second indication for Sigma Terra in Japan, with strong evidence for serial testing every six weeks, and we expect regulatory approval later this year or early next year.

Finally, we are very pleased to see the NCCN issue its Category 1 recommendation in support of Sigma Terra testing in bladder cancer. Category 1 is NCCN's highest designation, and based on the most compelling randomized evidence. Furthermore, the NCCN specifically calls for CTDNA testing using a personalized tumor-informed multiplex PCR MGS assay, which is language that uniquely describes Sigma Terra. This is now the third NCCN guideline to positively recommend tumor-informed MRD testing, with prior recommendations coming in Merkel cell carcinoma and diffuse large B cell lymphoma, all of which reference Niterra's data.

This guideline update is expected to drive adoption across multiple vectors. As Steve described earlier in the call, it is already resulting in new customer starts and more systematic use among existing customers, those who like to wait for NCCN recommendations prior to adoption into standard clinical use. It's really creating an inflection point in the field, for which Niterra is exceptionally well positioned based on our gold standard clinical evidence, our operational excellence, and our industry-leading analytical performance, especially with the phased variant technology acquired late last year from foresight diagnostics.

The NCCN guideline is also driving new positive coverage policies among commercial payers, far beyond what we could achieve with just the biomarker legislation alone. Some commercial plans already had blanket coverage policies in place for FDA-approved companion diagnostics or NCCN-recommended tests. But most commercial plans are publishing new coverage policies to cover significant Niterra. We expect this to drive meaningful ASP improvement.

Finally, as more clinical evidence is published in support of MRD-guided precision medicine, we expect further progress with Medicare coverage, NCCN guidelines, and commercial payers. With that, I'll hand it over to Alex to discuss our clinical roadmap. Alex?

Thanks Solomon. I want to spend a couple of minutes on the depth of the clinical evidence engine we've built behind Niterra. And why do we think it's such a durable advantage? If you look at slide 13, you can see the shape of that engine. For years, much of the MRD field, our cells included, build its early evidence on retrospective biobank studies. These studies are valuable, they're efficient, and they let you establish prognostic performance across many tumor types quickly. But retrospective data on its own only takes you so far. What actually moves guidelines and unlocks broad reimbursement is prospective evidence. Studies designed up front run in real time, and in many cases, randomizing patients or tying Niterra directly to a treatment decision.

That evidence is a different order of magnitude. It carries far more weight with guideline committees and with payers. It also takes real effort and takes years to generate. We made the decision to invest in that harder path early. We've been signing and initiating prospective studies since 2019, and we've been building this flywheel quietly in the background for more than seven years.

Today, as the chart shows, we've opened more than 70 prospective studies of various forms, spanning our own sponsored trials, pharma partnerships, and academic and cooperative group collaborations. The key point on this slide is what happens next. For most of that period, we were putting studies in, investing ahead of the return. Now, the flywheel is starting to really turn. These studies are beginning to read out. You can see this inflection on the right side of the next few years. Each readout is a potential catalyst for guidelines for reimbursement and ultimately for volume. This is the part of the story that compounds, and it's very hard for anyone starting today to replicate. We are just now entering the harvest phase of an investment we began seven years ago.

I want to discuss in more detail than the terra sponsored portion of our clinical trial portfolio. I'm excited to introduce Signal ER-101, the first interventional prospective study that in terra sponsored and operationally running ourselves end to end. The study is now open, and early reception from investigators has been excellent. Let me frame the clinical question because it's a big one. In early stage, HR-positive hurt to negative breast cancer, the most common form of breast cancer, the vast majority of patients today may be over treated.

When a patient is considered high risk, the standard is to add a CDK-46 inhibitor on top of endocrine therapy. But these are difficult drugs to take. More than 60% of patients experience serious adverse events, and a full course of therapy can carry a US retail cost north of $400,000. And the reality is that many of these patients were likely already cured by standard perioperative therapy alone. Signal ER-101 asks a simple but powerful question. What if we use signal terra to identify patients who actually need that escalation? In the study, patients are surveilled with signal terra after surgery, and treatment is escalated to a CDK-46 inhibitor only when we detect molecular residual disease. MRD negative patients are spared a toxic and expensive therapy they may never have needed.

This is exactly the kind of high value clinical question MRD is uniquely positioned to answer. And the addressable population is large, representing a meaningful share of the more than 200,000 women diagnosed each year in the US with HR positive hurt to negative breast cancer, the majority of them early stage.

I want to be clear about why this matters strategically. Signal ER-101 is the first of a broader interventional portfolio, the signal program, and we have multiple additional interventional studies launching over the next few months covering a significant portion of the largest tumor histologies. These studies are designed to farm a standard. They can be viewed as equivalent to a phase two or a phase three trials with the same implications if they succeed, namely the potential to change practice and help define a new standard of care.

And critically, we've built an infrastructure to run these ourselves efficiently and cost timelines and the economics. It lets us bring rigorous, potentially practice changing studies to questions that matter most to physicians and their patients on our own terms.

Finally, let me update you on the progress in early cancer detection. We continue to be enthusiastic about the data we previously presented. Proceed CRC demonstrated excellent performance, including a 22.5% sensitivity and a 91.5% specificity for advanced ad anomalies, an notoriously difficult target, and a strong signal for the underlying technology. Additionally, case controlled CRC performance showed a sensitivity of 95% and a specificity of 91% with stage one adjusted sensitivity of 91% in screen detected individuals. Our pivotal fine study is now approaching full enrollment. We're on track to complete enrollment in the third quarter of this year, with roughly 24,000 average risk adults enrolled today. Our conversations with the FDA have been productive in our ongoing. We plan to read out the fine cohort in 2027 and will provide additional color on the path from there at that time.

Stepping back, we remain very excited about this opportunity. We believe we're developing a genuinely differentiated product. One that from the very beginning was designed around high sensitivity for advanced ad anomalies, the precursors we most want to catch early.

With that, let me hand it back to Mike to walk through the financials. Mike.

Great. Thanks, Alex. The next page is just a summary of the financials compared to last year. I won't belabor all the points that Steve already covered, but there are a few items I want to highlight. The revenue growth over Q2 of last year is particularly notable because you'll recall that Q2 2025 itself was a strong quarter where we put up 20,000 sequential signature growth units for the first time. Obviously, the 34,000 unit growth number this quarter shows you we've moved yet again into new territory.

You can see positive growth margin trends here, year and year, and organically extrude sequentially versus Q1 despite our rapid cadence of launching new products this year that are not yet optimized for COG as Steve described. I was pleased to see loss per share continue to narrow even as we aggressively double down on the future of the business. After taking upwards last quarter, I was also pleased to see DSOs come down again roughly four days to an average of 57 days this quarter as we continue to do a nice job converting our volumes to cash. On the next slide, I'd like to give more granular detail on our OPEX, particularly in R&D. Given this successful commercial team expansion last year, SG&A is relatively stable in 2026, and obviously that investment is paying off really well this year.

We did have some expenses in the first half on SG&A that are not budgeted to return in the second half. To the extent we exceed the SG&A guide range this year, I expect the majority of the overage would come from non-cash expenses, like stock-based compensation charges related to the business hitting long-term incentive targets and litigation expenses. In R&D, we are remaining very ambitious in our core areas of MRD, organ health, and women's health. You can easily measure our productivity over time just by reviewing the speed and breadth of the new products we've launched and the clinical trials we've read out over the last few years. Given the speed of our revenue and gross margin growth, however, we can afford to make these investments to remain in full position while getting scale on the enterprise.

As you can see on the chart, while R&D in our core area is clearly growing, the gross profit dollars are accelerating over and above this growth. What's unique about our current R&D spend is the scale of the investment we are making in early cancer detection this year, which at the moment doesn't yield any top line or margin benefits at all. You can see that visually as the large change on the chart, which represents the roughly $100 million we are spending this year on development work and defined ECD trial. We think that ECD has enormous future potential once launched, and we expect a growth wave from zero currently to millions of tests per year.

So we expect the scaling benefits to arrive for that fourth area of the business relatively soon. Okay, great. Let's wrap up with the guide for the rest of the year on the next slide. We're going to significantly bump the revenue guide now at $2.85 billion to $2.91 billion, which implies roughly 31% annual growth, extra up and meaningful growth in the second half over the first half of this year. We feel good about hitting this guide range, given the volume and AST trends of the business, obviously with Figa Terra, but also given the better than expected seasonal dip, we experienced the women's health. For Figa Terra volume growth assumptions, keep in mind QQ's sequential volume was exaggerated by several thousand units due to weather negatively impacting us in Q1 as Steve described.

So while we had another very strong month in July, we don't expect to set a new volume record again in Q3. We continue to think the right framework for forecasting Figa Terra growth units is this linear growth model we've described in the past. If you take the average growth in units over the prior four quarters, that solves for randomness around weather and any seasonality or receiving day variances over the past year. Overall, the guide is just driven by volume growth and stable ASPs through the balance of the year. On Figa Terra, we've made a bunch of progress with biomarker state and Medicare advantage coverage. So I think really to drive ASPs meaningfully higher, I think we are going to need to expand multi-x indication coverage, get some benefit from the bladder entity and guideline, and eventually get guidelines in additional indications.

Our approach this entire year has been that those drivers are going to help us in 27, and so we will continue to keep them out of the guide for 2026. The rest of the guide, we're going to hold steady. Growth margins, we bumped 100 basis points last quarter, and what you've seen this quarter is the benefit from ASP improvement in a normalizing test-supported system as a session ratio that was balanced out by step up in volumes in the new products, which as Steve mentioned, we think is a healthy development and step to step to generate returns from cognitive reduction projects next year. We are holding steady on topics. We'll keep the same mindset we have to keep our foot on the gas to invest in future growth.

If additional height return projects come away, we are going to make the investments and update you on the quarterly calls. Finally, we are in good shape to generate cash for the year again, which is a priority for us, even as we are in growth mode. Okay, with that, let's turn it over to the operator for questions. Operator. We will now begin the question and answer session. If you would like to ask a question, please press star 1 to raise your hand. To withdraw your question, press star 1 again.

We ask that you pick up your handset when asking a question to allow for optimum sound quality. If you are muted locally, please remember to unmute your device. Please stand by while we compile the Q&A roster.

Yeah, thanks for the question. Yeah, so I think there's some things that happened this quarter that we think were very beneficial. You know, you look at that FDA approval, you know, certainly there's some halo effect coming off of that that was received very positively after the invigorate out. But, you know, if you take a step back and you look at the preparations that we've made over the last couple of years, and we made big investments in the commercial team, we made big investments in medical affairs, we've been investing in large scale clinical trials and data readouts. So all of those things have put us in a position to now be executing and, you know, performing.

So we're super excited to see the planning that we put in now coming to fruition. But ultimately, we really focus on sort of the four or five core things across all of our businesses. One is like an extreme focus on a technology and sort of being on that cutting edge of technology. The second is backing everything with a very significant amount of peer reviewed evidence, and you can see we've continued to invest in that and continued to extend our lead. And then the third is focused extensively on user experience. We've done a lot of things to, you know, implement new ways to reduce TMP issues on tissue to be able to accept more samples, you know, mobile phobotomy expansion and so forth.

And then the fourth is the team that we have an excellent team of both on the commercial side and the medical affairs side. All of those things have put us in a position to be successful. And as we look forward, obviously this 34,000 quarter over quarter is just a blowout record, I think compared to anything that we've done previously. But, you know, I wouldn't say necessarily we're going to repeat that immediately. But, you know, if you look at, I think our previous record was maybe 25,000 quarter over quarter or something like that. And I think we can outperform that, you know, as we move forward. And, you know, Q3 is off to a very good start.

So, you know, I would expect us to be kind of somewhere right in the middle there. Got it. And then a follow up for you. And maybe this is just going a bit deeper into slide 13. Thanks for providing that. I think it's a very good perspective given the competition questions that we normally receive. Could you maybe dive a little bit deeper into it?

Yeah, Alex, go ahead.

Hey, thanks for the question. So, I think slide 13, this is just kind of the perspective portion of our studies, right? So I think on top of this, we still continue to invest and read out biobank studies as well. So we do expect a large bolus of readouts in the next few years. The way I would kind of think about, especially the perspective readouts, you know, I would say there are definitely a few studies that we're kind of monitoring very closely. I think Vegas, for example, a good study that, you know, we've discussed in the past. But a lot of these studies are also, I would say, important in smaller indications. And because they are prospective, and many of them are now interventional, I think that the readouts do have a significant impact in terms of changing care and possibly changing guidelines and reimbursement.

So we can't, given the number, provide details on every single study, kind of an exact dates for when it will read out. Some of this is variable, some of this we don't control, because some of these are being done with collaborators. But as we kind of get closer and kind of enter 20, 20, we'll try to provide a little bit more guidance about kind of the studies that we think are important and a little bit more information about their timing.

Kind of going back to ER 101 and the broader signal portfolio, I think we'll be announcing additional studies as they come online. We're extremely excited about the pipeline. I think the main point is these studies are designed to a high level. I think we said in the prepared remarks, form a level. And many of them are actually randomized. Signal ER is not randomized, but it's not randomized because we couldn't randomize it, but because we're actually looking for performance, so for the CT and negative arm to do so well that really what we're doing is almost comparing to close to 100%. That's how high of a bar we're setting. And if the study is positive, we do believe that this study will be practiced changing.

And that's the mentality we've taken with every single signal study that we've designed and plan to initiate in the next few months.

Let me just add a little bit too. So basically what we did is we sort of went across every histology that we thought could make a major impact on the business. And we said, let's design a practice changing, potentially guideline enabling study, and then we're going to fund those trials. And that's sort of what we've done. And that's why you see a lot of our investment going into these clinical trials. So signal breasts is the first one that we're announcing, but there's going to be a suite across all different histologies. So stay tuned. And it's a big part of our strategy going forward. That was all right.

Yeah, I think that's right. I mean, we've got, you know, we've got these sales folks that have just come online. We made a big investment in medical affairs. We're seeing a lot of momentum, you know, coming off the trials that have read out, coming off the halo effect of the FDA approval. You know, there's some things like, you know, even in bladder, for example, where, you know, the invigor protocol is sort of moving to kind of in every six week protocol as outlined in the approval, you know, and I think things like that can kind of give us an upside opportunity as well, where people may be, you know, starting to draw more frequently where they've traditionally drawn, say, a quarterlier every six months.

So there's a lot of momentum right now. And, you know, I don't think we'll do 34,000, you know, obviously, I think here we really outperformed even our own internal expectations. But, you know, like I said, our previous record, all-time record had been, I think, 25,000. And, you know, if we can outperform that, I think that would be, you know, that would be a good achievement. And, you know, we think we're in a position to be able to do that and kind of continue to notch up as a year goes on. But very strong momentum. I think we're crossing this sort of tipping point in the field where doctors are really starting to believe in MRV as a core part of their practice.

And I think we're the major beneficiary of that, given the breadth of our presence in the field and the amount of data that we put out, you know, the size of our sales team. So everything's sort of together.

Mike, do you want to you want to take that?

Yeah, no, thanks for the question. I mean, I think that so as we mentioned on the prepare remarks, the guide that we put out presumes just stable ASP1275 for signetara through the balance of the year. I think, you know, if you were looking for like what would be an upside pace beyond the guide, which we normally said is something that is, you know, difficult but achievable, I think it would be something in that decode of another 25 bucks through the balance of the year. And I can talk a little bit about why. I mean, the things that drive immediate term ASP upside are things that we're basically getting paid on already right now. Or if you think about the timing of the cool for Q3, we've got to be receiving reimbursement for that unit effectively right now for us to count it in the Q3 results.

So that tends to be things that are kind of more tactical in nature. These are things like improving Medicare advantages compliance with reimbursing for coverage services, expanding coverage within the biomarker states, things like that. The things that we're mentioning on the call are the longer term drivers, and we'll have a bigger impact on ASP. I feel better about the long term vision for getting to $2,000. Feel better about that now than I really ever have since we launched into Terra six, seven, eight years ago. But I think just if you're looking for a kind of tactical kind of move to the next couple quarters, I mean, I think an upside case would be something like 25 bucks just because these recent wins that we've had to take a little while to get into the revenue recognition.

Yeah, it's a good question. I mean, you know, there's always going to be competition. And, you know, we've seen that. I think if you look at probably, you know, four years now, maybe three plus years, there's been major oncology competitors that have had MRD tests that are approved by multi X on the market. So it's not necessarily a sort of a new dynamic. And you can see we've done really well in the face of competition. I think we're going to continue to do really well because we're doing all the right things. So we're, you know, investing in the technology, you know, when we see an opportunity to round out the portfolio or enhance the portfolio, we're taking those opportunities.

We're doing all the right clinical studies. So I think we're in a really good spot going forward. You know, I would just say there's always going to be competition and, you know, other companies are going to do well. But because it's such a large market, it really doesn't have a significant impact on us. I mean, we're still very early in penetration in the overall market. You know, I would sort of say mid single digits. You know, so we think there's a lot of upside here and we're really in the best position to capture that upside. Now, with that said, we're, you know, very keenly watching what everybody else is doing. And, you know, if we think there's an opportunity for us to, you know, push harder in one particular area or sort of close gaps in a particular area, we're going to be really focused on that.

Yeah, it's a great question. So, you know, as you know, we have, we have many tissue types now that are, or many histologies that are, that are covered by multi-acto, then we have a handful, you know, where we, where we still don't have coverage, but we have submissions. And I think, you know, we, we've sort of reported before that we had seven submissions and, you know, which are at various stages and we're excited about, about the opportunity of getting coverage there. As far as what we're seeing in the field, and we're continuing to grow colorectal and breast, which I think are the two sort of largest, as we said in the remarks, but there's a lot of opportunity beyond that.

And as we turn out new publications, we generate new data. We start to see, you know, uptick in these other histologies as well. And we think we're in a really good position to continue to drive growth across the business, both in DRC and breast, but also across this longer tail of other histologies.

Yeah, it's a great question. I would say, with the growth of the timing, it's only hard to say. But generally, we've been able to sort of work through these submissions very successfully over time. I mean, usually if you have a good, peer-reviewed published paper and you submit to MOLDEX, there's going to be some back and forth. And then, ultimately, you'll end up getting coverage. And so that's what we feel like we're in a good position on these. I don't think that timeline of at some point over the kind of second half of 26 and then kind of into the first half of 27, I think that's a reasonable timeline, which is basically rolling coverages over the next sort of 12 months or something in that range.

And frankly, I think it's good that they're very sort of strict in the way that they are. And I think that's benefited us because we generated so much data and so much quality data. And it really, in some ways, is a competitive moat for others that are now entering the market, where it really takes a long time to generate this level of evidence that you can go to MOLDEX so we think it's an opportunity. On the path to 2000, certainly this would make a major impact on the path to 2000.

But Mike, do you want to comment specifically on sort of what number you think this might give us? Yeah, I mean, I think if you just kind of sum up the indications where we've got submissions in flight or we're planning on submitting some MOLDEX, I'd estimate that's worth something like $150 to the ASP, perhaps 200. So Daniel, I think you're estimating roughly the right range. So obviously, that's a transformational difference when you started 1275 and you add that. Steve mentioned the timing to starting to get these coverages. And I think that's right. I think over the next 12 months, I think you start to get these coverages and I would just reiterate what Steve was just mentioning on the process.

It's hard to forecast with precision, but I mean, I think rolling approvals over the next 12 to 18 months is probably the right way to think about that.

Yeah, I'm not really expecting anything to that question. I'm not really expecting a lump of true ups specifically from biomarker. I mean, the way that you see this happening is you get a biomarker state law and then you interact with tears in that state and it's kind of a linear kind of grinding process that takes quite a bit of time as we've described in the past. So that kind of linear process of getting tears on one by one sometimes it feels like it's a unit by unit that contributes to the drip of continued true ups rather than a then a bolus. I mean, more generally we said this in the prepared remarks. I mean, the ambition is to have the true ups kind of gradually gradually come down and you've seen that happen both in terms of absolute dollars but particularly as a personal revenue.

So that's the plan.

Yeah, it's a good question. You know, we definitely think we're benefiting from share gain here. You know, we had in the last couple of years we've had we've had some big investments sort of behind the scenes and technology development and that led us to beginning of this year and launching the fuel focus product and then more recently launching an enhanced version of Panorama that really closed one of the major gaps that, you know, people had with the product. So I think right now we're in probably the best position we've been in from a competitive standpoint and we really started to see the impact of that, you know, over Q2. You know, typically Q2 can be sort of a softer quarter just because of seasonality and we were really able to overcome that this quarter, I think, with just the interest in the product portfolio and the interest in the enhancements and the sales team is feeling very positive right now in women's health.

Yeah, Mike, you want to say that?

Yeah, sure. Thanks. Thanks for the question. Yeah, I think, you know, I mentioned in the prepared remarks, there were a couple of one-time expenses in Q1 that I wouldn't forecast in the guide to have them repeat in the second half around non-caster cruels of stock-based comp and some litigation expenses. So that makes up the majority, I think, of that delta. I mean, more generally, I think we are getting a lot more efficient. We're deploying AI really across the business at a pretty frenetic pace, and we're just seeing efficiencies all the time. We've given a bunch of examples in the past of where we can deploy that in a large operation like this. So you've got a large lab, you've got a lot of employees, a lot of patients, a lot of volumes, there's lots of opportunities to automate workflows and to move the employees up the value chain as it works.

So we continue to just do a lot of progress there.

Yeah, it's a good question. So Solomon, I'll have you kind of comment on the tilt penetration. I'll comment first on the coverage. So I think as we said on the last call, we're sort of initially looking for that sort of adjuvant coverage. And then I think following on after that, some point, the surveillance coverage. Now we think we'll be in a position to be able to offer surveillance, but we think coverage will probably come sort of shortly after that. There's a lot of opportunity there, just given the number of CRC patients that are diagnosed, and then now also I think bladder as well is going to be a big opportunity. So Solomon, do you want to comment on the penetration?

Sure. Hi, thanks for the question. With the launch in Japan for CRC expected at the end of the year, we think we're poised for penetration or market adoption, I prefer to say that meets or exceeds the rates we saw in the United States when we introduced signetara for colorectal cancer. And that's because of the starting further along, with more significant published data with medical societies having published guidelines and strengthening those guidelines over time, including expected updates this year from multiple different guideline bodies in Japan. And then the reimbursement is really going to be the unlock, because it's not the way the tests are ordered. It's really a requirement for the reimbursement to be in place in order for clinics to order the test.

I'll just add one of the things. We have a really strong partner in Japan, but we're supplementing that distribution partner with direct sales effort, sales effort, and marketing in Japan. So we feel pretty confident we're going to be able to get this out very quickly. We think given the Japanese thought leadership with the galaxy study that there's already a strong understanding and appreciation for the technology. And it's really going to be about user experience making it easy to order, easy to get results. And we look forward to launching.

Yeah, thanks for the question. No, this is really kind of our standard playbook. We launched new products very frequently. You've seen that pace of the new launches in quite intense over the last year. As those products launch, obviously they're not yet optimized for COX as they get to a volume scale. So as they scale, you get some natural efficiencies with workflows in the lab. And then also once you see, you kind of confirm that you do have the demand for the new product and the investment is worth it, then it's relatively straightforward to then deploy resources then to optimize the workflow itself for COX. Those are some of my favorite R&D projects because you can see what the demand is.

You can see what the savings per unit is. And so it's quite easy to calculate returns on investment capital for those projects. And we've generated very high returns on these COX production projects over the last decade. So just given the pace of the new product launches we've had over the past year, we're well set up to have another wave of COX reduction projects that hit over the next 12 to 18 months.

Yeah, thanks for the question. So I'll take the first one on ECD. So we're actually really tracking along at where we thought we would on the FDA labeling study to find study. We think we're going to be done recruiting this quarter, which is sort of what we outlined in the prepared remarks. So that's really on schedule. We're excited about that. We kind of back to that with this readout of proceed that we had early, I think at the JPM conference previously, which we're excited about. So now we're doing the development work. We're getting the assay ready to be in a position to run the fine study after all the samples are collected and then be in a position to submit to the FDA.

So these are all expenses that over time will go away. But I think for now, this is sort of what needs to be done to be in a position to submit to the FDA. We think this is a huge market opportunity and we're in a position to be potentially one of the key players in this space.

So Mike, do you want to comment on the margin? Yeah, no. It's very similar to the topic we're covering with column, which is, yeah, we did have a huge number of new single-terra stars and hairy promising growth and a bunch of these new products where the cogs aren't yet optimized. But as I just mentioned, we've got ample opportunity now that we see the volume coming in to go and tighten down those cogs and optimize those workflows, which we're excited to do. Again, over the next come 12-day, two months.

And I'll just reiterate this point on new patients. I mean, new patients coming in for single-terra is way up. So we're seeing this very significant excitement. And the good thing about that is that sort of usually kind of foreshadows a significant growth in recurrence monitoring and surveillance in the future.