Hello, and thank you for standing by. At this time, I would like to welcome everyone to the CareDx Investor Webinar Call. All lines have been placed on mute to prevent any background noise. After the speaker's remarks, there will be a question and answer session. If you would like to ask a question during this time, simply press star, followed by the number one on your telephone keypad. If you would like to withdraw your question, again, press the star one. I would now like to turn the conference over to Natasha Wagner. You may begin. Hello, and thank you for joining us. I am Natasha Wagner, VP of Corporate Communications at CareDx. Welcome to our Investor Webcast, focused on AlloHeme, advancing AI-enabled relapse monitoring in AML and MDS post-cell therapy, positioning CareDx to lead in precision medicine for cell therapy. I'd like to start today's call by reminding everyone of our safe harbor statement. These slides and the accompanying oral presentation contain forward-looking statements. All statements other than statements of historical fact contained in this presentation, including statements regarding the future business plans and objectives, potential growth opportunities, competitive position, industry environment, and potential market opportunities of CareDx, together with its subsidiaries, CareDx or the company. CareDx's ability to generate revenue and increase the commercial success of its current and future testing services, products, and patient, and digital solutions, and the outcome of or success of CareDx's clinical trial collaborations and registry studies are forward-looking statements. 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Speak only as of the date hereof and are subject to numerous risks and uncertainties, all of which are difficult to predict and many of which are beyond CareDx's control, that could cause actual results to differ materially from those projected, including general economic and market factors and global economic and marketplace uncertainties, among others discussed in CareDx's filings with the Securities and Exchange Commission, the SEC, including but not limited to, the quarterly report on Form 10-Q for the fiscal quarter ended September 30, 2025, filed by CareDx with the SEC on November 4, 2025, and other reports that CareDx has filed with the SEC. In light of these risks, uncertainties, and assumptions, these forward-looking events and circumstances discussed in this presentation are inherently uncertain and may not occur, and actual results could differ materially and adversely from those anticipated or implied in the forward-looking statements. 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Today, we have on the line John Hanna, President and CEO of CareDx, Marica Grskovic, Chief Strategy Officer of CareDx, Dr. Jeffrey Teuteberg, Chief Medical Officer of CareDx, and Dr. Ran Reshef, Professor of Medicine at Columbia University and Director of Translational Research, Blood and Marrow Transplantation Program at Herbert Irving Comprehensive Cancer Center. Now I would like to hand it off to John Hanna. John? Thank you, Natasha. Good morning. I'm John Hanna, President and CEO of CareDx. I'd like to take a moment to remind you, that everything we do here at CareDx is centered around our vision of a world where every patient receives the transplant they need to live longer, fuller lives. And to achieve that vision, we are on a mission as an organization to create life-changing solutions that enable transplant patients to thrive. This mission is what has led to the development of AlloHeme, an innovative solution that extends our long-standing leadership in transplant care. For more than 25 years, CareDx has invested in technology innovations to transform the care of transplant patients globally. Today, we support the transplant ecosystem with end-to-end solutions at scale. We provide IVD kits that enable over 200,000 HLA typing and matching tests annually, helping match deceased donor organs to transplant recipients-... Stem cell donors to recipients. 70% of U.S. transplant centers use at least one CareDx software solution, including organ waitlist management software, quality reporting software, and remote patient monitoring. We fill over 150,000 prescriptions each year for patients managing lifelong immunosuppression therapy, and we have performed more than 1 million molecular assays to monitor for organ rejection for transplant patients. This depth and longitudinal engagement with transplant patients is what differentiates CareDx, and it's the foundation for everything we're building next. CareDx is the market leader in solid organ transplantation. We provide IVD kits, software and patient solutions, and testing services across the full care continuum of solid organ transplant, spanning kidney, liver, heart, lung, and multi-organ transplants. Today, we support more than 200 transplant centers across the U.S., giving us unmatched reach and long-standing clinical relationships. Importantly, solid organ transplantation continues to be a growth market, driven by catalysts such as federal policy to incentivize more transplantation and technological advances, such as machine perfusion. Our long-standing commitment to innovation in solid organ transplantation is what has allowed us to capture over 70% of the serviced market. In October 2024, at our Investor Day, we introduced our development roadmap we called Transplant Plus, which is our path to extending beyond solid organ transplant. Today, we're holding this investor call to further share more about the next exciting frontier for CareDx in our Transplant Plus portfolio, cell therapy. Cell therapy is an ideal indication for CareDx's first Transplant Plus indication. First, these are high severity of disease patients with hematologic malignancies, where our diagnostics can help inform life or death treatment decisions. They are high-cost patients who typically have undergone cancer treatment and cell therapy procedures that have cost the health system over $1 million. The patients are managed by a highly specialized and concentrated group of cell transplant and cell therapy centers, typically at academic medical centers. And fourth, it is a space where we are first to market and can take a leading role in shaping the diagnostic paradigm. When we talk about cell therapy, there are two primary therapies we are focused on for patients with hematologic malignancies. The first, on the left, is allogeneic hematopoietic cell transplants, or HCT. In allogeneic HCT, stem cells come from a donor. Patients first receive chemotherapy to eradicate the cancer, and then donor stem cells are infused to reestablish the bone marrow and immune system function. This approach is typically used in settings where patients are at higher risk of disease relapse and clinicians are aiming for a durable disease response. The second, on the right, is chimeric antigen receptor T-cells, or CAR T-cell therapies. In this setting, the patient's own T-cells are collected and genetically modified to express chimeric antigen receptor, which allows them to bind to and attack cancer cells. The patient is treated with chemotherapy to eliminate diseased cells, then the CAR T is reinfused in the patient. Our Transplant Plus focus in cell therapy is on the patient populations that follow a solid organ transplant-like longitudinal care pathway at highly specialized cell transplant and cell therapy centers. These patients are typically followed closely over time, particularly in the first year, with structured surveillance to assess post-treatment status and identify complications, including cancer relapse. This type of concentrated and specialized market, where patients are monitored longitudinally, is where CareDx has deep experience supporting health systems across the patient journey, coordinating specialized care, and enabling clinically actionable disease monitoring solutions. Since the introduction of the first commercial CAR in 2017, the cell therapy market has grown significantly, with an estimated 20,000 patients undergoing allogeneic HCT and CAR T therapy in 2025. The pie chart on the left shows that when you look at the cell therapy market through the lens of the number of patients diagnosed annually with the type of hematologic malignancy that may be eligible for an allogeneic HCT or CAR T, it is over half of the overall annual incidence of roughly 190,000 heme malignancies today. While not all of these eligible patients are treated with cell therapy today-... The growth in the use of cell therapies is rapidly outpacing the growth in these heme malignancies. For example, AML diagnoses are growing at approximately 2% annually, whereas on the right, we show that allogeneic HCT, typically used in AML, is forecasted to grow at more than four times that rate, at a 9% CAGR from 2024 through 2028. CAR-T use is expanding at an exceptional pace as new innovations continue to press the field ahead and is expected to grow at 30% over the same period. The combination of durable disease incidence growth and rapidly increasing adoption for cell therapy is an important part of why we're focused here, and we're also focused here for a practical reason. These are settings where clinicians need an accurate monitoring solution and where either molecular insight may help inform clinical decision-making, including the potential to identify relapse risks sooner than conventional clinical assessment. By focusing on allogeneic HCT and CAR-T as our initial Transplant Plus solutions, CareDx is poised to be the molecular diagnostics solutions leader in a rapidly advancing field. Within our focused scope in cell therapy, AML remains one of the clearest unmet needs because despite the importance of relapse surveillance, there still is not a universally applicable commercial molecular approach used broadly across patients. That's why our focus centers on AML and MDS in the post-transplant setting, where relapse risk remains a major concern and clinicians are seeking a reliable, longitudinal monitoring solution to guide care. In other hematologic diseases like DLBCL, ALL, and multiple myeloma, molecular tools for relapse detection are already established or emerging, and we're not trying to compete in those MRD approaches. The distinction is simple: clonal proliferation tracking and high-sensitivity variant detection are forms of tumor monitoring. They detect and track tumor-derived signals. What we've built is innovative in that we're measuring something different. Our Transplant Plus solutions are aimed at cell therapy treatment monitoring in a tumor-naive way that are universally applicable to all patients. So we view our solutions as complementary, not competitive. Tumor monitoring answers one set of questions, and what we're developing is intended to help answer a different set of questions that matter in longitudinal post-cell therapy care and therapy management. Bottom line, we're addressing a clear gap in AML and MDS relapse surveillance, post-transplant, and entering areas that are not served today by other players. Our focus on cell therapy enabled us to service a targeted market of approximately 200 bone marrow transplant centers that perform HCT and CAR-T infusions in the U.S. For the rest of our discussion today, we are going to focus on AlloHeme, our novel monitoring solution designed for cancer relapse prediction following allogeneic HCT in AML and MDS patients. Cancer relapse after allogeneic HCT is the number one cause of patient mortality, and monitoring needs to be improved in order to allow clinicians to monitor more frequently and act rapidly to treat these patients that have relapse. That's why AlloHeme is built around a peripheral blood sample. From that blood sample, we use next-generation sequencing to measure micro changes in cell populations over time. We're looking at how the cellular populations change longitudinally in a way that can signal increasing relapse risk. Those measurements are then analyzed through a proprietary AI-derived algorithm that incorporates longitudinal data from whole blood and cell lineages to help predict relapse. The output is intentionally straightforward and clinically usable, a positive or negative result, similar to commonly used MRD solutions. That's what makes AlloHeme distinct: blood-based, longitudinal, and designed specifically for the post-allogeneic HCT monitoring reality in AML and MDS patients. Now, I would like to turn the call over to Dr. Jeff Teuteberg, our Chief Medical Officer at CareDx. Jeff? Thank you, John. So today I'm going to briefly walk you through the AML and MDS patient journey, and I will then re-review the role of relapse surveillance. After diagnosis and risk assessment, most patients start treatment with induction therapy. Induction is the initial phase of chemotherapy intended to reduce disease burden and, when possible, achieve remission. The next step is often consolidation therapy. Consolidation is additional chemotherapy or other therapeutics given after induction to reduce risk of relapse by addressing residual disease that may not be detectable through routine clinical assessment. However, if a patient is considered at high risk for recurrence, they may be considered for an allogeneic stem cell transplant. This procedure is performed in specialized transplant programs operating under rigorous quality and safety standards, and where they are monitored closely for recurrence, which I'll detail in the next slide. The cadence for relapse monitoring is intensive, and it's driven by a simple reality: relapse is the primary clinical concern in this population and the leading cause of post-transplant mortality. In his latest report, the Center for International Blood and Marrow Transplant Research found a two-year post-transplant relapse rate of 30%-35% in AML and 35%-45% in MDS. In the early months after transplant, follow-up is frequent and structured. This surveillance consists of regular clinic visits paired with routine blood testing. Physicians are monitoring for multiple issues at once: engraftment and recovery, graft-versus-host disease, infectious complications, and, most importantly, signs of relapse. Even beyond the first year post-transplant, relapse surveillance continues. Importantly, despite frequent clinic visits and blood work, the most informative assessments for relapse, a bone marrow biopsy, is performed much less often because it is invasive, uncomfortable, and logistically burdensome. Thus, in practice, a physician may only perform a couple of bone marrow biopsies in the first year, the timing of which varies by center and by patient. Hence, there is a critical gap in post-transplant surveillance. The assessments performed most frequently, clinical visits and routine blood work, are not sensitive to early relapse, and the most sensitive test, a bone marrow biopsy, is performed infrequently. Even though these patients are monitored intensively, there's a clear unmet need for molecular surveillance that is non-invasive, easy to obtain and to incorporate into real-world follow-up, and provides earlier insight into relapse risk. Importantly, surveillance doesn't stop at one year and doesn't always occur at the transplanting center. Thus, surveillance often needs to be extended to shared care sites. Despite the advances in allogeneic transplantation, relapse remains the leading cause of death, accounting for nearly 50% of the mortality beyond 100 days post-transplant. The ideal surveillance for relapse would need to meet three criteria: It needs to be sensitive, non-invasive, and universal. Let's start with sensitivity. Existing tools for relapse monitoring after allogeneic transplant have meaningful constraints. Chimerism testing, for example, short tandem repeat PCR, is widely used and can be valuable for certain purposes, but it is not designed for sensitive relapse detection. MRD approaches searching for cancer variants with multiparameter flow cytometry can be powerful, but in practice, is often limited by sensitivity due to the tumor heterogeneity of AML and MDS. In contrast, AlloHeme is highly sensitive for the detection of relapse. Next, MRD testing often requires a bone marrow biopsy to reach the level of sensitivity required for detection of relapse. However, AlloHeme provides a non-invasive alternative via a simple blood draw. Finally, MRD approaches can be highly effective, but only when a predefined target, such as a specific mutation, is known. Without that target, the test simply can't be used to monitor for relapse in a patient. That's why when we say universal, we mean non-bespoke, an approach that can be applied broadly across patients without requiring a specific mutation or tumor signature to be identified upfront. With AlloHeme, knowledge of pre-identified mutations or tumor-specific markers are not needed. Thus, AlloHeme meets all three of these criteria. It is sensitive, non-invasive, and universal. While existing tools clearly have a role, we strongly believe there is a need for a highly sensitive, non-invasive, and universally applicable surveillance test that can be broadly applied across post-transplant patients, and that is what AlloHeme is designed to provide. I would now like to introduce Dr. Ran Reshef, Professor of Medicine and Director of Translational Research for the Blood and Marrow Transplantation Program at the Herbert Irving Comprehensive Cancer Center at Columbia University. Dr. Reshef is a co-PI on the ACROBAT Trial and presented the findings of the study this past week at the 2026 Tandem Meetings of the American Society for Transplantation and Cellular Therapy and the Center for International Blood and Marrow Transplant Research. Thank you, Dr. Reshef. Thanks, Jeff. Thanks for the introduction, and thanks for having me here today. It's, it gives me great pride to share some of the results that I presented this past weekend at the Tandem Meetings, which is the annual meeting of the American Society for Transplantation and Cellular Therapy, in combination with the Center for International Blood and Marrow Transplant Research. So it is the primary international conference for the transplant community. So, we have presented some results from the ACROBAT study in the past, but those were interim and preliminary results. And at this point, I presented the two-year analysis of the AlloHeme test, which, as Jeff alluded to, is a peripheral blood-based test that enables robust relapse surveillance after hematopoietic stem cell transplantation. I presented these data on behalf of the 11 centers that participate in this study, and there was a high degree of interest. I think the room was packed, and it was certainly one of the more populated sessions in the conference this past weekend. Just to reiterate a little bit and maybe expand on what Jeff had already mentioned, we do allogeneic transplants with a curative intent in a broad range of hematologic malignancies, and in fact, even in several types of non-malignant conditions, including sickle cell disease, thalassemia, congenital immunodeficiencies, and a variety of other diseases. It is a procedure that's done with a curative intent, so there's no good substitute for it. For most patients with acute leukemia or MDS, which are the two primary indications for this procedure... Other approaches are not considered curative. Even with all of the overwhelming number of targeted therapies and immunotherapies that have emerged, we don't have very good curative options within those newly approved and novel therapies. So allogeneic transplant remains to be the primary tool if we want to achieve cures. This also explains the growth trends that Jeff had shown with more than 10,000 allogeneic transplants performed in the U.S. annually, which translates into approximately 60,000 allogeneic transplants worldwide. So it is very commonly used and continues to grow over time. Survival after allogeneic transplant remains limited. So, the most recent numbers that I'm familiar with show that it's about a 62% five-year overall survival rate after an allogeneic transplant, if you look across all patients and all diseases. Which means that nearly more than a third of the patients ultimately die after transplant. And when you look at the primary causes of death, you can see this in the left side of the screen here. Nearly 50% of the deaths after the first 100 days post-transplant are from disease relapse. We have made tremendous progress in this field in controlling some of the other complications, such as graft versus host disease, where we have much better therapies and prophylactic strategies than we had in the past. We've made tremendous progress in controlling infectious complications. We have very good monitoring assays to detect very, very low levels of viral reactivations. We have better prophylactic medications for viruses and bacteria nowadays. So we've limited a lot of the morbidity and mortality from non-relapse complications, but have not moved the needle significantly in everything that has to do with relapse of the primary disease. Most of the maintenance studies after transplant have not been successful. Some of the interventions are very aggressive, such as donor lymphocyte infusions and potentially use of CAR T cells, which is largely experimental still in the post-transplant setting. So we need better surveillance methods, and we've had surveillance methods to detect early relapse for many, many years, but those have primarily focused on an assay that Jeff mentioned, which is the short tandem repeat PCR. Which is a way to measure the percentage of donor versus recipient cells in a sample, whether that's a bone marrow sample or a peripheral blood sample. It is a method that's kind of borrowed from identity testing, from police work, from, you know, law and order types of scenarios where you need to identify small amounts of DNA. So it's basically the same type of assay, but it has very limited sensitivity. It is accessible, although it is more sensitive in bone marrow, so it does require bone marrow biopsies to be done frequently in these patients. And again, the level of sensitivity is really insufficient, and, you know, this table says 1%-5%. I think 1% is really a very, a very conservative way to describe the sensitivity. It is often much lower than one percent, or much higher than 1%. So, and additional methods to do early surveillance for relapse look at specific disease parameters. So when we look at flow cytometry in diseases like AML and MDS, it is extremely limited because each patient has a slightly different phenotype. It is a highly operator-dependent, disease-specific and patient-specific assay that has not been standardized for AML or MDS. There is some level of standardization in ALL that's now considered appropriate for use in clinical trials even, and as an FDA endpoint, but for the majority of patients undergoing transplant, this is not a useful assay. When we look at other assays such as qPCR or next-generation sequencing, you usually need to know the patient's underlying mutation panel, and these assays are much more sensitive in the bone marrow and still have some limitations of sensitivity and are very difficult to standardize. So these are mostly assays that have been developed per institution and are applied specifically to very small patient populations and have not been standardized across the board. So we certainly need a better assay, and this is what AlloHeme basically is. So AlloHeme is next-generation sequencing based, and it uses a large array of single nucleotide polymorphisms, several hundreds of them across all somatic chromosomes. So it does not require any prior knowledge of the tumor characteristics, and it, in fact, can even be used in non-malignant diseases because it is simply a better and more accurate measurement of the proportion of cells coming from the, from the donor versus the recipient in a sample. And what you can see here is the study that we designed together with CareDx in order to study this new assay, which is called AlloHeme. This is a prospective observational study that was conducted in 11 centers and has enrolled 285 patients across 11 sites between 2021 and 2023. With, really the design, targeted to develop the AI-based algorithm to come up with a, a final version of the assay and then assess its performance by monitoring these patients over time and seeing whether we're able to detect relapse prior to that actually happening and showing any clinical signs, symptoms, or other lab abnormalities. You can see that, at this point, we have all patients in the study completing 2 years of follow-up, which makes it a very mature and robust data set. The trial enrolled patients with AML, MDS, and ALL, as you can see, and the testing schedule that was built into the study shows that it's biweekly in the first three months, then monthly in the next three months, and then quarterly testing from month nine to month 24. At that point, many patients after allogeneic transplant are already doing well and not coming to their transplant center frequently, so this study tailored the testing schedule to that situation. Here you can see the patient disposition. So ultimately, out of 227 subjects enrolled in AML and MDS cohort, which was, is what I presented at the conference, we ended up with 198 subjects in the analytical cohort. So a number of patients were excluded from this presentation, and that's first of all, the ALL cohort, given that ultimately the enrollment on that cohort was relatively small, and the number of events, meaning the number of relapses that occurred on that cohort, was also fairly small. ALL is a disease where I would have to say we probably use a little bit less transplant today than we used to, as opposed to AML and MDS, where the use of transplant has been dramatically growing simply because we've been transplanting older and sicker individuals with the current transplant techniques. You can also see that several patients were excluded simply because of early events or early withdrawals, or a couple of patients with some issues of study protocol compliance, simply not having sufficient number of sequential tests to analyze. In these 198 patients, you could see that we've observed 40 relapses, and 118 patients completed two years of follow-up, and we've had, unfortunately, of course, as we're used to in the field of transplant, several patients who died from non-relapse mortality. The primary analysis that we've done here is what's called a landmark analysis, meaning that at the two-month milestone, three-month milestone, and six-month milestone, we assess the predictive power of the test. And as you can see here in the red curves, patients who tested AlloHeme positive at or before each one of these time points had a dramatically higher risk of relapse compared to those who tested negative. These are the type of hazard ratios that you would like to see in a highly predictive assay, running between 5.9 and even 11.9 when you get to the six months milestone, meaning that the predictive power of a positive test is extremely good, and it's an excellent marker of impending relapse. That translated also into a maybe more important parameter for the transplanters, which is relapse-free survival, so we include survival here as part of a composite endpoint, and you can see that the performance of the assay is excellent, when looking at this outcome as well, with hazard ratios between 4.1 and 6.2, depending on the specific landmark, and with very high degree of statistical significance. So this is a diagnostic assay, so the main purpose of the study was to evaluate its assay performance, which is the most important thing for future users. And when we look at this overall assay performance over a two-year period, you can see that the area under the ROC curve is 0.89, with a sensitivity of 85% and specificity of 92%, which is truly exquisite for this type of for this type of assay, and especially that we're looking at the peripheral blood assay. So we're sparing these patients the need to undergo sequential bone marrow biopsies by getting this level of sensitivity and specificity simply from a blood test. And most critically, for a monitoring tool, the negative predictive value that you can see here is 95%. So it gives us and the patients a very high confidence that a negative test truly reflects a deep remission with a very low chance of relapse. You can see that we have a few false negatives and a few false positives, six false negatives and nine false positives, specifically. We took a deeper dive into those to see what was the true potential cause for false negativity or false positivity, and that was a very interesting dissection of the data. Among the six false negatives, we found that four cases simply missed the last AlloHeme test before relapse. So the issue was more protocol compliance with sending the blood test in. For a variety of reasons, these things are sometimes missed, and as you can see here, it's also listed in the bullets, we didn't have perfect compliance with the testing schedule. We used a median of 11 tests per patient versus the recommended 14 tests in the protocol. Meaning that just by better compliance and adherence to the testing schedule, you might be able to eliminate some of the false negative tests. Even more interestingly, the false positive, the nine false positives, showed three patients who actually received some sort of therapy to mitigate the risk for relapse without knowing that there is a positive AlloHeme test because the results were not reported to the centers. But there was some other reason for investigators at these institutions taking care of these patients to do something like donor lymphocyte infusion or starting maintenance therapy, perhaps because of a perception that patients had high-risk disease. So, these are not true, these are not really false positives because something was done to these patients to potentially mitigate the risk of relapse and bring it, and bring it down. In addition to that, we did find, one patient who had a relapse beyond the 24-month milestone. So that was not captured by the study as a relapse, but it's certainly not a false positive. It is a true positive. So some of the false negatives and false positives were truly a result of certain elements of study design, using a 24-month cutoff, whereas in the real world, we're looking for, you know, a longer chance of relapse, potentially in some of these patients. And, and of course, some degree of protocol compliance and compliance with a study, blood sampling schedule. What's very important is, of course, a lead time. It's not useful to have a test that is detecting relapse at the same time that relapse occurs. But as you can see here in the swimmer's plot, we have a median of 41 days before clinical relapse when AlloHeme gives us a positive signal. And that's a sufficient time in order to use an intervention, either start some sort of therapy, which can be a hypomethylating agent, it could be a donor lymphocyte infusion, it could be early withdrawal of immune suppression. We have multiple types of strategies that can address a low level of relapse, and we simply, with current strategies, miss that opportunity because we don't have tests that are sensitive enough. And you can also see that in some patients, most likely in the MDS patients, which, when relapses may not relapse in such a fluid and aggressive way, we sometimes get several months and up to one year ahead of relapse, kind of a heads-up that gives us sufficient time to do something about it. Some tables with numbers that I'm not going to go through in very high level of detail, but we've looked, this was a large enough study to look across subgroups, and you can see that whether it's AML or MDS, whether the donor was related or unrelated, whether it was a someone with positive MRD prior to transplant or not, and various other transplant variables, the area under the curve and the levels of sensitivity and specificity are very similar across the board. This can be used as a universal test, agnostic to other various transplant variables. Then we went ahead to do a very important comparison of how does this compare with what we currently do in the real world. And for this, the team at CareDx actually went back to the centers and got them to report what is their real-world use of chimerism assays, which would be the current standard of care prior to implementing an AlloHeme test. And as you can see here, the real-world assays get a sensitivity of about 60%, as opposed to the 85% sensitivity of AlloHeme, and the median lead time is actually zero, which means that most patients actually have their first positive assay by the current standard of care at the same time that they already have clinical clear evidence of relapse. So basically, no, no ability to predict this ahead of time. Since the real-world chimerism is done in various institutions by different methods, some people use the STR PCR like we do at Columbia, but some institutions have developed other assays. So this was a pretty heterogeneous mix of testing. We also tried to do a more consistent modeling of what would this look like if we, let's say, use an STR PCR that has a 1% cutoff, just using the AlloHeme test, but instead of using its, its actual sensitivity, which is 0.02%, just modeling it at a 1% cutoff. And you can see here again that the sensitivity goes down to 53%, so it is very similar or even worse than what the real-world data shows us for the current standard of care. In addition to that, we also realized that in the real world, people don't just use chimerism tests. People use bone marrow biopsies to look at flow cytometry and use a variety of molecular testing, which I've alluded to their limitations earlier. They're mostly patient-specific and non-standardized and institution-specific. And you can see that with all of these tests, as reported by the sites, we have a very low sensitivity, and that's pretty typical for what we actually see in the real world. Like, we kinda know that these tests are not very sensitive ahead of the actual relapse. They're, most of the time, positive simply when it's already clear that the patient has an active, relapse disease. One more thing to mention is that, these tests, primarily rely or almost exclusively rely on bone marrow aspirates, which we can't really do on a weekly basis or every other week. It's a very, very high burden for patients, and, I think the next example kinda shows, how we could certainly spare patients frequent bone marrow biopsies. So this is just one case study from the ACROBAT trial. A 77-year-old female with high-risk AML. At that age, almost any AML is considered adverse risk, with very high-risk characteristics, including, mutations in TP53, multiple monosomies, and abnormal 17p, which is another TP53 locus. And, when this patient came into transplant, she was in complete remission but was already known to be, to have minimal detectable disease.... She had a transplant from a male matched unrelated donor with a non-myeloablative conditioning regimen, which is the only regimen we can use at this age group. She had a GVHD prophylaxis that is building on post-transplant cyclophosphamide, which has become the standard, the most standard GVHD prophylaxis regimen nowadays. You can see here, if we go from left to right over time, the transplant is considered day zero, and usually we do the first assessment of minimal disease or in any one of those assays around day 30. In this case, it was day 32, and we usually do a bone marrow biopsy, so it's a fairly aggressive and invasive procedure for a patient who just spent most likely a full month in the hospital to get a transplant. You can see that this patient was negative by the standard STR PCR, the standard chimerism assay, and also by flow cytometry, was initially also negative by AlloHeme at day 43, but then AlloHeme became positive on day 54. At the same time, peripheral blood testing on this patient was negative, and since we don't do bone marrow biopsies too frequently, this patient only had her next bone marrow biopsy around day 99, and at that point, the relapse was already obvious. She had 8% blasts on immunohistochemistry, and very interestingly, the standard chimerism by STR PCR was unable to detect this relapse, even when it was clearly positive by morphology and immunohistochemistry, whereas the AlloHeme test gave this patient a 45 days lead time prior to this active relapse. This is really just a randomly picked example. We have multiple other examples on the ACROBAT study on how we were able to detect relapse earlier if we had the AlloHeme test available. So just to conclude, AlloHeme is a blood-based robust tool for early relapse detection. We now have two-year follow-up of this ACROBAT study, where we have very high accuracy, an area under the curve of 89% and a 95% negative predictive value. Gives us a median lead time of 41 days before clinical relapse, and it clearly outperforms any of the other MRD methods that are currently used as a standard of care. It is a simple and effective strategy to identify high-risk patients. I would even have to say that the turnaround time that CareDx is designing to launch is going to be much shorter since the current tests done at institutions, for example, STR PCR at Columbia, takes more than a week. Since economically, you have to batch these samples, and when you do them centrally in a lab like CareDx, we will be expecting a turnaround time of about three days. So, I'm very happy that I was able to share these results with you here today on this call, and I will turn this back over to Jeff. Thank you, Dr. Reshef, for your time this morning and walking us through the results of the ACROBAT trial and sharing your perspectives on the data. I'm going to turn back now to the importance of AlloHeme for CareDx, and I want to reiterate that allogeneic HCT is a growing market, and it's growing for several structural reasons. The underlying AML and MDS patient population is increasing, driven in part by demographic trends, such as an aging population. At the same time, we're seeing more guideline-driven referrals as molecular risk stratification becomes more routine in clinical decision-making and helps identify patients who may benefit from allogeneic transplantation, similar to the case study that Dr. Reshef walked us through. Donor availability has also broadened over time, including greater use of options such as haploidentical and matched unrelated donors, and HCT transplant protocols have continued to evolve to support older and more medically complex patients. Overall, outcomes have improved with advances in graft versus host disease management and supportive care for infections and other complications, which has helped reduce non-relapse mortality and improve survivorship in allogeneic HCT patients. Based on this growth trajectory, we estimate the TAM for AlloHeme to be approximately $1 billion. When we model the eligible population, we apply HCT eligibility assumptions, approximately 70% for AML patients and 45% for MDS, based on guideline-informed recommendations and external references. Those assumptions are intended to represent a framework for sizing purposes and is what we show here on the chart for 2030 incidences across AML and MDS and the applied HCT eligibility. Now, real-world HCT use varies meaningfully based on patient factors, clinical practice patterns, and center-specific dynamics. So this TAM size is the opportunity, not a statement about current clinical practice. Our testing cadence assumptions are grounded in the ACROBAT study design, and our pricing assumptions are informed by analogous testing models in related transplant and molecular monitoring settings. The key takeaway is this: as the allogeneic HCT market expands and post-transplant survivorship increases, the monitored population grows with it, driving a rising need for a sensitive and non-invasive post-transplant monitoring tool, and that expanding need is exactly what supports our investment in AlloHeme and the broader Transplant Plus opportunity. As we look ahead, we're excited to be entering a very attractive market, and today, I want to outline our path to commercialization and revenue contribution for AlloHeme as a part of our broader portfolio. In 2026, our focus is on laying the critical foundation for launch. That begins with publication of the ACROBAT study, which we view as an essential step before entering the market. In parallel, we will complete our CLIA readiness activities, including analytical verification of the assay, so that it can be run within our CLIA-certified laboratory. Together, those steps position us for an early 2027 commercial launch, alongside submission for Medicare and private payer coverage. Looking further ahead, we anticipate and estimate that coverage decisions will begin in 2028. As that milestone is reached, we expect to see AlloHeme begin to contribute to revenue growth while we continue to drive adoption and build additional clinical and real-world evidence over time. Importantly, our plan is to serve the cell therapy and allogeneic HCT market in much the same way we've successfully served the solid organ transplant market, through a set of integrated solutions and wraparound services. That includes HLA typing of donor cells and recipients, software tools, and patient solutions such as our pharmacy and molecular relapse monitoring, all designed to fit naturally into cell therapy transplant center workflows. This is not a newly serviced market for CareDx. We already support cell therapy patients today through our lab products business with HLA typing. Our MedActionPlan discharge planning software is broadly used in the cell therapy market today. We have other platforms such as Ottr Cellular, our EMR solution for bone marrow centers, that has already been adopted in several centers across the U.S. What this creates is a familiar model for transplant centers, a coordinated set of services that support adoption, streamlined care delivery, and enhance both provider and patient experience as CareDx begins to service the cell therapy market. I want to thank you all very much for attending today's webcast on our AlloHeme assay and our Transplant Plus portfolio more broadly. I would now like to ask the operator to open up the line for questions. Operator? Thank you. As a reminder, to ask a question, you will need to press star, then the number one on your telephone keypad. And if you would like to withdraw your question, press star one again. We do request for today's session that you please limit to one question only and queue for any additional questions. Thank you. Your first question comes from the line of Andrew Brackmann with William Blair. Your line is open. Hi, guys. Good morning. Thanks for taking the questions. This was a really, really informative session here. So, as we sort of think about AlloHeme fitting in, into the current tool belt of tests that are used here, forgive me if I'm wrong, but it seems that there's really not one standardized tool here for monitoring patients. So is the goal for AlloHeme over time to be that standardized tool? And if so, what more data is going to be needed to drive that conversion in your view? Is that clinical utility or outcome studies? And just sort of how do we think about the investments that you're putting in there? Thank you. Yeah. Thanks, thanks so much for the question, Andrew. And yes, I think you're, you're spot on there. As Dr. Reshef presented, there is a great deal of variability in the tools that are used today to monitor for relapse detection post-allogeneic HCT. And so our vision is a centralized lab services product out of our CLIA lab that can provide that standardization in monitoring for relapse. And then I think to your, your question around what drives, you know, full adoption in the marketplace, it's certainly clinical utility evidence. So today, we presented clinical validation data, where clinicians were blinded to the AlloHeme test results. As we introduce this product into the market, I anticipate that clinician researchers, both in single centers and in multicenter studies, will publish on their experience of using AlloHeme to detect relapse earlier and then intervene on that relapse and the change or improvement in health outcomes that it delivers. Okay, I'll stick to one. Thank you. Thank you. Next question comes from the line of Bill Bonello with Craig- Hallum. Your line is open. Hey, guys. Thanks. I guess sort of a take on what... Where Andrew was going, but with a little more specificity. So is the thinking here that if AlloHeme is being used, bone marrow testing will not be needed at all, or should we think of this as more complementary to bone marrow or, you know, sort of physician choice? And then I guess the, you know, the other piece of that is, was there any— you showed real-world experience on bone marrow. Did the patients in this study also get bone marrow testing, you know, via NGS? And how did the accuracy of AlloHeme compare to the bone marrow? ... Yeah, thanks for the question, Bill. Dr. Reshef, if you're comfortable answering that, I'd gladly defer to you. Yeah, absolutely. So, I do think that this, this level of performance of the assay is ready for clinical use and replacing, current, strategies. So, also, to respond to Andrew's previous question a little bit, most institutions still use STR PCR. The other ones are more kind of specific, institutionally driven, and mostly rely on specific tumor mutations, which are very difficult to, to assess in a standardized, manner or apply broadly. So the STR PCR current chimerism assay are very poor. We do know that they correlate with relapse. I've published about this, more than, 12 or 13 years ago. There are multiple publications, but they don't have this level of sensitivity or specificity, and they don't give you proper lead time. They have a huge amount of, false negativities and false positivities. I think that the assay already is showing adequate sensitivity and specificity to predict relapse. To launch a test and make it clinically useful, you don't necessarily need to create an intervention that would reverse the fate of these patients. That's, that would be the next step, and that will need to be studied prospectively and ideally, either by sponsored trials from companies developing specific medications for this setting or by academic institutions who will examine what, how their own strategies perform. The approach to relapse can be therapeutic if a patient has already relapsed, that, fails 90% of the time. It can be prophylactic, without knowing if the patient is going to relapse, which places the patient at risk, and it can be preemptive, and that's really the novel thing about using AlloHeme. We don't have currently an assay that would allow us to examine preemptive strategies by risk stratifying patients to who is at the highest risk of relapse, and I think this is kind of the perfect niche for this assay. Next question comes from the line of Brandon Couillard with Wells Fargo. Your line is open. Hey, thanks. Good afternoon. What's the optimal sort of testing frequency here? Should we interpret the ACROBAT study as establishing some type of protocol? I think the trial was supposed to be standardized on 14 tests, maybe in one year, and on average, maybe patients actually got 11. Just help us kind of understand where you see that shaking out and what's contemplated in that billion-dollar TAM number, and then how should we expect the reimbursement process to go with it, crosswalk to existing solid organ test? What's the comparable there? Thanks. Thanks, Andrew. I appreciate the question. Yes, we believe that the 14 test protocol is the appropriate protocol for use of the product, given the rate of relapse and the standard of care in terms of how these patients are monitored in clinic. And as Dr. Reshef shared, you know, there's a perception among the PIs of the study that had all sites followed that protocol with 14 tests instead of the average of 11, that the performance characteristics may have improved for the assay. So, when we estimate the TAM size, we did include the 14 time points. From a coverage and pricing perspective, I think this product follows, you know, all other similar products. There's an established coverage process for technology assessment in the Medicare population and as well with private payers that we'll submit through, and ultimately, when this assay is on market, we will apply and obtain a code for it and go through the standard pricing process for the code. Thank you. Next question comes from the line of Tom DeBourcy with Nephron Research. Your line is open. Yes, hi. Thanks for taking the question. I just want to go back for a second to, this may not be the right term, but I guess the tumor-naive nature of the test. And I was just curious, at each time point, are you detecting, you know, a certain number, hundreds, thousands, whatever, SNPs or, I guess, at the first time point, do you use that information as, I guess, incremental knowledge in the AI algorithm around, I guess, detecting the patient's cancer? So just, I guess, the question more around, I guess, you know, how the, the testing itself works. Thanks. Yeah. Thanks, Tom. I'm going to ask, Marica to take this one. Sure. So, the assay works by using hundreds of SNPs, as you already said, and the algorithm does rely on longitudinal patient testing results. So it's really a combination of molecular biology and AI-derived algorithm that gives you that high sensitivity that ultimately will be patient-specific, but it's tumor-naive, as you pointed out.