Good evening, everyone. I'm Sebastian Sandler with the Life Science Tools and Diagnostics team at JPMorgan. I'm pleased to be joined by the Adaptive team. This is going to be a 40-minute session with roughly 20 to 25 minutes of presentation, followed by Q&A. If you have any questions, feel free to submit them via the app, and with that, I'll pass it over to Chad Robins, CEO and co-founder of Adaptive.
Thanks a lot, Sebastian, for the opportunity to present once again at J.P. Morgan. Happy New Year to you. Welcome to those of you who are in the room and for those of you who are listening in on the webcast. As a reminder, today we will be making forward-looking statements both in the presentation and the Q&A session to follow. For those of you who are new to Adaptive, we spun out of the Fred Hutchinson Cancer Center 15 years ago with a mission to translate the genetics of the adaptive immune system into clinical products to both detect and treat disease. We went public in 2019, and today we are over 625 employees focused and organized around two distinct business units. The first is Minimal Residual Disease, or MRD, which is a pure-play commercial-stage diagnostic company.
It is driven by our clonoSEQ assay, which today is the gold standard for MRD in blood cancers. The other unit, called Immune Medicine, or what we call IM, is an early-stage drug discovery business with massive potential in the field of personalized medicine, particularly in autoimmune disorders and in cancers. Before getting into the details of each business, I want to highlight our cash position. Our estimated cash at the midpoint of our 2024 guidance is over $240 million. Importantly, this cash on hand will allow us to achieve two main goals. The first is to bridge our MRD business to profitability in 2025 with a healthy growth and margin profile. The second is this cash will allow us to make targeted investments to advance our discovery efforts in IM for high potential future value.
As shown in the chart, we have managed to reduce our cash burn significantly year over year as we have increased our cash revenues, reorganized our workforce, and implemented company-wide operating efficiencies. In 2024, we reduced burn by over 30% from 2023, and we look to further reduce our burn in 2025. With that said, now let's look at each business and the respective outlooks, and we'll start with MRD. MRD is our commercial-stage diagnostic business, and its flagship product is called clonoSEQ. I want to give you a little info on what it is and how it works first. clonoSEQ is the most sensitive test in blood cancers and can detect one cancer cell in every one million healthy cells that remain in a patient's body both during and after treatment to inform clinical decision-making on a patient.
The clonoSEQ test identifies the genetic sequence for each patient's unique B or T cell mediated cancer at diagnosis and then counts the number of cells left in a body during the course of a patient's care for monitoring. clonoSEQ is the only FDA-approved test for MRD which supports the sensitivity, reliability, and reproducibility necessary for MRD testing. clonoSEQ is not only used in the clinical setting, but it is also used with biopharma companies that are developing blood cancer drugs. These businesses are absolutely synergistic and combined drove over 40% revenue growth last year. Clinical testing represents about 60% of our revenue profile. The test has exceptional coverage with over 300 million covered lives, and we've got 65 reps in the field targeting both academic and community centers. Biopharma trials represent 40% of our revenue.
clonoSEQ is now used in over 170 active trials and is used in a clinical endpoint in just about half of them. So zooming in to clinical testing. So in the clinic, clonoSEQ is absolutely the leader in MRD testing for blood cancer patients. Clinical volumes have consistently grown over the last five years with a cumulative average growth rate of 46%. 70,000 unique patients have had a clonoSEQ test ordered by approximately 40% of hem-oncs in the United States. Yet it's still early, and there's a lot of room for growth. Our penetration rates are still low in all indications, and we have many years of growth ahead of us in all marketed indications, especially as the evidence continues to mount to change clinician behavior. Again, in 2025, we expect multiple myeloma to be the largest growth driver. Let's now zoom into MRD pharma.
The story here is also very similar. clonoSEQ is the test of choice for pharma trials in blood cancers. The number of studies where clonoSEQ is used as an endpoint has been growing year after year. Today, there are 86 active studies using clonoSEQ as an endpoint. 14 of those are primary, and 72 of those are secondary endpoints. Just as in the clinic, there are significant growth opportunities ahead in pharma in all marketed indications as the path for MRD use as an endpoint continues to emerge. Now that I've set the stage for our current position in MRD, I'm going to drill down into our key priorities going forward to drive both our top-line growth and our bottom-line margin improvements. Revenue growth on the clinical side will be driven by both volume and ASP increases.
Pharma growth is expected to come from new studies, many of which will use clonoSEQ as an endpoint. Margin improvements will be driven by continuous efforts in the lab to lower production costs per sample and by leveraging our existing infrastructure as our volume grows. So let's look at each of these categories and do a drill down. So first, let's talk about our volumes. Clinical volume growth is driven by a combination of many different factors. One is blood-based testing. So why is blood so important? Well, it seems logical, but I'm going to hit it anyway. Blood is much less invasive to a patient and therefore will increase the frequency of the number of tests per patient. Today, about 40% of all clonoSEQ testing is done in the blood. And we anticipate by the year-end that over 45% of all tests will be in the blood.
This is really very synergistic with our efforts to expand our usage in the community setting, where if you look at it, 60% of patients with blood cancers are treated in the community, and the majority of those tests are performed in the blood. Moving on, another key factor is the integration of clonoSEQ within EMR systems, both in institutions and community centers. This will expand access and really increase the ease of use. If you think about it, a doctor, instead of having to go off their EMR system into a portal, is a difficult workflow. When we integrate, we expect the ease of use to really increase the utility of clonoSEQ. Throughout 2025, we expect to integrate a lot more Epic accounts. We've already integrated 19 Epic accounts, which started in the academic medical center.
And importantly, in the second half of 2025, we're going to launch our integration with Flatiron Health's OncoEMR system that will give us access to over 100 community centers. So if you take all this together, kind of by the end of the year, we expect to increase that number from 20% ordering in EMR-integrated sites to over 50% of orders will come from EMR-integrated sites. And perhaps the most important factor in continued volume growth is data generation. Last month at ASH, clonoSEQ had the most amount of data ever presented, with over 69 abstracts across all marketed indications. It was interesting that this year we really had a tipping point where many of the abstracts showed that MRD actionability, leveraging increased sensitivity of clonoSEQ at one in a million, really, really mattered for clinical utility.
For example, an MCL study indicated that transplantation may not provide additional benefits to patients in molecular remission at a level of one in a million cells. So this data has been viewed, and we've been told by many MCL practitioners that this is practice-changing in the field. We're also involved in over 80 investigator-sponsored trials across all indications, as highlighted in the chart behind me. For example, the MIDAS study. It's an 800-patient study in multiple myeloma using MRD interventionally in the frontline setting. We will continue to invest and develop data to demonstrate how a doctor can change practice on a patient based on the information we provide with a clonoSEQ test.
To further solidify and grow our leadership position and our volume growth, this morning we announced an exclusive strategic commercial partnership with NeoGenomics to cross-promote our clonoSEQ test with Neo's Compass and Chart Heme services. Compass is Neo's diagnostic evaluation for patients, and they will automatically include a clonoSEQ test at the diagnostic workup. That's an initial diagnostic. Then the subsequent chart reports from Neo will automatically include a clonoSEQ MRD test during the monitoring phase for a patient. Right now, Salesforce training is happening, or it's about to start happening because we announced today. Then we expect our cross-selling efforts to begin in the latter half of this year. We're super psyched about this partnership.
We think these two companies are the leader in heme, and we want to bring our test to as many patients as possible to improve their care. So now let me flip over to the other side of the equation, which is to increase our clinical revenue, which is ASPs. Last year, we had a really big win, which fundamentally changes the trajectory of clonoSEQ. So Medicare set a new gap fill rate of $2,007 per test in all of our covered indications, which has been in effect since January 1st of this year. So this represents a 17% increase from our previous rate of $1,700 under the previous episode structure. So this is not only going to help with Medicare directly, but it's also going to help with our commercial payer contracting.
Other things that we're doing for ASPs. We're increasing our investments in rev cycle management to improve our collections. So we're specifically targeting prior authorization process and the appeals process. We're automating those functions. In addition, we expect to shift our product mix away from Medicaid to Medicare so we get a higher dollar ASP. So if you take all of these initiatives together, we anticipate ASP will reach $1,300 per test on average for 2025, which represents a 24% increase from 2023 in the last two years. So in addition to clinical, MRD revenue growth is also looking extremely promising. We had another big win in the pharma business. Well, actually, most importantly, this was a very big win for patients.
Last year, the ODAC recommendation in favor of using MRD as a primary endpoint to support the accelerated approval of new therapies for multiple myeloma patients was really a major milestone in the field, the first new primary endpoint in many, many years. And as shown in the data presented at the meeting, there is an indisputable strong prognostic value of MRD status. And actually, the clonoSEQ data was used for the ODAC recommendation. So what does this take together? What does this mean for Adaptive? There is going to be a really nice positive halo effect for both our pharma trials and our clinical testing businesses. Starting with pharma, we closed 20 new myeloma studies last year, 15 of which were closed just post the ODAC recommendation. We've also seen an increase in MRD use as a primary endpoint in multiple myeloma.
We've got 10 multiple myeloma studies now using clonoSEQ as a primary endpoint. Two of those were recently signed, and three of those studies converted from a secondary to a primary endpoint, again, just since ODAC, and if you think about it, what we're seeing right now just makes sense, which is this kind of positive halo effect of companies developing blood cancer drugs and other indications such as CLL and DLBCL in anticipation that the FDA, hopefully quicker than in multiple myeloma, will allow for a primary endpoint for accelerated approval of those therapies and get them to patients quicker, so as you can see, we've got great momentum in the pharma business as well. Now, let's look at the cost side of the equation to enhance our margin profile, so during 2024, we lowered overhead costs as a result of workflow improvements in the production lab.
In addition, as volume grows, we will continue to get leverage from our direct labor personnel, which we have kept stable. One of the most important initiatives to reduce costs this year is our shift in sequencers from the NextSeq to the NovaSeq X, which we expect to go live in the second half of 2025. In the first 12 months post-going live, we expect a 5%-8% margin improvement just attributable to the NovaSeq X. After that, as volumes grow, we expect that we could have a 10% plus margin improvement. So in addition to these improvements in the production lab, we plan to maintain similar levels of 2024 operating spend, which will drive operating leverage and volume growth. So wrapping up MRD, our leadership in MRD heme is strong.
The consistent results that we keep delivering quarter after quarter and the execution of these strategic priorities will give me great confidence that we will hit our profitability goals of EBITDA profitability at the end of this year with a very strong growth and margin profile. Now, let's switch over to the other side of our business, which is immune medicine. Our immune medicine business is pursuing two differentiated immune-based therapeutic strategies. One is our partner program with Genentech and our wholly owned program in autoimmunity with our own precision immunology approach. So what are we doing in cancer? So our partnership focuses on the development of a fully personalized TCR-based cell therapy to treat patients with many different solid tumors. So our role at Adaptive is to identify the best set of patient-specific TCRs that target each patient's individualized or unique cancer mutations.
We then hand those TCRs over to Genentech, and they take these Adaptive discovered TCRs and engineer them into T cells to manufacture and develop a fully personalized cell therapy product for each patient. So we have shown that we can do this with our cellular assay, and we've successfully confirmed that we can identify patient-specific TCRs to a patient's unique tumor mutations. However, cellular assays as part of the personalized workflow is both costly and time-consuming. So to really scale this product, what we're moving to is an in silico or a digital solution. So there's been a bunch of stuff happening that are really coming together right now that make this possible.
So we're leveraging the massive increases in compute power, the recent advances in kind of protein folding, and our own computational and statistical methods to really build what I'll call is the missing component, which is a training set of TCR antigen interactions. And Adaptive is uniquely positioned to do this. We're actually making phenomenal progress, and it's going faster than we expected. To date, we've actually generated a significant portion of this training set and have in parallel been using and refining our algorithms to use this training set. The first use of this digital, I'll call digital or in silico model is for the Genentech program, where instead of having to do a cellular assay, we can sequence a patient's mutations and sequence their immune repertoire or TCRs and use an algorithm essentially to match those up.
That'll massively reduce the time and cost to deliver a cellular therapy product. So we look forward to providing an update on this at the appropriate time. And we're really excited about the progress we're making with Genentech. So now let me shift to our wholly owned programs, which are in autoimmunity. In this case, we're targeting the disease-causing T cells that are able to identify with our powerful sequencing and statistical methods. So the problem, like the macro problem in autoimmune disorders, is that there's really no targeted therapies. And it's really been challenging because both the disease-causing T cell receptors and the antigens to which they bind are unknown. We are solving this problem. So to date, we've identified a subset of autoreactive or kind of the disease-causing or problem T cell receptors that are likely causing many different autoimmune disorders.
We’ve subsequently discovered the protein to which these T-cell receptors bind. With that, we’ve recently completed several antibody immunization campaigns, and we’ve successfully selected and functionally tested a subset of antibodies to a number of these disease-causing targets and prioritized indications. Based on these data, we recently nominated a lead indication. Just to be clear, our therapeutic strategy is to develop an antibody that blocks or depletes the T-cell receptors that are disease-causing in these autoimmune disorders. Our focus in 2025 is to develop a robust preclinical data package that warrants further investment in our first differentiated TCR-blocking antibody program. We’re super excited about the progress that we’re making in Immune Medicine and a lot more to come on that front.
So in summary, and just to kind of wrap this up, Adaptive is well positioned for success in both minimal residual disease and in immune medicine. And there's really, if you look at it, kind of different factors in those success. MRD is all about continued execution and the drive towards profitability at the end of the year with a great growth in margin profile. IM is all about advancing our drug discovery business, which we believe could have enormous future potential. And we will do this with commitments around our cash spend. We're committed to not only supporting the Genentech program, but also developing our autoimmune wholly owned programs with a cash spend of, excuse me, a cash burn of $25-$30 million. So just kind of wrapping this up, the setup for 2025 is excellent, and we're getting after it. So really appreciate your time today.
And with that, Sebastian, I'll turn it back over to you, invite my team up here to answer questions. So come on up.
Maybe one more chair over here. You guys can ask questions.
Great. That was a great overview. Thanks, Chad. So as you mentioned, 2024 was an eventful year for Adaptive for various reasons, including the strategic review completion and the FDA ODAC decision. So just to kick things off, can you reflect on the past year and talk about some of the major insights you've gathered and how you see Adaptive's current standing and future outlook compared to this time last year?
Yeah, sure. I'll start. I think we're extremely confident that we're going to get to profitability in our MRD business, and we've made great advances in autoimmune. If you look at the last year, the two things that you're talking about, impactful things that I mentioned them, I'll highlight them again. One is kind of this ODAC decision by the FDA. This is resonating across the industry. Essentially, for lack of a better term, the use of a biomarker as a primary endpoint is really special because it's going to provide accelerated approval to patients. And at the end of the day, we're all here to essentially make life better for patients. So that's great. And the second is one of the hardest things in the business of the diagnostics business is kind of the market access front. And having more certainty around pricing is a great thing.
So we're really kind of confident in our ability to kind of increase our ASPs. And Susan's a wonderful lead of the business, and she's been really driving volume and putting the right strategies in place. So I'm psyched about that. And then on the Immune Medicine front, we're really excited about the data that we're seeing. And I can let kind of both Harlan and Susan expand on any of those.
All right. We'll get through it if there's questions.
Yeah, [inaudible]. All right. Looking ahead, consensus for MRD top line in 2025 is around 26%, which is a step down from the 40% top line growth assumed in 2024. Can you walk through how comfortable you are with where consensus is at? And then some of the maybe the long-term drivers that could maybe get that growth back towards the historical four-year CAGR growth around 46% that you laid out in the presentation?
Sure. Susan, do you want to take that?
I'd say that we're comfortable with where the consensus is at today. We have confidence that we'll continue to grow the business at a strong rate. We have a number of drivers that we look forward to utilizing in the MRD business. For example, continued EMR integration progress, the partnership that we announced earlier today with NeoGenomics, advances in our data. We have several, as Chad pointed out, several key data sets that will become available this year. We'll provide final guidance in February.
Yeah. I think the point that she pointed out, it's not one factor. There are many different levers of growth. We're hitting on all of them, and we're not only looking to get there, but we're looking to exceed. We'll see.
Great. So after concluding your strategic review in April of last year, you talked about maintaining optionality for the IM business. So for people who are newer to the story, as we move into 2025, can you talk about your thoughts on the future direction of IM and how that ties into the MRD business and Adaptive as a whole company?
Sure. I'll take the second part. If you want to take the first part about the IM business, I'll talk about how it ties in.
Sure. So we've really decided which programs that we're going to take personally and which we're going to, as a company, and which we're going to partner out. So we've had a lot of internal clarity, which has been extremely helpful. And the fact that that opens up so many other directions that potentially we can partner out, it really is where the optionality comes in, I think, in our book. So as Chad was saying, we're developing a training set for what could be a quite powerful model that I think will have a lot of utility across the board, which also increases optionality in terms of we're already getting significant inbound interest for utility of that as well.
So I think across the board, I think we're definitely excited about where we're at right now and what we're learning quickly, and especially in the autoimmune space where the field is probably 20-30 years behind where the cancer field is in terms of understanding the science. But we're really pushing the boundaries there, which is leading to all sorts of, I think, interesting innovations that we'll see materialize in the coming years.
I realized, and I apologize, I didn't make proper introduction. So that's Harlan Robins, my brother, my co-founder, and the Chief Scientific Officer of Adaptive. Susan Bobulsky is the Chief Commercial Officer and runs the MRD business. And just to frame this in context, for immune medicine, with a limited amount of spend, we look at it as this is a low-cost call option on an extremely high-value opportunity. And at the end of the day, I said we're the net cash burn of $25-$30 million. And who knows, over time, we could even close that gap based on partnerships and deals. So really excited about the science, and I think we can do this in a very cost-efficient manner, again, for a very high opportunity value upside.
Great. So I want to dive a little deeper into clonoSEQ and some of the opportunities there. So penetration varies by indication. You've talked about how DLBCL represents around 35% of overall test mix, but it's only 3% penetrated. So can you talk a little more about what drives penetration there and why penetration has been a little slower to pick up maybe compared to other indications?
Sure. So first, I will say that DLBCL, among other NHLs, are an important opportunity for us to continue to grow the business. Newer indications for us, importantly. So if you compare penetrations in myeloma or ALL, which have been FDA cleared since 2018, we launched DLBCL in December of 2022. So penetration, we've actually been quite pleased with the trajectory. It's aligned with our expectations, and we grew 80% year over year in DLBCL in our second year on the market versus our first.
As far as the trajectory, I think I'm comfortable with it, and I expect that we'll continue to see significant growth year over year in 2025 as we leverage additional studies, as pharma companies continue to explore MRD-directed approaches to treatment, and as we pursue some of the other key drivers in DLBCL, which include data generation in the frontline and surveillance settings, expansion of guidelines. You may have seen that recently the NCCN updated guidelines to include MRD in the context of PET-positive patients at the end of therapy for patients who have difficulty getting a biopsy. It's a narrow but important beachhead for MRD in that setting. Additionally, pursuing and progressing our regulatory strategies and expanding our coverage with commercial payers. All those things will help us to continue to drive DLBCL penetration in 2025 and beyond.
Great. So you also talked about how certain indications are weighted more towards Medicaid than others. So as you penetrate into other indications and maybe shift mix away from Medicaid, should investors expect a meaningful improvement in gross margins as you shift away?
Oh, go ahead.
We do expect to shift the mix away from Medicaid and toward more Medicare. That'll come from a number of strategies, but most importantly, just the improvement or the increase in contribution from the community setting, which is a more Medicare-heavy population. We expect to bring it down from around 12% between Medicare and self-pay today to around 8% in 2025, and we do expect that to be one of the factors that will contribute to our gross margin improvements.
Great. I want to take a step back and look at the growth strategy for clonoSEQ. So can you talk about how the strategy there has evolved as the assay has matured and the market has matured and whether the strategy varies by indication and any color on that front?
Sure. So I would say that our strategy has been relatively consistent over the last number of years. We've focused importantly on expanding the indications for which clonoSEQ is clinically available, expanding coverage, increasing utilization in the community, and increasing utilization in blood. But we have also, of course, continued to, as the business matures and as the market landscape evolves, we've continued to assess whether there are ways that we can expand our strategy or evolve it.
A couple of examples of that were a couple of years back reorganizing our sales team to have both community and academic reps in separate teams to focus on those segments, expanding our investment or investing significantly, I should say, in EMR integration, which began about 18 months ago, and also investing more heavily in revenue cycle management, which has been a key component of our effort to accelerate the growth of our ASP.
Great. Yeah. So speaking of integrations and EMRs, and you also talked about your efforts in the community setting. So can you talk about how those efforts have progressed? You have the Flatiron integration coming up, so maybe talk about that as a growth driver and then also how we can expect these to impact SG&A expenses moving forward.
Sure. So we've been delighted to partner with Flatiron. We kicked off the project in Q4, and we've made considerable progress in designing the interface and thinking about exactly how we'll implement as well as identifying accounts that we can pilot with prior to the broader launch. We are anticipating going live with Flatiron in the second half of the year, and it'll give us access to over 130 sites who utilize their molecular profiling integration suite, which is the tool we leverage, the platform we leverage through their system to integrate. It's a go-live all at once as opposed to our Epic, which is a one-by-one approach, and so we'll have access to those accounts and are looking forward to driving business there. We also have a handful of, I'll call them bespoke integrations with large community practice networks who utilize systems other than OncoEMR and Epic.
Those will be important drivers too as a considerable amount of our business, as much as 10%, comes out of those types of large community networks.
Great. So your presentation talked a little bit about the NovaSeq X transition, which is going live in the back half of 2025, which should drive some margin expansion. Can you provide a little more color on the cadence there? Should investors expect any meaningful expansion in the back half of 2025, or is it more of a longer-term dynamic?
Sure. I mean, I'll just reiterate. I think in the first 12 months post go-live, we're looking at a 5%-8% margin expansion. The rest of that depends on how fast volume grows, but we anticipate a 10% plus after those first 12 months.
Great. And then your gross margins, you're guiding improving to around 56%, up from 43% in the first quarter of 2024. Can you talk about Adaptive's long-term trajectory toward that around 70% gross margin profile for the MRD business?
Yeah, sure. I mean, it's a combination of all the factors that we talked about, both on the top line in terms of revenue growth. You got revenue growth, and we're trying to reduce costs at the same time. So it's the NovaSeq, it's really operating efficiencies in the lab, it's keeping spend stable as volume grows, so being more efficient with direct labor personnel. It's all these things together that will really increase our overall gross margin to that 70% at scale.
Great. Maybe we'll touch on ASPs for clonoSEQ. So in 3Q and during presentation, you noted that clonoSEQ ASPs, you expect to be around $1,300 on average in 2025, which could exit the year above $1,300. So can you walk through some of the puts and takes to drive the ASP above $1,300 exiting 2025?
Yeah, go ahead.
Sure. Yeah, so that's correct. We are anticipating about a $250 increase from where we stood in 2023 for the full year on average. About $200 of that comes from our ongoing initiatives to expand coverage, to increase the number of contracted payers, and to improve our revenue cycle management to optimize payments, as well as the shift, by the way, in the mix of payers. The additional $50 comes from the updated gap fill rate, which we'll see immediately, the impact on our Medicare fee-for-service business, which is about 20% of our business. And then over time, the impact pulled through to our Medicare Advantage, as well as the opportunity to negotiate with our commercial payers, both our existing contracted payers to renegotiate and our in-progress contracts to bring the gap fill rate to bear in those negotiations.
Great. So I also want to touch on the ODAC vote, which, as you mentioned, was a huge event for patients and also Adaptive. Can you talk a little bit about how much upside you see to the backlog from this decision and even taking a step back, just maybe expectations around timing for a final FDA decision?
Yeah. So as Chad pointed out earlier in the presentation, we saw a total of 20 new myeloma studies booked in 2024, of which 15 came after the ODAC study. We have also seen significant halo effect in the clinic, as well as in other indications where both pharma companies and clinicians are looking to this as sort of a measure of the credibility of MRD and as a potential tool that can be leveraged in other settings. We are anticipating that the FDA will probably not issue any sort of a final rule. It seems, in fact, that what they'll do is allow the companies to continue to approach them on a case-by-case basis. And I think the important thing to note is that we're uniquely positioned to take advantage of this recommendation because of our status as the only FDA-cleared test in the space.
So we'll continue to work with our pharma partners. We do expect there to be a long tail to the impact of the ODAC vote.
Great. Are you able to quantify at all the impact of this halo effect on the clinical volumes or provide some sort of guide or anchor to how we should think about biopharma volumes flowing through to clinical?
I think it's hard to quantify any one thing in isolation, but if you, again, taken together, that's what gives us really strong confidence that we can hit or exceed what's kind of laid out in terms of the growth profile of volumes for next year. But certainly, we see it as a factor. As Susan was mentioning, we have a lot of clinicians right now that had never wanted to talk about MRD that are proactively reaching out to Adaptive based on the ODAC recommendation.
And I do think that as we see more MRD-directed therapies come into the marketplace, which could happen soon, as I understand it, as early as in the next year, major therapies with trials that will potentially enable a registration around an MRD-directed use case. And in that setting, I think it will become easier to start to quantify the impact on the clinical business because it'll be a bit of a more direct line between the approval and the utilization of the test.
And one more point. I mean, if you look at kind of 2024 last year as opposed to 2023, myeloma was starting to be a very crowded field, and some of the large companies were starting to kind of step away from their multi-myeloma programs. And some of those were reinvigorated and reinitiated based on the ODAC recommendation.
Great. You talked about the data that Adaptive presented at ASH quite a bit, I think more than 65 abstracts. Can you talk about some of the feedback you received from physicians on that data?
Sure. The mantle cell data, ECOG-ACRIN 4151, which demonstrated that MRD-negative patients can avoid a transplant and that MRD-positive patients may benefit from a transplant, certainly described as practice-changing by a number of thought leaders and will, I think, be quickly integrated into clinical practice. The CLL data that showed an example of shortening the duration of a fixed-duration regimen in the context of an MRD positive at the end of cycle nine, so shortening by three months or by 25% the total duration of the therapy, that was received favorably, although I know there are larger ongoing studies that will kind of build on that and will likely be necessary to fully move the needle on clinical use.
And then lastly, I think in multiple myeloma, numerous studies, including another primary endpoint study that read out, showing that 10 to the negative sixth sensitivity is important to understand the depth of response of these novel therapies and combinations, as well as the importance of sustained MRD negativity to assess a patient's long-term prognosis.
Great. I think with that, we are out of time. Thank you so much for coming. Thank you all for being here, and enjoy the rest of the conference.
Thanks, Sebastian. Appreciate it.
Thank you.