Adaptive Biotechnologies Corporation (ADPT) Earnings Call Transcript & Summary

All right. Good afternoon. We're going to go ahead and take it off. I'm Tycho Peterson from the life science team. It's my pleasure to introduce our next company this afternoon, Adaptive Biotechnologies. For those that want to submit a question, there is a link on the website. And with that, let me turn it over to Chad.

Hey, thanks, Tycho. And thank you to JPMorgan for the opportunity to present today. I want to wish everyone a happy and healthy 2021. Obviously, 2020 was a challenging year, but what it do is it put the world on notice about the importance of the adaptive immune system. And that's been really our sole focus at Adaptive for the last decade. And as we start the new year, start the second decade of Adaptive, we're poised to execute on our platform to power the age of immune medicine. So as we briefly move to Slide 2, a quick reminder, this presentation contains forward-looking statements disclosed in the safe harbor slide. So let's get started on Slide 3. So everything we do at Adaptive starts with the adaptive immune system, because it is this adaptive immune system, which detects and treats almost every disease in the exact same way. The information about how it does is contained within the genetics of our T and B cell receptors, which is the source code of our platform. And then our platform, it translates this code and data to enable the development of diagnostics and therapeutics for almost every disease. Slide 4 illustrates how our platform is a clinical product development engine. We're generating massive and growing amount of immune receptor data, which is really at the epicenter of all of our business areas, in life science research, in clinical diagnostics and in drug discovery. We'll be sharing updates with you on each one of these business segments throughout the presentation. But it's really the scalability of our platform and data, which has come into focus. I want to start with a couple of examples. We'll begin with COVID-19 on Slide 5. By elucidating and translating this immune receptor data that's specific to SARS-CoV-2, we were able to develop multiple products. First, as we move around the Venn diagram from left to right, we'll start with our research business, which for the first time we offered a product that not only sequences, but it also maps the immune receptor response to the virus. This product called immunoSEQ T-MAP COVID, it provides a better way for vaccine developers to include the T cell response in their studies. We're really excited that some of the top vaccine developers are getting started and recognized in the power of this product. But second and leveraging the exact same data, we were able to launch a clinical diagnostic called T-Detect COVID to confirm past infection. And third, we were able to stand up an antibody discovery platform to find highly potent neutralizing antibodies against COVID, which is applicable not only to the current pandemic, but also in the unfortunate event of future pandemics. It will have significant utility, and we can apply it to other disease states. So what we accomplished for COVID using these disease-specific immune receptors, it really can be applied to almost any disease. And that's really our path forward. So as we look at another example on Slide 6, we already find this exact same approach in cancer. So today, about 0.5 hours ago, we just announced a partnership with AstraZeneca. And it's the first extension of immunoSEQ T-MAP into cancer, which maps T cell receptors to cancer antigens and AstraZeneca's portfolio of cancer medicines. In clinical diagnostics, we've already been using immune receptor data to monitor minimal residual disease with our clonoSEQ product. And now we're evaluating multiple different tumor types for early and accurate detection in our T-Detect pipeline. And in drug discovery, we have our ongoing broad collaboration with Genentech to develop TCR-mediated cellular therapies. Before I walk in -- walk through each one of these business areas, I want to spend a minute on Slide 7 to address the moats around our business, which -- they differentiate Adaptive and they can create these incredibly high barriers to entry. So first, our technology and applications are clinical-grade, they're FDA-validated, they're protected with over 380 issued and 60 pending patents. Next, our computational biology expertise in immune genetics is truly specialized. And when we couple that with the world-class machine learning expertise that we get from Microsoft, we're able to translate this data at what we call a population scale. In addition and perhaps most important and perhaps underappreciated is a resulting clinical immunomics database. And this is really growing exponentially every single year. And this is enabling us to accelerate our insights into product development. It's a combination of all of these elements together that make us the clear category definer in the immune medicine space. And it's our data advantage that continues to widen the gap. This is truly an open-ended growth story. We're not focused on any one singular disease. We're focused on decoding the system involved in almost every disease. So if we move to Slide 8, this is a slide, I think, that really captures this open-ended growth story. Across all of our product areas, we have development activity underway in various stages in life science research, in clinical diagnostics and in drug discovery. If you think about Adaptive as a clinical product development engine that has the optionality to generate revenue streams from each of these products, whether that be ourselves or through partnerships. I think it's fair to say we're truly in the very, very early innings of what can be accomplished here. Now let's turn to each one of our business areas. I'm going to start with Slide 10 with our research product, immunoSEQ. immunoSEQ is the key component of our platform that enables us to sequence immune receptors. It offers academic researchers and pharma companies a much more sensitive and accurate tool for immune profiling in any disease state that they're looking at. And at the beginning of 2020, we launched our upgraded immunoSEQ research use-only kit. And our focus from that is to be able to expand our reach through partnerships that enable long-term growth. And even in this really challenging environment in the midst of pandemic, we were able to sign 25 core lab partnerships with really well-respected labs. And we also signed our first contract research order, our CRO contract, with Q2 Solutions, and we're looking at many, many more. But in the past, one of the key questions that our immunoSEQ customers have been asking us is not only for the sequence data, but what does it map to, what's the functionality of those T cell receptors, those sequences? And that's what our expanded immunoSEQ T-MAP COVID offering and our immunoSEQ T-MAP offering with AZ in cancer. That's what it offers. And to date, we're already beginning to sequence samples both in vaccine trials and in cancer that is telling just that, what is the functionality and what do these T cell receptor sequences mean? However, immunoSEQ T-MAP, as I mentioned, just doesn't apply to COVID or cancer, it applies to any disease. And so this multiyear pan-portfolio partnership that we announced today with AstraZeneca, it's the second application of T-MAP, but it's also the first pure data play in cancer stemming from the Antigen Map-Microsoft partnership. And so this mapping data, what it can actually do is again inform signatures of immune response to AstraZeneca's cancer therapies. We're super-excited to get this partnership started. So let's move from life science research into clinical diagnostic. We'll start with clonoSEQ on Slide 12. clonoSEQ, it's the only FDA-cleared test to monitor minimal residual disease in blood cancers. And with strong intellectual property protection, it identifies a genetic sequence for each patient's unique T or B cell-mediated cancer, and then it counts the number of these cancer cells at regular time points both during and after treatment. So oftentimes, what happens is the clinician is going to be using a lot of different techniques in all the different lymphoid malignancy disease states to detect relapse. A lot of those or most of which are less sensitive, they're less specific than clonoSEQ, and they can't be run in blood samples. clonoSEQ, it fulfills the need in hematology, because it offers the clinician the potential of using 1 MRD test across all patients with lymphoid malignancies, and it's patient-specific and it's sensitive to 100 million cells. So just in terms of coverage, it's important to note that we secured coverage for 225 million lives in the United States, but they're all in line with our monitoring label that we have from Medicare for acute lymphoblastic leukemia, multi myeloma and chronic lymphocytic leukemia. In terms of adoption, we're becoming integrated into workflow in more and more accounts across the country. clonoSEQ is now used by all 30 NCCN cancer centers by over 180 institutions and has been used to treat over 14,000 unique patients to date. In addition, nearly every major leading pharmaceutical company developing blood cancer medicines are incorporating clonoSEQ into their clinical protocol as the test of choice for any trials in which MRD is a clinical endpoint. It's been integrated in nearly 200 pharma trials of more than 40 pharma partners, and it's got the potential of generating in contract now over $300 million in future milestones that are associated with the product. And so if you take all this together, what this means is it's the confirmation of the clinical significance of MRD testing, but it's also the increasing trust in the clonoSEQ product. Slide 13. It shows the massive amount of clinically relevant MRD data from clonoSEQ and all of the abstracts that were at ASH conference just last month, right? I'll highlight a few of them. So first, there is a real-world study that showed MRD results are actionable in a clinical setting, resulting in better patient outcomes. This is a retrospective review from UCSF that analyzes the result of making clinical decisions to change therapy based on MRD assessments in myeloma. There's another prospective study from Stanford demonstrated that less invasive MRD monitoring in the blood represents an alternative to sero bone marrow biopsies. And the other study I'm going to point out is from Emory, which provides a framework to discontinue maintenance therapy for myeloma patients that have sustained MRD negativity. Meaning if you're MRD-negative for a period of time, you can stop taking the drug. So all of these studies show multiple benefits, including improving the patient journey, better outcomes combined with the reduction of the cost of care. If we move to Slide 14 and we put this all together, you can see that our life cycle and our strategic product plan is purposefully designed to set clonoSEQ up for long-term success. In order to reach as many as possible of the 4.6 million patients globally that are afflicted by these indications, we're focused on 3 main products -- 3 main areas. First, we're expanding into new indications and into blood-based testing. With the launch of clonoSEQ and CLL in blood, we anticipate 2021 to be an inflection year for clonoSEQ as we expect to double the number of patients in our treatable population. For blood-based testing and ALL submissions right around the corner for blood-based testing in multi myeloma, our clinical validation study, it's event-driven. It's still ongoing. And in non-Hodgkin's lymphoma or NHL, we're running several investigator-sponsored trials and also many pharma trials using clonoSEQ. The early data we're seeing actually looks really good. Second, we're increasing awareness for both patients and health care providers. We launched our first direct-to-patient marketing campaign, urging patients with certain blood cancers to just go ask their doctor about incorporating MRD into their care. We're seeing really, really good early results. We're going to continue to invest in expanding this campaign based on what we've been seeing so far. We're also investing in real-world evidence generation with our WATCH registry study that was launched in 2020. And third, we continue to increase our commercial investments to expand clinical adoption of clonoSEQ. We've increased the size of our specialized sales organization and our infrastructure. Additionally, I want to point out that outside of the United States, we've successfully transferred the technology to several different labs, and so they can provide a local testing option. But all this being said, we of course are going to continue to monitor very closely the impacts of COVID on testing volumes. I want to move on from clonoSEQ to T-Detect on Slide 16. T-Detect is one of the most exciting diagnostic opportunities in health care. T-Detect is a T cell diagnosis. It simulates how our body naturally detects disease. From one simple blood sample, T-Detect will be able to accurately diagnose many diseases all at the same time. In order to do this, we use our proprietary platform to link the genetics of our body's immune response to the genetics of many different diseases. More specifically, by leveraging the machine learning partnership with Microsoft, what we're doing is we're mapping trillions of T cell receptors to millions of clinically relevant antigens. And this capability is truly unmatched out there. But I think the reality is in order to get many diseases all at the same time, you've got to start disease-by-disease. We recently launched the first indication of T-Detect, which is T-Detect COVID, and we've confirmed 2 other signals, 1 in Lyme disease, 1 in Crohn's disease. And we're in advanced stages of development in our pipeline for many other diseases as well. So if we move to Slide 17, I'll give you some more details on the T-Detect COVID launch. Just as a reminder, T-Detect COVID is the first T-Detect indication. But as promised, it's been filed with the FDA, and it's pending right now EUA clearance. We hope to have an update on this very, very soon. We're offering T-Detect COVID initially for self-pay consumers, concierge medicine, employers and public health agencies with the goal to confirm past SARS-CoV-2 infection. But importantly, T-Detect COVID may provide insights into COVID-19 immunity, and we're working on collecting that data. For the launch, we're implementing a virtual HCP, a health care provider option within the next week or 2 to ensure that the test can be really easily ordered and conveniently through T-Detect.com. So if you really want to know if you had COVID-19 many months ago, this is -- we believe that this is the only test that can answer that question. But also, as I mentioned, it has the potential to answer a whole lot more questions regarding the immunity. We really do think that it's poised to make a real difference in the virus. So if we move to Slide 18, our T-Detect pipeline, let's zoom out for a minute and look at the T-Detect pipeline. Because this slide, I think, provides a comprehensive vision for the product and how it's going to play out in the future. It's really -- if you think about T-Detect COVID, it's really important to note how much the work on this product has accelerated pipeline development, because we're able to leverage all the learnings and all the work we had to put in place for T-Detect COVID into future indications, including how we more rapidly generate signals, all the software and infrastructure and the ability to educate the FDA at such a great dialogue. But before any one of these indications wind up entering the R&D pipeline, we evaluate multiple indications to select those that have a higher probability of success based on unmet market need, market attractiveness, product fit. And importantly, we also need access to samples that have great metadata associated with it to find the clinical signal. But then we seek the early signals in prioritized disease states, and then we keep continuing to refine our modeling for those that appear promising to bring to market. We also anticipate partnering with large health scale delivery networks to expedite data generation in multiple disease states at the same time. And regarding the long-term vision of T-Detect to become one test with many test results, we see the product evolution in 3 phases, from disease-by-disease to a pan approach and finally into this concept of population immunomics. I want to transition now from clinical diagnostics into drug discovery starting on Slide 20. Our goal is to identify the best T cell receptor candidates for cell therapy and the best B cell receptor candidates for antibody therapies. The process is almost the same as you can see in the diagram. So for T cell therapy, which is shown on the left, we use our discovery and screening technology called TruTCR to find T cell receptors that map to specific cancer antigens. And then what we do is we funnel them down to the ones that have great properties such a strong binding, target killing and those that have minimal off-target effects. It's -- this is our integrated partnership with Genentech, which is focused on developing TCR-mediated cellular therapies in cancer. What we're doing is we're identifying T cell receptors to develop 2 potentially transformative products: a shared product and a private or fully personalized cell therapy product that -- these have the potential to be able to treat many solid tumors. I should -- I want to note too that we're also assessing the application of our TCR discovery approach outside of oncology, including areas such as T cell-mediated cell therapy in autoimmune disorders and in the vaccine space. But for antibody therapeutic shown on the right, we're applying really the same method of screening millions of immune cells to find the best antibody or antibodies that neutralize disease. Using our TruAB discovery process, we've identified several highly potent neutralizing antibodies against different parts of the SARS-CoV-2 virus. We believe our differentiated antibodies have the potential to solve for issues observed with current antibody therapies out on the market now. Turning to Slide 21. We'll talk about our cornerstore partnership -- cornerstone partnership with Genentech. I want to share the exciting progress we're going to be making over the next 12 to 18 months with our pipeline of shared and private T cell-mediated products. Of course, we have a lot more beyond 18 months, but this is the first time that we're going to share details for the next 1.5 years. For our first shared product, Genentech is on track to file an IND this quarter. We're also making progress this year towards completing our second data package for a T cell receptor against another shared cancer antigen. If this T cell receptor is selected by Genentech, this would result in the development of our second shared product using the TruTCR approach. For our private product, we will finalize and deliver our proof-of-concept data to Genentech also in this quarter by screening an identified potent T cell receptors against patient-specific tumor mutations using blood from 15 to 20 cancer patients. This resulting data, we're going to use it to establish a prototype during the second half of this year. Also, as of this month, we expanded our footprint in South San Francisco's Cellular Research lab. In addition, we're delivering a dedicated lab to enable end-to-end personalized product workflow by the end of this quarter, Q1. This space, importantly, it has the capacity to accommodate early phase clinical studies. So net-net, this partnership is working really well, and we're moving full speed ahead with Genentech. So let's switch to our neutralizing antibodies on Slide 22. So unfortunately, it's very likely that COVID-19 is endemic in the population at this point. I'm sure you've heard the virus is mutating. As shown in the past 3 weeks, it's a moving target. It's going to be hard to knock it down. As -- I want to quote Scott Gottlieb, who said recently, the South African variant is very concerning right now, because it does appear that it may obviate some of our medical countermeasures, particularly the antibody drugs. So while vaccines provide part of the solution, we believe that there's going to be a significant need for improved therapeutics because of the limited efficacy against variants and in their difficulty in administration. What do I mean by this, difficulty in administration? Specifically, right now, antibodies are delivered through an IV. But by the time a patient is sick enough to be in the hospital and receive an IV, these drugs are showing that they're having limited efficacy. So at Adaptive, we're focused on a strategy to solve for these problems. First, our powerful technology allows us to search deeper and find more potent neutralizing antibodies against a much wider variation of targets and ones that bind better. For example, the primary focus of therapeutic efforts today have been on the receptor binding region or the RBD region of the spike protein. We at Adaptive have found antibodies against other parts of the virus that we think potentially avoid these mutations or these variants. Second, as you can see on the chart, in addition to covering multiple parts of the virus, all of the antibodies that we have characterized require lower concentrations than any other antibodies that are approved and available. What this does, it allows for exploration of other modes of outpatient administration at lower doses and at lower cost. And so it is for all of these reasons, we believe and we continue to explore the best ways to make our best-in-class antibodies available to COVID patients. Slide 23. I'm not going to walk you through every single one of these, but we have a vast number of catalysts that we anticipate occurring during this calendar year alone. And there's exciting milestones in all of our business area. I think it's fair to say this year shaping up to be the busiest year ever for Adaptive. And bringing us home on Slide 24 and borrowing from our neighbors at Amazon, who said in kind of the mid- 1990s, if you believe in the Internet, bet on Amazon. If you believe in immune medicine, believe in Adaptive. So with that, Tycho, I'll turn it back to you for Q&A with my team. Thanks. Appreciate it.

Great. Good presentation. Thanks, Chad. Maybe I'll start with the Astra news. Just thinking a little bit on the context of 360 and some of the other tests out there for monitoring response to cancer therapies, how do you think you guys will be differentiated?

Harlan, do you want to take that question?

Sure. So sort of -- we'll divide it into 2 parts here. So we are presently generating a lot of data across cancer types at a rapid clip, but the complexity of the antigenic space is quite high. So it will take us some time. But the -- overall, I would say that we believe that the immune system is probably better at detecting disease than we're going to be through trying to create technology to look at the disease directly. So I think there'll be less noise. The adaptive immune system has less noise and it will detect the disease earlier if we could just learn to read that signal. We have the technology to get the information out of the blood. And the question is, can we interpret it to diagnose solid tumors at an earlier stage. And I think we're -- we believe it will happen. It's a matter of time and effort. And we're working hard to move in that direction. Obviously, this is completely different than our direction in clonoSEQ in blood cancers. But in solid tumors, we're definitely moving in that direction. And we're also excited about what the rest of the world is doing. There's a lot of advances coming as well. So we might think about integrating with some of those as well.

And I know it's a pan-oncology partnership, but do you see establishing proof-of-concept across specific cancer types and then eventually rolling out a pan-cancer diagnostic, assuming they move forward with that?

I think from our perspective, yes, we certainly think that there's some pan-cancer portfolio for early detection, literally has the potential to sink the health system, right? The economics can be ridiculous for that. So I think breaking in, in a more targeted way has the potential to be a lot nicer on the system and a lot faster. There's -- you're not subject to the screening platform for trying to get reimbursement. You can go after -- more directly after high unmet medical need if you can pick the right cancer, like, for example, high-risk ovarian cancer patients. So I think there's definitely potential to move much faster and with lower risk if we go after specific cancers.

A question on the neutralizing antibody development programs around COVID. Post the Amgen news, you had the option to kind of shop that to other pharma companies. Can you maybe talk to whether there's been interest? And then, Chad, per your comments on the new strains, has that kind of heightened the level of discussions with potential partners?

Yes. Tycho, here's what I could tell you. We're in active discussions with multiple potential partners. And our strategy in 2021 is to bring these antibodies to patients, and we're looking at several different options to do so. And I -- absolutely right, I think the kind of the recent evidence of variants and mutations is providing a heightened level of emphasis on those discussions. The fact that COVID-19 is endemic in the population is -- and the virus is mutating is a major issue. And I do think the fact that you need to have an IV, there's no -- IV clinics aren't set up to be able to handle in those hospitals. It's just -- they're being administered too late. So we think the game is not over, and there's a lot of room for improved antibody therapeutics.

One that came in on e-mail was just around MRD. And you had some announcements -- Guardant launched today. Do liquid biopsy companies have potential here in hematology around MRD? And if so, how long do you think it would take for them to kind of get into this market?

Julie, do you want to take that?

Sure. So the liquid biopsy companies are doing something different than we do. So the liquid biopsy companies, which we love to see the progress being made there, they're really looking at mutations in the tumor to some degree or shedding tumor DNA in the blood. Our technology is designed specifically to count cancer cells in blood cancers that are T or B cell mediated. Because we look at the T and B cell receptors that are cells. So we're actually counting cancer cells, the actual cancerous cells within these T and B cell-mediated blood cancers. So clonoSEQ would not be applicable in solid tumors. And likewise, we think it's going to be really hard for other NGS approaches that are focused on mutations in the tumor or shedding tumor DNA to do what we do in blood cancers. So they're sort of serving 2 different purposes. I think now the kind of the word MRD might be getting a little bit confusing, because for some number of years now, we've been talking about MRD associated with clonoSEQ and blood cancers. And now that concept has brought into solid tumors, but there is that important distinction.

A couple on just clonoSEQ overall. Clinical volumes, are you able to kind of talk at all about how things have trended since the third quarter? And then as we think about -- you talked about the time lines around multiple myeloma on NHS in blood. But is the label expansion in blood sufficient to drive full penetration in the community care setting in your view and over what time period?

Sure. So we're not sharing specifics, but we had -- we're really proud of the year we had for clonoSEQ, given COVID. We'll share more details on our earnings call. But again, the team did a great job. And ASH was quite a splash, not to make a rhyme, but I think it was really a great showing for the clinical importance of using clonoSEQ across the board for patients with lymphoid malignancies. So we're feeling really bullish about clonoSEQ going forward. Definitely, the CLL clearance and the ability to use blood in our label now will drive penetration into the community centers, and it already -- we're already seeing that traction begin. Full penetration would be enabled by the continued label expansion into NHL as well. But certainly, CLL is a really important start for us and is what's driving our continued belief in this sort of inflection point that we believe we'll see in 2021.

And then do you expect private payer to move pretty quickly here? What's kind of the nature and tenure of those private payor discussions?

Yes. We've actually made really strong progress in the private payer setting. 225 million covered lives under contract. We have another 125 million specific now to CLL and growing. It's important to -- a couple of points. One, we have the Blue Cross Blue Shield Evidence Street, their tech assessment body, gave a positive coverage recommendation. And now that's starting to spread throughout the Blues. So that's a great update. And what we're seeing and we're excited about is that on the private payers, it's all kind of in accordance with this monitoring label, which ultimately means that you get paid for more than 1 test, because MRD is just that. It's a monitoring test kind of post-treatment. So the fact that we're able to get -- see -- the private payers are seeing the clinical utility and paying us for multiple tests is -- I think bodes really well for the setup of the product.

You touched on T-Detect COVID in the presentation as well. How do we think about potential revenue contributions there? Are there plans to pursue CMS reimbursement? And could there be durable revenue opportunities once there's broader vaccine rollout?

Julie, do you want to take that?

Sure. So as Chad mentioned, T-Detect COVID is now available as what we call an early access offering. And the official launch will be coming soon in the next couple of weeks when we have a virtual HCP available as part of the ordering process. And as Chad mentioned, the early access offering was really targeted towards concierge medicine groups and self-pay consumers. In terms of traction, we've already had a few hundred orders, going quite well actually from motivated consumers and some of the concierge medicine groups that signed on -- early on. And so this gives us confidence that there really is demand out there for a test that can tell people with more confidence about their COVID status. And so we are really looking forward to the launch. We're not again sharing any revenue contribution at this stage, and we'll talk more about it in the earnings call, and we'll have some experience with the official launch with the virtual HCP. In terms of reimbursement, we've discussed this a little bit in the past. We did choose to maintain a sort of pandemic price at $150, a self-pay strategy direct-to-consumers so that the future reference price for the overall T-Detect product, which will essentially be used in many different disease states won't be jeopardized. So that's a really important part of our reimbursement strategy, because T-Detect has the opportunity to be used in so many different disease states. We are continually doing a lot of sort of deep dive into the best approach to ensure that the reference price is appropriate for the different diseases where we think we can be helpful.

And maybe a similar question around Lyme. I know you've talked about $600 to $800 pricing on that test. At that price point, how quickly do you think you can penetrate 1 million or so acute Lyme cases? And then what's the reimbursement strategy after FDA approval in 2022?

Sure. So for Lyme, again, we plan to launch in the back half of this year. We'll be filing with the FDA by the end of the year. And pricing is still under assessment. Our current estimates are probably a little bit lower than that, closer to the $500 range. And we're going to continue to do more research. And again, that will dovetail with the same research that's ongoing for future indications to make sure that we really kind of have a comprehensive pricing and reimbursement strategy for T-Detect, because the additional indications are starting to pile on faster now. And so that's all part of the research that we need to do to gain an understanding for the future pricing strategy for the product. In terms of penetration, interestingly, I mean, it's definitely too early to estimate penetration. And again, we'll share more of those details in the future. But as you're probably seeing, and we're seeing even from our first T-Detect COVID launch, there's definitely consumer interest in sort of knowing if they've had COVID. And there's a lot of overlap in conversations in the media all the time now about this kind of convergence between long COVID and chronic Lyme. So I think there's a lot of attention actually being put on Lyme disease now, now that long COVID has become something discussed on a daily basis all around the world. So it's going to be a really interesting future for T-Detect.

And then just rounding it out, as we think about Crohn's and celiac, other milestones we should be paying attention to, when should we expect initial readout from the 1,000-patient celiac study? And should we think about a broader GI syndromic panel or standalone tests?

Harlan, do you want to take that one?

Sure. So for Crohn's, we're bringing in a larger set of case-control studies, so basically patient samples from various parts of the world. And most of those will come in, in the first half of this year. So we'll have readouts and hope to publish those results and present them in the latter half of this year on Crohn's with -- if -- and if the data proves out to be as positive as we're hoping and expecting, then we'll accelerate plans for commercialization. And then on celiac, we'll also be collecting more sample sets and also the larger prospective study that we were running will -- is reading out presently, and we'll be presenting those results also in the second half of this year.

And a couple of...

I should also say, there's many, many other disease states that we're -- have initiated in our funnel and are moving forward at the same time, the whole -- due to COVID and all the learnings that we've got, we've really accelerated our programs. We've learned a lot about our data algorithms, how to extract signal. It's been quite a sort of necessity is the mother of all invention. It sort of helped us progress quite rapidly.

Yes. That was actually one that came in on e-mail. Will the pace of disease targets increase, given the collection of all the data? So it sounds like there is kind of...

Absolutely, increasing significantly due to our sort of massive thrust and the accessibility of so much data in one disease state, we were able to really assess in a more holistic way how to go from soups to nuts in a way we would have taken a much, much longer time frame to be able to do what -- had there not have been such unbelievable sort of the whole research community came together to really attack COVID.

Also, consistent with the launch of -- Tycho, if I could just add to that. Consistent with the launch of T-Detect, we're going to be allowing the customers to be able to opt into future research as well. So not only we're getting the biologic specimen, but also the opportunity for them to participate in future research as well, so continue to build out that database.

A follow-up that came in on just MRD and liquid biopsy dynamic, the question is, couldn't they quantify ctDNA and translate it into sales? Would that be, I guess, a competitive threat?

Yes. So maybe in some cases -- the issue there is -- so for example, for multiple myeloma, ALL, CLL, we're really counting the DNA directly from the cells themselves. So we're getting an absolute count of the cells in a very precise way. If you're using cell-free DNA and looking at mutations, you're at best getting an extremely indirect count that's not going to be -- have the same level of precision, number one. And number two is that you have to deal with all sorts of background noise that you don't -- because you can make those mutations a subset of those in healthy cells or just randomly. Whereas to get a precise receptor sequence, the full receptor sequence is virtually impossible to do randomly. So we have almost no noise in our assay for MRD. So this sort of the level of precision is something you can never get with these other assays. And it would be great if there was an equivalent in solid tumors. There are just not. So like we'd love if we could -- basically adaptive immune cells, T and B cells are the only cells that rearrange DNA to create their own internal barcode to have a very special precise tag. So that's what separates out lymphoid cells.

Great. Maybe one last one in closing just around drug discovery. Chad, you kind of alluded to the potential for a second package with Genentech that could look like the other program. What are the odds of that? And then could we get an update on the prototype development for the personalized cell therapy product? What is the vein-to-vein time? And what would allow you to move faster there?

Sure. I'll cover the first, and then maybe I'll pass it to Harlan to cover the personalized. So just in terms of handicap, we found great T cell receptors against a shared cancer antigen that's of mutual interest. And we're excited about the prospects of Genentech moving it forward. Obviously, it's their decision. So we don't want to be definitive here. But I'll just say, we're enthusiastic about the opportunities that lie ahead for the second. And potentially, beyond that, we're going to continue using TruTCRs to find cell receptors against many shared antigens if this is working how we think it's going to work. And at the same time, which Harlan is going to allude to, the strategy is progressing quite nicely on the truly personalized approach.

Yes. So on our personalized approach, we're opening a new lab in San Francisco that's going to be the end-to-end prototype to be able to pull out the T cell receptor specific for any given patient's cancer in real time. And we're aiming to have that prototype nailed down, both with -- on our side and then on the Genentech side for actually implementing it in the cellular therapy on the cell side by the end of this year so that we can move into IND filing in 2022. It's progressing very well. I think we're all excited about the direction it's going. And maybe we'll hit some hiccups, but so far, it's been pretty good.

Great. We're going to have to leave it at that. Thanks for taking the time. Enjoy the rest of the conference. And talk to you all soon.

Thank you again, Tycho.

Thank you. Bye-bye.