Guardant Health, Inc. (GH) Earnings Call Transcript & Summary

Good afternoon. I'm Tycho Peterson. It's my pleasure to introduce our next company this afternoon, which is Guardant. Just a quick reminder folks, if you have questions, you can submit them through the website. And with that, I'll turn it over to Helmy.

Thank you, Tycho, for the opportunity to present today at the conference. I'll begin with a brief overview detailing our Oncology division, and then will hand it over to AmirAli to give an update on screening and close out the presentation. Please note our forward-looking statements. Almost a decade ago, we had a dream that liquid biopsy could be at the center of transforming cancer care across the entire continuum from early cancer screening to recurrence monitoring and to therapy prediction, bringing a powerful new precision oncology paradigm to clinical practice, and bringing to fruition the power of saving lives. During this time, we have pushed the boundaries of what many thought possible and have delivered a new paradigm of care. This transformation is far from over and we are just in its early innings. Three years ago, we made the transition as a company from private to public and promised a grand vision of precision medicine. In those 3-4 years, we not only delivered on that promise, but we did much, much more. We have gone from not having Medicare coverage for Guardant360 to winning TAM cancer coverage and achieving over 200 million covered lives. We achieved the world's first comprehensive liquid biopsy FDA approval went from 40 pharma partners to now over 100 from just starting to work on trials internationally, to now building a global laboratory network as well as imminent regulatory coverage for Guardant360 in Japan. Most importantly, though, we went from the early research phase with our LUNAR programs in MRD and screening to now having well-developed programs and products. We have made great strides and now have administered more than 250,000 tests, are serving more than 11,000 oncologists and are well capitalized with more than $1.7 billion in our balance sheet. Additionally, these achievements have resulted in a remarkable financial track record with strong revenue growth of a 59% CAGR over the last 3 years. The driving force to our work at Guardant is our commitment to putting patients first. And so let me now share a patient story. Veni, a 28-year-old woman, who was pregnant with twins, was diagnosed with Stage IV lung cancer. She started chemotherapy right away and her oncologist ordered a Guardant360 test which identified an ALK fusion, indicating that she may respond to targeted therapy. After doing well for some time and monitoring the patient’s response to treatment, her oncologist ordered another Guardant360 test that detected an acquired resistance mutation to her then current treatment. With this information, her oncologist switched therapies. Veni is now on a 3rd generation targeted therapy. [Audio Gap] delivered healthy twins last summer. Ten years ago, such stories did not have such positive outcomes. Indeed, 10 years ago, we dreamed of a day when liquid biopsies could help guard patients against and shepherd them through and beyond cancer. I can tell you back then, we were unique in our ambition as a company and very few thoughts that such a dream would ever be possible. Today, I am proud to say that our Precision Oncology platform is serving as a critical foundation in transforming cancer management across the entire continuum of care. And our projects are potentially unlocking a greater than $80 billion market opportunity across these 3 areas. This year, we will be the first company to offer clinical liquid biopsy products in all 3 of these significant markets delivering on the audacious goal we set when we started Guardant Health. So how are we able to continue delivering on these ambitious technology goals? By continuing to push the boundaries of what is considered possible. It started with the creation of our digital sequencing platform, which unlocked this first layer of genomic signals you see here, making Guardant360 and liquid biopsy for therapy selection possible. We didn't stop there. Blood, as we know, is a rich landscape of markers. A landscape that encompasses much more than just genomic changes. Over time, we have applied the same technology framework to solve similarly long-standing challenges with detection of increasingly more complex biomarkers in blood. The second layer you see here. This significant evolution of our platform now enables us to unlock most of the salient epigenetic features in blood with unprecedented accuracy such as signatures related to methylation and fragmentomics, among others. And we are not done there. We have extensive research applying the same methodology to unlocking information in the third layer that you see here in this figure. A layer that encompasses similarly rich biomarkers that extend beyond just cell-free DNA, whether it's nucleic acids from other sources, proteins or other markers. And as exciting as our platform is today, we see vast headroom to unlock much more information in the future, all from a simple blood draw. Now I'll dive a bit deeper and give some highlights from our Oncology division. 18 short months ago, we had only 1 clinical product in the market, Guardant360, the world's first and leading comprehensive liquid biopsy. What a difference 18 months has made. We now offer one of the most comprehensive portfolios in Precision Oncology with 5 clinical products now in the market. During this time, we obtained FDA approval for Guardant360 CDx and we launched the next generation of Guardant360. Combined, these products are the most ordered and clinically validated liquid biopsies on the planet with over 250 peer-reviewed publications in support of their utility. We also launched Guardant360 TissueNext, our tissue CGP product that works hand-in-hand with Guardant360 CDx and Guardant360 Response, the first blood-only liquid biopsy for monitoring of therapeutic response. And finally, we launched Guardant Reveal, the first blood-only liquid biopsy for minimal residual disease detection in early cancer patients and cancer survivors. We are thrilled with the strong uptake we are seeing from oncologists of our new products and that excitement is further fueling increased adoption of Guardant360 CDx in a very elegant virtuous cycle. Now I'll give some highlights of some of our newer products. As I mentioned, we recently launched Guardant360 Response, a test that works in conjunction with Guardant360 to detect the patient's response to therapy, including immunotherapies, a median of 8 weeks earlier than a CT scan can. Unlike tissue informed approaches, Guardant360 Response offers excellent performance without the need for a tissue biopsy, offering very fast turnaround times. But it does much more than that. It provides a comprehensive and unbiased view into a tumor's evolution. Guardant360 Response enables oncologists to see their patient's disease as a whole in full color, if you will. The importance of this was recently highlighted at the San Antonio Breast Cancer Symposium last month, whereby results from the PADA-1 breast cancer study demonstrated Guardant360 Response monitoring and its detection of emergent ESR1 mutations resulted in intervention that doubled PFS. Tissue-informed approaches that are tracking a handful of therapeutically irrelevant mutations from outdated tissue biopsies would be blind to such changes. Now I'll detail some of our work in MRD, specifically with Guardant Reveal. The current standard of care in the field are blood-based protein markers such as CEA, among others. These markers can be obtained quickly from simple blood draws but offer poor performance. For example, CEA exhibits performance of the mid- to high-60s for both sensitivity and specificity. More recently, a tissue-based mutation tracking or tumor-informed MRD assays were launched. This approach essentially leverages a simple decades-old PCR-like methodology to detect a handful of hotspot mutations. The challenges with this approach are the long 4- to 8-week turnaround times and the biased nature of only looking for traces of tissue that may no longer be present or representative of the tumor. We launched Guardant Reveal in the clinical practice a little over -- a little under a year ago, and it represents the first true liquid biopsy in the field, whereby no prior tissue information or samples required. It offers extraordinarily high sensitivity, fast turnaround time of days, rather than weeks, and is unbiased, so we can detect recurrence when there are multiple primaries or when the tumor has evolved. Many are incredulous as to how a blood-only liquid biopsy could perform as well or better than a tissue-informed approach. And so Guardant Reveal is certainly pushing the boundaries of what was considered possible for MRD. In a nutshell, Guardant Reveal is able to perform so well, because of the multi-megabase search space that the assay built on and the high sensitivity that epigenomics infers, allowing for hundreds of genomic and epigenomic regions to be detected on average per patient with detective recurrence. This contrast with tissue-informed assays, that despite tracking dozens of mutations, may only detect 1 to 5 of those mutations on average. Finally, while tumor-informed tracking technologies that are at their technological limits of performance, the Reveal platform is just at the beginning of its performance S-curve. We recently launched ORACLE, a study that will pave the way for clinical validation of Guardant Reveal and reimbursement well beyond colorectal cancer. Under ORACLE, we will be collecting samples from early-stage cancer patients across 11 different types of cancers, expanding our clinical study landscape to Reveal to over 70% of all solid tumors. ORACLE with study samples from over 1,000 cancer patients that have undergone curative intent treatment and will recruit from 30 sites across the U.S. and Spain. Guardant Reveal continues to demonstrate excellent performance across multiple cancer types. New data will be presented reaffirming the high sensitivity we showed last year in colorectal cancer of 91% sensitivity in the longitudinal setting with 100% specificity. We are also seeing this excellent performance carryover to other cancers, such as breast cancer. Recent data demonstrated that Reveal achieved 85% sensitivity for distant recurrence with 100% specificity and that the addition of epigenomic markers increased sensitively by 250% over genomic markers alone. Indeed, we are pleased with the uptake we are seeing with Reveal from both clinicians and biopharma partners. In fact, several biopharma companies have performed their own head-to-head studies and have been very pleasantly surprised with the superior performance of Guardant Reveal over tissue-informed approaches. Our Oncology portfolio for existing cancer patients and survivors is now addressing over a $30 billion opportunity. $10 billion of this opportunity is in therapy selection, a market that has grown from $6 billion last year due to the emergence of therapeutic response and monitoring applications as well as addition of our own tissue biopsy product. The recurrence monitoring opportunity has likewise grown from $15 billion to now over $20 billion due to favorable developments and more frequent utilization of such tests in the surveillance setting as well as favorable reimbursement. It should be noted that this $20 billion TAM is for blood-only approaches. Tissue dependent or informed approaches would potentially only access less than half of this opportunity given some of the logistical challenges of accessing tissue, especially in the surveillance setting, many years out from the date of curative reselection. Finally, realizing the large market opportunity takes more than just amazing technology. It takes clinical evidence, regulatory approvals, reimbursement, and above all, a very robust commercial channel. We have built a commercial channel in oncology that we believe is second to none. Our 250-plus person strong commercial organization continues to deliver excellent year-on-year growth. Furthermore, this growth is strongest in the community channel, with 70% of our tests now coming from the community and our growth there twice as fast as in the academic setting. We see this as a testament to the success of our blood-first paradigm that we initiated not long ago, whereby more and more physicians are seeing firsthand the power of using Guardant360 in the first line setting. In our view, this bodes well for years of continued strong growth as other tumor types follow in the path of lung cancer. The products we have in the market today are in a league of their own in terms of performance, product market fit and customer experience. Still, many look at the innovation we have brought to the market over the last decade and wonder if we are reaching the limits of liquid biopsy. They wonder about commoditization as competitors try their best to catch up. And as strong as our lead is today at Guardant, we are not close to finished. We move at our own rapid velocity, motivated by the North Star of patient care. And so what you know today is liquid biopsy is just the beginning. Much like smartphones represented a significant advancement and platform shift from cellular phones of the past. Guardant is about to do the same to liquid biopsies. Today, I'm excited to announce a quantum leap forward in liquid biopsies, our Smart Liquid Biopsy platform. Our first product from this new platform will have capabilities that are profoundly more rich than our current oncology products, drawing on close to 10 years of research and experience from hundreds of thousands of liquid biopsies, our Smart Liquid Biopsy will offer a genomic footprint nearly 100x larger than Guardant360 CDx, provide even greater sensitivity and include comprehensive analysis of genomic, epigenomic and immune signatures among many other capabilities. This new platform, just like smartphones, will enable countless applications over time from deep analysis of tumor genomics, interrogation of the tumor microenvironment, diverse immuno-oncology applications, much more sensitive therapeutic monitoring, identification of complex prognostic signatures and many others. We look forward to beginning to usher in this next chapter of our Smart Liquid Biopsy platform later this year. Now I'll hand it over to AmirAli to update you on our progress with screening.

Thank you, Helmy. Since the inception of Guardant, we have always believed in the promise of blood-based screening to guard against cancer. We believe the path to realize this vision is not by just using off-the-shelf technologies, but by developing a novel and innovative technology stack that can enable detection of cancer signals at early stages with high performance. Our differentiated technology platform analyzes multimodal information cell-free DNA, building on top of our Guardant digital sequencing technology for genomic analysis. We developed a novel integrated assay that can analyze epigenomic signals including methylation and fragmentation changes in cell-free DNA. This multimodel analysis helps to achieve high sensitivity in detecting early-stage disease for diseases like CRC. Now looking into more details of our epigenomic technology. Unlike off-the-shelf, [indiscernible] sequencing chemistries and assays used by most players in the field that damages cell-free DNA molecules through harsh chemical treatment, our novel technology uses an enrichment assay, starting with partitioning methylated DNA first. Then subjecting it to a depletion step, removing the residual nonmethylated DNA to reduce the noise. This enhanced signal to noise improves assay sensitivity and reduces sequencing costs compared to conventional workflows. Our assay enables high-quality multimodal analysis of each single fragment of cell-free DNA versus degraded and methylation-only assay used by many others. Now our philosophy at Guardant for cancer screening. Our philosophy is to build products that will save lives. And in order to really save lives at scale, we need to ensure patients get broad access to such products. Unlike some investigators, who are offering assays with low sensitivity in detecting early-stage disease, we believe we need an assay with high performance in detecting early-stage disease in cancer and also in cancers where early intervention can save lives. We also believe we need to have a reimbursement pathway and have a strategy for inclusion of our screening testing guidelines. The offering needs to be in alignment with value-based care and the objective of health systems. And finally, we believe FDA approval is key in mainstream adoption of the test. As a result, we have focused on CRC as our cancer indication, and we will then add multi-cancer screening application to our installed base. As the first step, we will expand from CRC to CRC and lung cancer screening and then continue adding in many of other cancer types. Double clicking on CRC screening and unlocking $20 billion opportunity here. Blood-based CRC screening has an established Medicare NCD, and a clear FDA approval pathway. The utility of CRC screening is well established, and screening guidelines recommend screening in the vast majority of individuals over age of 45 years old. But the benefit of screening have been limited due to the lack of compliance despite many efforts. The ease of use of blood test holds great potential and promise for increasing compliance through screening tests. We have developed a highly sensitive assay for detection of early-stage CRC. And almost 2 years ago, we started our pivotal ECLIPSE study. Last month, we reached our target enrollment of about 13,000 patients. We expect ECLIPSE readout in mid-2022 this year. We are on track to launch the LDT version of this assay called GUARDANT SHIELD within the next few months and have already onboarded about 100-member PCP commercial team. We expect to submit our PMA package to FDA in the later part of this year and expect to receive approval in 2023, pending successful review by the agency. FDA approval will enable the Medicare reimbursement through our already established NCD. We also expect USPSTF upgrading and guideline inclusion in 2026. We are planning to gradually expand our commercial team to over 700 members throughout this time frame. The ease of use of blood-based screening is clear. Our market research with patients found that 64% of patients prefer blood-based screening over all other screening modalities, including colonoscopy, FIT or FIT plus tests. We also conducted physician research and that understanding adoption of a blood-based CRC screening test across different levels of technical performance. We studied the ranges from Cologuard sensitivity of 92% to 75%, which is about the minimum sensitivity required by NCD for Medicare coverage. Based on the survey results, what we found is we are currently forecasting a very robust adoption for an assay, even with sensitivities in the 80s. We recently reported the sensitivity of high-80s to low-90s for our assay in different early-stage CRC cohorts. Interestingly, even at sensitivities of about 75%, there is still a significant opportunity for blood-based CRC screening tests. In our research, we have not seen any notable dependency to advance adenoma sensitivity in the current PCP market. I'm confident about our strategy of starting with CRC screening as our anchor indication unlocking a TAM of $20 billion. With the expansion to annual screening in high-risk individuals for lung cancer, we believe the TAM will expand to $29 billion. We believe blood-based screening will unlock a major unmet need in average risk lung cancer screening, which expands the market to over $50 billion and increase the interval testing to annual cycles, which will then pave the way for adding many other tumor types as new apps to our screening test. I'm excited about the next-generation high-performance screening test that we are building to enable high sensitivity multi-cancer screening. The original CRC screening panel size was about 500 kilobases and the epigenomic panel size for this new device is about 16 megabases. We've shown the performance of this device in case control cohorts and confirms similar performance in CRC relative to the current device that we have. And also, we confirmed and showed great performance in lung cancer with sensitivity of 87%. We are expecting to show the performance of this multi-cancer screening test in multi-cancer types throughout 2022. To clinically validate the performance of this multi-cancer screening device in detecting lung cancer, we just activated the prospective registrational study called SHIELD Lung of nearly 10,000 individuals who are eligible for lung cancer screening. We will compare the performance of our blood test relative to standard of care low-dose CT scan. We expect to complete enrollment within 36 months. We've made great stride this year across our business execution. This slide shows a snapshot of our performance in Q3 of 2021 compared to the same period last year. We are pleased with our strong clinical volume growth of 35% despite constant COVID headwinds. The rebound of pharma volumes and our solid revenue growth of 27%. As we look ahead in 2022, we are entering a new chapter of Guardant, where we will have offering across the whole continuum of cancer care. Starting from CGP market for treatment selection to response monitoring to MRD and to screening. There are a number of upcoming catalysts for us. To name a few, on the Oncology side, strong ramp of our Guardant Response, TissueNext and Reveal assays, reimbursement wins for these new offerings, global expansion, especially in Japan, and new product launches of multi-cancer review and our Smart Liquid Biopsy platform. And on the screening front, SHIELD LDT launch, FDA approval and CMS coverage and progress toward multi-cancer screening. With that, I would like to thank you all for your time. At this point, I will turn it back over to Tycho for Q&A. Tycho?

All right. Thanks, guys. Before we jump into the business, I just want to make sure, you less revenues for the year, you said $360 million to $370 million. The Street's at $365 million. So any commentary you're trying to make here in the fourth quarter in terms of kind of where volumes ended up?

Maybe I'll jump in Tycho. No, nothing specific. I mean that was our guidance from back of the last quarter. We're not sort of preannouncing our numbers at the moment. But we had a good strong quarter in the fourth quarter. So we're good to still put those numbers out there.

Got it. On the clinical side, CGP penetration is still low in the kind of the single-digit range. Can you just talk a little bit about some of the drivers that are going to be needed to accelerate that penetration? Do you need larger studies, data in other cancers, comparison on clinical outcomes? Or is it just simply waiting for more therapeutic options to come to market?

Yes, that's a great question. We see lung certainly as AvantGuard kind of the canary in the coal mine, so to speak. And -- what we're seeing in lung today is that something like 40% to 50% of lung cancer patients are getting some kind of NGS. Maybe it's not whole CGP, but they're getting some kind of next-generation base sequencing, maybe small panels at academic centers. And so we're really seeing that trend starting to accelerate. And as you hit the nail on the head, what's different in lung cancer, it's that it's the most advanced in terms of the number of targeted therapies and the number of biomarker-driven options. I mean if you look at where we are as a company in lung cancer, we believe we now are the largest tester -- largest CGP tester in lung cancer today. We just crossed that mark. That's among all modalities, tissue and liquid. And so we think that bodes well for, as other cancer types really following the footsteps of lung cancer where CGP is really required in the frontline setting. We think it's a great setup for continued strong growth in many -- in the years to come, but it's just a matter of time. It's a matter of changing physician habits. And as you said, the multibillion-dollar investment that pharma is making today will pay dividends in the future for the need for this type of testing.

And you've had some international updates. We did get a couple of questions on the U.K. and Japan. Can you maybe just touch on how incremental those opportunities are? And does Japan have reimbursement coverage yet? And is that above U.S. rates? And are you just going to be running G360 out of those international labs?

Yes. So we are very excited about what's happening in Japan right now. You may recall that we exercised our call option to essentially take over the second half of our joint venture with SoftBank, which is for Japan, Asia, Middle East and Africa and we're making a lot of progress in Japan. Our lab is up and running there. We're in the final stages of our regulatory approval process for Guardant360. And the next step after that will successful is really a public reimbursement. We're seeing reimbursement rates in Japan in the low thousands of dollars anywhere from $3,000 to $5,000. It's a very large market opportunity, about 400,000 late-stage patients compared to 700,000 in the U.S. And so that's certainly, I would say, the first catalyst in terms of international growth. We are obviously investing internationally pretty significantly outside of there. We're -- as we speak, we're building 2 labs, 1 in Spain with Vall d'Hebron and other the Royal Marsden in the U.K. And we -- ultimately, we think that public reimbursement is really the inflection point for material international revenue. And we believe this strategy of building this global network of laboratories, of partnering with key academic centers, is the fastest way to achieving them.

Maybe you could touch on some of the recent launches. So G360 Response. Can you just touch on traction there? How has the attach rate been in G360? And how do you view it as being differentiated versus Signatera, for example, for Response monitoring?

Yes. No, as we said in the presentation, we really think it's a league of its own. And the traction we're seeing, I think, is a testament to that. The nice thing is we can leverage, as you point out, the significant volume we have with Guardant360, since it's an attachment rate that sits on top of Guardant360. And we're seeing many physicians really kind of latch on it. It really is the way that many physicians are already using Guardant360 and formally. We have now really up that with Guardant 360 Response. It's for all solid tumors. And the beauty of it is that it shows what's therapeutically relevant in a patient's care. It shows what's working, what's not working. And so you really are seeing a full picture into a patient's disease in that metastatic setting, which is so important. It's -- we couldn't be more thrilled.

And maybe a similar question for TissueNext since launch. How much of that volume now is coming from existing Guardant customers versus new customers, who haven't used your products before?

Yes. I think across the board, we're seeing sort of equal traction in same-store sales versus kind of new physician adds. And that's great. That's even with our legacy products with Guardant360. There's a lot of growth, I think, still in the market. But what we're certainly seeing with the TissueNext is that it's played -- I think the thesis we had in launching it has started to bear out, which is it's getting those physicians that were uncomfortable with liquid and with liquid in the first line setting to be able to really kind of move to using Guardant360 in that first line, because they have that safety net of tissue being run in the background. And so we're seeing excellent numbers there. I think we're seeing that we're cutting into a lot of the volumes at some of the competitive tissue CGP companies have out there. Because as we said in the presentation, we've gone from the single product to now this whole portfolio of products, 5 products, and the beautiful thing about them is that they all work together in a very seamless way. So now physicians are, I think, more and more coming on to not just a single test, but a whole precision oncology platform that Guardant is providing to them.

And is it fair to assume you should get CMS coverage pretty quickly for Tissue, just given how established coverage is? I mean does that happen here in the near term?

Yes, it should be relatively straightforward. We're still -- we're in the process.

And then maybe you could just talk a little bit more on the strategy around the Smart Liquid Biopsy. Will this replace G360, and will you roll it out to Reveal screening? How do we think about the opportunity there?

Yes. Right now, it's only in the oncology kind of portfolio in terms of the Smart Liquid Biopsy. And yes, the initial application is around got sort of the Guardant360 therapy selection applications. And it's a way of unifying a lot of what we do there in that portfolio, but really adding a lot of capabilities. When you think about -- we made the analogy to a smartphone versus a cellular phone. And I think a lot of people -- and you think about whether it's TVs or cell phones and so on, those are sort of commodity of the devices, and these are devices that are very easy to commoditize. When you start thinking about smartphones and what is the big leap there, it was going beyond just a phone kind of technology. It was adding GPS, it's adding all these other capabilities, whether it's e-mail or wallets or cameras and so on. And it wasn't the addition of that hardware in itself that really led to the huge utility of smartphones, it was how all of those products could work together within the applications that sat on that ecosystem. It's the same thing here that we're doing with the Smart Liquid Biopsy platform. We're putting tons of capabilities. As we said, it's 100x larger than Guardant360 CDx, but that's only scratching the surface. There's capabilities around epigenomics, immune response monitoring, and other applications, and other capabilities and applications will sit on top of that in countless ways, essentially drive differentiated clinical utility in the field. So we're very excited about even just the initial crop of applications, but many, many, many more that we can't imagine today that are yet to come.

Is there a reason you're not going to roll it out for training, given that you aren't running the assay yet for CRC?

I would say that there's a lot of technology that has, they've been belt for screening that's being incorporated into the Smart Liquid Biopsy platform. It's -- that's really the beauty of this is that we're taking that know-how. We're taking that sort of 10 years of pushing the limits of liquid biopsy towards very high sensitivity in early detection, and we're applying a lot of that know-how to the Smart Liquid Biopsy platform. I think over time, there may be a convergence. But right now, this is really designed for oncology.

Maybe for, AmirAli, just on a couple of questions on screening then. You're launching Shield as an LDT this year. I mean how much of a revenue generator do you think that could be before you get FDA approval on '23?

So in '22 or in general, actually, before FDA approval, we don't expect revenue to be any material -- doing any material contribution to our overall Guardant revenue. And the main reason is we are not going with like business plan of self-pay kind of selling. We really believe that in order to have broad mainstream adoption of a test, you need to go through kind of payors and reimbursement. And since before FDA approval, we have very low expectation of getting some coverage policies. We think revenue contribution would be very minimal.

Got it. And then ahead of the ECLIPSE readout, the ACG data was 93% sensitivity. Any updated thoughts there in terms of where you might end up?

So across different early-stage cohorts and especially early stage symptomatic, I'm excited with a bunch of those data that we've seen. Typically, we are seeing in different cohorts, different presentation, like high-80s, low-90s and going back to this market research that we've done, it looks like the market sensitivity around those performance of even mid-80s, the sensitivity is not much based on their promises of blood-based testing. So we are really hoping that ECLIPSE would confirm the data in the ballpark of what we've seen so far and market is looking for at this time.

Got it. And then will we have data on beyond colorectal this year? I mean you touched on bladder, liver, pancreatic, will we have data on some of those indications?

Yes. So we showed some data in lung cancer and in different conferences this year. You can expect to see much more expanded data sets for lung cancer and few other cancer types. It really works for multi-cancer screening. So we have generated some data and we're continuing to generate a bunch more data.

Yes. And maybe a question for Mike just it came in from investors. But you start giving kind of volume breakouts for tissue, for MRD from G360 for international? How do you think about the granularity you're going to be giving going forward?

I think for the moment, we'll just be reporting a clinical test number. There's a lot of competitive information in there, breaking them out. And we're not seeing a lot of other companies break those out. Maybe in the future, when it starts to become really meaningful and we want to sort of explain what's some of the dynamics of the business, but probably not for the foreseeable future.

Okay. Now I guess there's a wave of newer companies coming on the screening side. Back to you, AmirAli, how do you think about competitive dynamics in this market? Is this a market that could be supported by half a dozen or more competitors on the screening side?

So definitely, the TAM is large, but one thing I would like to emphasize is we believe we are going to be the first compound that gets FDA approval and Medicare coverage for blood-based CRC screening and building on top of that for other cancer types. And this endeavor is not a few months, few quarters, it's a few years. Starting from having a technology that really can offer a good performance in early-stage disease, like off-the-shelf technologies, if you use, you are not going to get the performance we're talking about here. And then going through the clinical validation, ECLIPSE-like studies. This is a multiyear endeavor. So I think the time gap between us and other people, who are coming to this space are in a matter of years from my perspective.

Great. Well, I know we ran a minute over. So I think we'll leave at that. Good to see you all. Thanks for taking time today.

Yeah. Thanks, Tycho. Take care.