Good afternoon. I'm Michael Peterson, Smart Money. I'm here 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. With that, I'll turn it over to Helmy.
Thank you, Michael, for the opportunity to present today at the conference. I'll be giving a brief overview detailing our oncology division, and then we'll hand it over to Amir Ali, who's going to update on screening and close out the presentation. These notes are forward-looking statements. Almost a decade ago, we had a dream that liquid biopsies could be at the center of transforming cancer care across the entire continuum, from early cancer screening to recurrence monitoring, into therapy selection, 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 three short 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 pan-cancer coverage and achieving over 200 million covered lives. We achieved the world's first comprehensive liquid biopsy FDA approval, went from 12 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 and MRD 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 on 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 three years. The driving force to our work at Guardant is our commitment to putting patients first. Let me now share a patient story. Zeni, 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 alteration 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. Zeni is now on a third-generation targeted therapy. She delivered healthy twins last summer. 10 years ago, such stories did not have such positive outcomes. Indeed, 10 years ago, we dreamed of a day when liquid biopsies could help Guardant patients again 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 thought 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.
Our products are potentially unlocking a greater than $80 billion market opportunity across these three areas. This year, we will be the first company to offer clinical liquid biopsy products in all three of these significant markets, delivering on the audacious goal we set when we started Guardant Health. 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 signal that 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 applied the same technology framework to solve similarly long-standing challenges of 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. 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. 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 one clinical product on the market, Guardant360, the world's first and leading comprehensive liquid biopsy. What a difference 18 months have made. We now offer one of the most comprehensive portfolios in precision oncology with five clinical products now on 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.
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 a patient's response to therapy, including immunotherapies, a median of eight 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 time. 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, and by 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 relevant mutations in aggregated tissue biopsies can be blind to such changes. Now I'll detail some of our work in MRD, but 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 have poor performance. For example, CEA exhibits performance of 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 decade-old PCR-like methodology to detect a handful of hotspot mutations. The challenges to this approach are the long four-eight-week turnaround time 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 into clinical practice a little under a year ago, and it represents the first true liquid biopsy in the field whereby no prior tissue information or sample is 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 metastases 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. 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 is built on and the high sensitivity that epigenomics confers, allowing for hundreds of genomic and epigenomic regions to be affected on average per patient with detected recurrence. This contrasts with tissue-informed assays that, despite tracking dozens of mutations, may only detect 1-5 of those mutations on average. Finally, while tumor-informed tracking technologies are at their technological limits for 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 to go 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 for Reveal to over 70% of all solid tumors. ORACLE will 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 study and 100% specificity.
We are also seeing this excellent performance carry over 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 sensitivity 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- and tumor-informed approaches. Our oncology portfolio for existing cancer patients and survivors is now addressing over $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 the addition of our own tissue biopsy products. 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 can potentially only access less than half of this opportunity, given some of the logistical challenges with accessing tissue, especially in the surveillance setting many years out from the date of curative resection. 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 is 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, as 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. 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. What you know today as 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 100 times larger than Guardant360 CDx, provide even greater sensitivity, and includes 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 Amir Ali 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 cancerous signals at early stages with high performance. Our differentiated technology platform analyzes multimodal information in cell-free DNA. Building on top of our Guardant digital sequencing technology for genomic analysis, we've developed a novel integrated assay that can analyze epigenomic signals, including methylation and fragmentation changes in cell-free DNA. This multimodal analysis helps to achieve high sensitivity in detecting early-stage disease for diseases like CRC.
Now, digging into more details of our epigenomic technology. Unlike traditional bisulfite 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 with depletion step, removing residual non-methylated 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 assays used by many others. Now, our philosophy at Guardant for cancer screening. Our philosophy is to build products that will save lives. 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 test in guidelines. The offering needs to be in alignment with value-based care and the objective of health systems. Finally, we believe FDA approval is key to mainstream adoption of the test. As a result, we have focused on CRC as our anchor indication, and we will then add multi-cancer screening application to our install base. As a first step, we will expand from CRC to CRC and lung cancer screening, and then continue adding in many 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 the age of 45 years old. The benefit of screening has been limited due to the lack of compliance despite many efforts. The ease of use of blood tests holds great potential and promise for increasing compliance to screening tests. We have developed a highly sensitive assay for detection of early-stage CRC, and almost two years ago, we started our pivotal ECLIPSE study. Last month, we reached our target enrollment of about 13,000 patients. We expect ECLIPSE results in May 2022, this year.
We are on track to launch LDT version of this assay called Guardant360 within the next few months, and we 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 already established NCD. We also expect USPSTF grading and guideline inclusion in 2026. We are planning to gradually expand our commercial team to over 700 members throughout this timeline. 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 aimed at understanding adoption of the 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 advanced adenoma sensitivity in the current PCP market.
I'm confident about our strategy of starting with CRC screening as our anchor indication, unlocking the 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 eight control cohorts and confirmed similar performance in CRC relative to the current device that we have. 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 strides 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 offerings across the full 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 Guardant360 Response, TissueNext and Reveal assays, reimbursement wins for these new offerings, global expansion, especially in Japan, and new product launches of multi-cancer Reveal and our Smart Liquid Biopsy platform. On screening front, Shield LDT launch, FDA approval, CMS coverage and progress toward multi-cancer screening.
With that, I would like to thank you all for your time. At this time, I will turn it back over to Michael for Q&A. Michael.
All right. Thanks, guys. Before we jump into the, you know, business, I just wanna make sure you blessed revenues for the year. You said $360-$370. The Street said $365. Any commentary you're trying to make here on the fourth quarter, in terms of kind of where volumes ended up?
Maybe I'll jump in, Michael. No, nothing specific. I mean, that was our guidance from back at the last quarter. We're not sort of renouncing our numbers at the moment. But you know, we had a good strong quarter in the fourth quarter, so you know, we're good to still put those numbers out there.
Got it. On the clinical side, you know, CGP penetration is still low and in kind of the single digit range. Can you just talk a little bit about, you know, some of the drivers that are gonna be needed to accelerate that penetration? Do you need larger studies? Get in other cancers, you know, comparison of clinical outcomes, or is it just people waiting for more therapeutic options that come to market?
That's a great question. We see lung certainly as the avant-garde, kind of the, you know, the canary in the coal mine, so to speak. What we're seeing in lung today is that something like 40%-50% of lung cancer patients are getting some kind of NGS. Maybe it's not full CGP, but they're getting some kind of next-generation sequencing, maybe small panels at academic centers. We're really seeing that trend starting to accelerate. As you hit the nail on the head. What's different in lung cancer is 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, you know, 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. We think that bodes well for other cancer types really follow in the footsteps of lung cancer, where CGP is really required in a front line setting. We think it's a good setup for continued strong growth in many years to come. It's just a matter of time. It's a matter of changing physician habits. As you said, the multi-billion dollar investment that pharma is making today will pay dividends in the future for the need for this type of testing.
You had some international updates. We did get a couple questions on, you know, the U.K. and Japan. Can you just touch on, you know, how commendable those opportunities are? Does Japan have reimbursement coverage yet? Is that above U.S. rates? Are you just gonna be running G360 out of those international labs?
Yeah. 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, you know, Asia, Middle East and Africa.
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. The next step after that launch that's successful is really a public reimbursement. We're seeing reimbursement rates in Japan in the lower thousands of dollars, anywhere from $3,000 to $5,000. It's got a very large market opportunity, about 400,000 liquid biopsy indications compared to 700,000 in the U.S. 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 building two labs, one in Spain with Vall d'Hebron and other at the Royal Marsden in the U.K.
We ultimately think that public reimbursement is really the inflection point for material international revenue. We believe this strategy of building this global network of laboratories, of partnering with key academic centers is the fastest way to achieving that.
Maybe to touch on some of the recent launches. You know, Guardant360 Response, can you just touch on, you know, traction there? How's the attach rate to Guardant360? You know, how do you view it as being differentiated versus, you know, Signatera, for example, for response monitoring?
Yeah, no, I agree. As 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. You know, the nice thing is we can leverage, as we pointed out, you know, the significant volume we have with Guardant360 since it's an attachment rate that you know sits on top of Guardant360. We're seeing you know many physicians really kind of latch on. It really is the way that many physicians are already using you know Guardant360 informally. We have now really upped that with the Guardant360 Response. It's called solid tumors. 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.
You're really asking a full picture into a patient's disease in that metastatic setting, which is so important. You know, we couldn't be more thrilled.
Maybe a similar question for TissueNext. Since launch, you know, how much of that, you know, volume now is coming from existing, you know, current customers versus new customers who haven't used some of your products before?
Yeah. No, I mean, I think, you know, across the board we're seeing sort of equal traction in store sales versus kind of new physician adds. That's even with our legacy products with Guardant360, because there's a lot of growth, I think, still in the market. What we're certainly seeing with the TissueNext is that it's great. I think the thesis we had in launching this has started to bear out, which is it's getting those physicians that are uncomfortable 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, that tissue being run in the background. We're seeing you know, excellent numbers there.
I think we're seeing that we're cutting into a lot of the volumes that, you know, some of the competitive tissue CDx companies have out there because, you know, as we said in the presentation, we've gone from this single product to now this whole portfolio of products, dipodots. The beautiful thing about them is that they all work together in a very seamless way. Now, you know, physicians are, I think, more and more coming on to not just a single test, but a whole precision oncology platform that, you know, Guardant is providing to them.
In the future, you should get CMS coverage pretty quickly for TissueNext just given how established coverage is? I mean, do you expect it to happen here in the near term?
Yeah. It should be relatively straightforward. We're still, you know, in the process.
You know, maybe you could just talk a little bit more on the strategy around the Smart Liquid Biopsy. You know, will this replace Guardant360 and will you roll it out to Reveal screening? How do we think about, you know, the opportunity there?
Yeah. Right now it's only in the oncology kind of portfolio in terms of the Smart Liquid Biopsy. Yeah, the initial application is around that sort of 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 you know, we made the analogy to a smartphone versus a cellular phone. You know, I think a lot of people are using you know, whether it's TVs or cell phones and so on. Those are sort of commodity devices and those are devices that are very easy to commoditize. When you start thinking about you know, smartphones and what is the big leap there? It was going beyond just you know, a phone kind of technology.
It was adding GPS, it was adding all these other capabilities, whether it's, you know, email or, you know, wallets or cameras and so on. It wasn't the addition of that hardware in itself that really led to, you know, the huge utility of smartphones. It was how all of those products would work together. It was 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 seeing tons of capabilities. As we said, it's 100 times larger than Guardant360 CDx. That's only scratching the surface. There's capabilities around epigenomics, immune response monitoring and, you know, other applications and other capabilities and applications will fit on top of that in countless ways. Potentially drive differentiated clinical utility in those fields.
We're very excited about even just the initial crop of applications, but many, many more that we can't imagine today that are yet to come.
Is there a reason you're not gonna roll it out for screening, you know, given that you know, aren't running the assay yet for CRC?
I would say that there's a lot of technology that has, you know, been built for screening that's being incorporated into the Smart Liquid Biopsy platform. It's really the beauty of this is that we're taking that know-how, we're taking that sort of, you know, 10 years of pushing the limits of liquid biopsy towards, you know, very high sensitivity and early detection. We're applying a lot of that know-how to the Smart Liquid Biopsy platform. I think over time, you know, there may be convergence, but right now this is really designed for oncology.
Maybe for AmirAli Talasaz, just on a couple questions on screening then. You know, 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 in 2023?
In 2022 or in general, actually before FDA approval, we don't expect revenue to be any material, you know, contribution to our overall Guardant's revenue. 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 the test, we need to go through kind of payers and reimbursement. Since pre-FDA approval, we have very low expectation of getting some coverage policies. We think revenue contribution will be very minimal.
Got it. You know, ahead of the ECLIPSE readout, you know, the ACG data was 92% sensitivity. You know, any updated thoughts there in terms of, you know, where you might end up?
Across different early-stage cohorts, and especially early-stage asymptomatic, I'm excited with bunch of those data that we've seen. Typically we are seeing in different cohorts, different presentation like, you know, high 80s%, low 90s%. Going back to this market research that we've done, looks like the market sensitivity around those performance that we've done, mid-80s% for sensitivity is not much based on other promises of blood-based testing. We are really hoping that ECLIPSE would confirm the data in the ballpark of what we've seen so far in market research implied at this time.
Got it. Will we have data on, you know, beyond colorectal, this year? I mean, you touched on bladder, you know, liver, pancreatic. Will we have data on some of those as indications?
Yeah. 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. We have generated some data, and we plan to generate much more data.
Yep. Then maybe a question for Mike. It came in from investors. Would you start giving kind of volume breakouts for tissue for MRD, some Guardant360 for international? How do you think about the granularity you're gonna be giving going forward?
I think for the moment, you know, we'll just be reporting a clinical test number. You know, there's a lot of competitive information in there, breaking that out, and we're not seeing a lot of other companies break those out. You know, maybe in the future when it starts to become really meaningful and we wanna sort of, you know, explain what some of the dynamics of the business, but probably not for the foreseeable future.
Okay. You know, I guess there's a wave of newer, you know, companies coming on the screening side. Back to you, AmirAli Talasaz. You know, how do you think about competitive dynamics in this market? You know, is this a market that could be supported by, you know, half a dozen or more competitors on the screening side?
Definitely the TAM is large, but, you know, one thing I would like to emphasize is we believe we are gonna be the first company with just FDA approval and Medicare coverage for blood-based CRC screening and, you know, building on top of that other cancer types. This endeavor is not a few months, few quarters. It's few years, you know, starting from having a technology that really can offer a good performance in early-stage disease. With off-the-shelf technologies, if you use, you are not gonna get the performance we are talking about here. Then going through the clinical validation, ECLIPSE-like studies. This is a multi-year endeavor. I think the time gap between us and other people who are coming to this space is a matter of years, how I might put it.
Great. I know we ran a minute over, so I think we'll leave it at that. Good to see you all. Thanks for kicking off today.
Thank you.
Thank you. Take care.