All right. Good afternoon. Let's get started. I'm Julia Chen, lead analyst covering life science tools and diagnostics at JP Morgan, and it's my great pleasure to introduce you to our next company presentation by Guardant Health. With that, let me turn it over to Helmy.
Thank you, Julia, and thank you everyone for joining us and your interest in Guardant Health. Please note our forward-looking statement. I would like to start our presentation as we always do, with a patient story. These stories are the fuel that drives our relentless work and our mission to conquer cancer with data. Kirk Smith was an avid runner and cyclist, did not smoke, ate well, and was in great overall shape. Yet in December of 2013, Kirk was diagnosed with stage three lung cancer at just 51 years old. His oncologist ordered his first Guardant360 test in 2017, providing actionable insights that gave Kirk access to more targeted therapies as his cancer evolved. That was five years ago, and today he is a leading advocate for ALK-positive cancer patients worldwide.
I'm happy to say that Kirk is today a nine-year cancer survivor and flying high again, as you can see in this photo. To quote Kirk, "I believe this disease can no longer be a death sentence, but instead a manageable disease." At Guardant, we are committed to this precise transformation of cancer through earlier detection paired with earlier interventions. I'll present an overview of our business. 10 years ago, we set out to revolutionize how cancer is managed across the continuum of care. Long-standing challenges remained across three main areas of cancer care: therapy selection, recurrence monitoring, and screening. Today, we have developed breakthrough solutions for each one of these three areas and now are in various stages of capturing some of the largest market opportunities in diagnostics.
Nearly nine years ago, we launched Guardant360, the world's first comprehensive liquid biopsy that simplified therapy selection for 700,000 U.S. advanced cancer patients, eliminating the need for an invasive biopsy. We did the same thing again last year with Guardant Reveal, a blood test that is beginning to address the needs of 50 million cancer survivors with the ability to detect cancer recurrence earlier than a CT scan. This year, we broke new ground yet again and validated Shield, the world's first high-sensitivity blood test for early cancer detection through our pivotal 20,000 patient ECLIPSE trial. These three markets combined represent a greater than a $130 billion opportunity, and we believe we are in a prime leading position in each one. Looking ahead to 2023, we are excited about a number of initiatives we have laid out.
The first is extending our leadership position across the three areas I mentioned through our smart liquid biopsy platform. This platform will not only dramatically redefine what a liquid biopsy can do, but provide our business unprecedented operating leverage and economies of scale. Second, with the recent positive readout of ECLIPSE, we now expect to have the first Medicare reimbursed liquid biopsy for cancer screening, opening up what we believe to be one of the largest opportunities in diagnostics history. We'll begin to systematically reduce cash burn going forward to reach profitability in our oncology business in approximately 1-2 years, and in the overall business, 1-2 years after the USPSTF guidelines inclusion. Let's take a closer look at our oncology business.
With five clinical products in the market today, many of which represent first of their kind for our industry, Guardant has one of the most complete portfolios in precision oncology. Four out of five products listed here are covered by Medicare, with a fifth one expected this year. Our leadership position has been further fueled by our strong commercial channel, which we believe is second to none in the industry. This is borne out by market data that illustrates that we not only have by far the number one liquid, rated liquid biopsy, but the top-rated commercial field team, rated number one in oncologist satisfaction, a team that has nearly 50% more touch points with oncologists than our closest competitor. First, I will highlight our Guardant360 franchise, which includes Guardant360 liquid and tissue comprehensive genomic profiling products, as well as monitoring.
This franchise, propelled by our strong commercial channel and great products, continues to follow an exponential growth trajectory with 28% overall revenue growth year-over-year, now in its eighth year post-launch, and is approaching $400 million in testing revenue. The best part is that this is a market that still has plenty of room to grow, both on the clinical and biopharma sides. This growth will be fueled in 2023 and beyond by additional reimbursement for TissueNext and Response, our ongoing efforts at EMR integration, and obtaining reimbursement in Japan for Guardant360 CDx. Now shifting gears to Guardant Reveal. This is a franchise that is only in its second year post-launch and growing at record pace with 250% year-over-year growth in 2022.
This $20 billion market opportunity is less than 2% penetrated and is a market whereby half is only accessible by tissue-free liquid biopsy solutions, of which we are the only one on the market today. In 2023, we expect to see continued rapid growth in key tumor types, continue to collect data for reimbursement and additional indications, and most excitedly, we are still at the very beginning of the technology performance S-curve for Reveal, which we will speak to shortly. Last year, I teased this concept of the smart liquid biopsy, what we believe to be a quantum leap forward for the field. We all know that the critical inflection point for the smartphone was when mobile computing became powerful enough to drive profound new applications wirelessly.
I'm happy to say that this is exactly the inflection point we have unlocked with our smart liquid biopsy platform, which we believe will drive the next chapter of growth for our oncology business. Why do we believe that our smart liquid biopsy platform has reached this critical inflection point today? The reason is we have combined two powerful technological advancements in precisely the same way as a smartphone. Specifically, we take the power of liquid biopsy with all its advantages, simplicity, independence of specific tissue site, its capture of a sum of everything that is going on in the body, and its ability to monitor temporal dynamics with additional blood draws. This is analogous to the convenience of mobility for the smartphone.
The major breakthrough, though, is that combining this with a revolutionary new multimodal chemistry allows us to see both genomics and epigenomics simultaneously with ultra-high sensitivity and specificity across a large swath of the whole genome. This platform does not compromise an underlying performance, but actually improves it dramatically, delivering 100 times the genomic breadth and over 50 times better sensitivity than Guardant360 CDx at the same cost of goods. To put that in perspective, this is an effective 5,000x reduction in the cost of data acquisition versus the chemistry used for Guardant360 today. Let me take a minute to explain why we believe the addition of broad epigenomics to our platform is so exciting. There are 37.2 trillion cells in the human body.
They all share one genome. That is, they all have the same 6 billion letters. Once you've seen one cell, you've seen them all. Genomics is blind to what our own eyes can see. There is clearly enormous diversity between the cells in our own body, eye cells, liver cells, skin cells, that all look and behave completely differently, yet are identical under a genomic-only lens. No wonder genomics has frankly been underwhelming in the study of diseases outside of cancer, infections, and rare genetics. Indeed, in the mission to cure illness, genomics has been largely overrated. This is not to say that genomics isn't important. Since the advent of the Human Genome Project, we've been collectively brainwashed to think that genomics is the be-all and end-all for understanding human disease when the critical missing piece of the puzzle has been right under our noses.
Epigenomics is that missing piece. Through an epigenomic lens, the cells in our body look completely different. Almost every disease imaginable has a robust fingerprint in the epigenomic domain, from cancer to cardiovascular disease to neurodegenerative disease. Obesity, depression, and even gambling addiction can cause changes to our epigenome. Yet we have been collectively blind to this due to the lack of tools to broadly characterize the epigenome. This is what makes our smart liquid biopsy platform so powerful. For the first time, we can capture the secrets of the epigenome at high sensitivity across the whole body with a simple blood draw at scale. Let's illustrate the power of the epigenome for cancer, a disease that we often refer to as a disease of the genome. We see that a genomics-only lens shows us a small part of the picture.
The same picture of cancer under a broad epigenomic lens reveals 10 times more information and much more functionality. You are well aware, the first application we launched out of our smart liquid biopsy platform was our screening test Shield, which uses many of these epigenomic signatures to detect cancer and blood at much higher sensitivity than ever before. Detection of early-stage cancer is just scratching the surface of what this platform can do. The second assay we launched from this new platform is Guardant Infinity, which we believe to be a major step forward for liquid biopsy. Let me show you why. This is the same sample analyzed with both Guardant360 CDx and with Guardant Infinity.
As you can see, Infinity provides 100 times the data, providing a detailed view of tissue of origin, genomic alterations, promoter methylation, complex HRD and immuno-oncology signatures, just to name a few. This compares to Guardant360 on the left that can detect just a handful of data points with its more narrow and genomics-only view. The 100 times breadth of Infinity does not compromise its sensitivity. In fact, our smart liquid biopsy platform chemistry improves it significantly by over 50 times, enabling detection of tumor fractions approaching 1 part in 100,000 and as low as 1 part in 1 million. I'm happy to announce that the first clinical oncology assay that will be upgraded to our smart liquid biopsy platform is Guardant Reveal.
For MRD assays, performance is predicated on how many tumor biomarkers, whether mutations or epigenomic markers, one can detect per blood sample. The more biomarkers, the higher the sensitivity, since one has more shots on goal to detect the cancer. Whole exome tumor-informed approaches detect fewer than 50 features per patient, and some detect as few as 16. What is truly exciting is that when Guardant Reveal is upgraded to our smart liquid biopsy platform, we'll see a massive sensitivity boost of over 5x as we go from detecting less than 50 biomarkers to over 1,000 per patient with even higher specificity. All without the need for tissue. We are looking forward to this upgrade, which will supercharge our Guardant Reveal assay later this year.
Finally, our smart liquid biopsy platform is not just revolutionary from a scientific point of view, but gives Guardant very strong operating leverage in our business. The merging of all of our clinical oncology products onto our smart liquid biopsy platform, starting this year with the Reveal and extending to other products over time, will enable rapid deployment of performance improvements and applications from one product to another, and operational efficiency whereby we can leverage, for example, screening infrastructure investments across the entire portfolio, enabling very low COGS, not just for screening, but for all of our products, as well as industry-leading turnaround time. We believe that this is a key component that will accelerate our path to profitability. Now I'll turn the call over to Amir Ali to give an overview of our work in screening.
Okay. Thank you, Helmy. excited to talk about the screening activities that we have. Last month, we're pleased to share positive results from our pivotal ECLIPSE trial. ECLIPSE is an over 20,000 patient prospective study at registrational grade to evaluate performance of our blood test in detecting CRC compared to colonoscopy in average-risk adults. When recruiting for ECLIPSE, we are very deliberate and thoughtful in our approach to achieve a diverse study population representative of the real people in U.S. population. We are proud that the enrollment among minorities were above average for a clinical trial, which is important given the disproportionate impact of CRC. Running ECLIPSE also generated a treasure of biobank samples from intended use population for future development purposes. In the ECLIPSE trial, our test demonstrated 83% sensitivity in detecting individuals with CRC with 90% specificity.
These results exceed the performance criteria set forth by CMS to qualify for reimbursement established by National Coverage Determination for blood-based CRC test published by CMS in 2021. In comparison, the sensitivity of FIT test, the most utilized test for CRC screening, is 74%. The sensitivity of our test in Black population cohort was 90%, higher than 62% observed by Cologuard stool test, highlighting the importance of characterizing the test performance in diverse populations. Advanced adenoma sensitivity was 13%. Adenoma detection is helpful in cancer prevention, fewer than 5% of adenomas are ever getting progressed to invasive cancer. Getting to this study readout was momentous, not just for Guardant, but for the whole screening community. We are thrilled with the overwhelmingly positive feedback we got post ECLIPSE readout from thought leaders and patient advocates.
The leaders who understand the unmet need, ease and preference of blood testing over stool, the importance of adherence in completing a test, they see blood testing modality as a disruptor, believe the observed sensitivity was above the bar, and they see the beginning of a new era in the cancer screening field. Now, with this result from our trial in partnership with supportive thought leaders and influencer, we will make access to blood-based CRC screening a reality. Now, let's talk about some of the main barriers to colorectal cancer screening in the United States. Successful screening test requires both adherence and performance in detecting cancer. Although the performance of gold standard colonoscopy test is satisfactory, a recent large study revealed that just 42% of individuals completed an ordered test. This low adherence to colonoscopy has generated opportunities for non-invasive stool-based tests.
The adherence to stool-based testing, like FIT and Cologuard, is around 43%-65% and has been stagnant for many years. With all of these screening modalities, we estimate about 49 million people out of 120 million guideline-eligible individuals remain unscreened. When it comes to breaking this barrier in screening, the best test is the test that gets completed. Based on survey results, 7 out of 10 patients who completed stool tests previously prefer not to choose this method again. On the other side, in our experience, more than 90% of individuals completed their blood screening test in the first 10,000 ordered Shield test, our lab developed CRC screening. The high performance of our blood-based CRC screening test with 90% adherence is the solution here. As I mentioned, successful screening test requires both adherence and performance.
The effectiveness of a screening test is impacted by both clinical sensitivity and adherence. As shown in this table, the effective sensitivity of our Shield test in detecting cancer is higher than all other modalities of CRC screening. For each 1 million individuals intended to be screened, Shield detects 30,000 CRCs versus 13,000-24,000 CRCs detected by other methods. We believe this increased CRC detection is potentially one of the biggest breakthroughs in the field of oncology. With our successful readout of ECLIPSE, we are on a path to potentially deliver the first FDA-approved and reimbursed multi-cancer screening test. For CRC detection indication, we expect to complete our PMA submission for FDA approval in the Q1 of 2023, and anticipate FDA approval and launch of Shield IVD in 2024.
FDA approval will pave the path for Shield to be the first Medicare-reimbursed blood-based CRC screening. The next steps will be getting into ACS guidelines in parallel to getting an advanced diagnostic lab test or ADLT status, and establishing the favorable ADLT pricing. Inclusion and updated USPSTF guidelines will drive private payer reimbursement with no out-of-pocket payment for all. For the lung indication, we will complete the enrollment on our registration of Shield Lung by 2025, and potentially submit for FDA approval in the following year. We are expecting and excited to get data readout from another prospective lung cancer study, NCIRE-LUNG, later this year or by mid-2024. We are also working on adding a large panel of other cancer indication into the same Shield test.
We have shown data in case control cohorts in several cancers, and we'll announce our multi-cancer clinical study in the future. Speaking about lung cancer, lung cancer is the leading cause of cancer-related death in the United States. Symptoms of this cancer typically don't appear until the disease is already at an advanced stage. However, the screening compliance study demonstrate gross underutilization as only around 14% of people eligible for a screening are up to date with screening recommendations using low-dose CT scan. We believe a simple blood test has the ability to both offer a high rate of test adherence by individuals and also detect the majority of lung cancer cases in early stages. Earlier, we have announced our SHIELD Lung study.
SHIELD Lung is designed to provide registrational-grade evidence for the accuracy of our assay in individuals who undergo standard of care screening using low-dose CT. We are targeting enrollment of nearly 10,000 individuals. Now we are announcing another prospective lung study, NCIRE-LUNG. This study, in fact, started enrollment back in 2017 at San Francisco VA and UCSF, targeting the readout of the performance of Shield test. 600 individuals who are at high risk of lung cancer based on screening protocols or based on incidental finding of lung lesions are getting enrolled and monitored. We expect the readout of these studies sometime later this year or by mid next year. Although CRC and lung are the initial and strategic indications for Shield, they are not the only indications.
Shield multi-cancer screening test, powered by our Smart Liquid Biopsy platform, can detect many cancers in the same blood sample. Sequencing data generated from a single assay will be sufficient for detection of signatures from multiple cancer types using algorithmic upgrades. CRC indication will open up the screening market for Shield with a a three-year interval testing, and over time and with indication expansion, we expect the testing frequency to increase to annual testing. We believe blood-based screening will be transformational and will contribute significantly in reducing overall cancer mortality to less than 50% within the next two decades. In summary, we are excited about the opportunities for Shield CRC screening test with the potential testing volume of approximately 10 million annual tests sold in 2032 and growing, with a brand value of over $5 billion in that year.
We have a roadmap to achieve more than 60% gross margins at scale. Talking about our financials. This morning, we shared our preliminary full year 2022 revenue and testing volumes. We are very pleased with the strong finish to 2022, with revenues in the range of $447 million-$450 million, which is at the upper end of our revised guidance range and growing 20% over the prior year, driven by over 40% full year volume growth in both our clinical and our biopharma businesses. This strong finish to year gives us good momentum starting off in 2023 to be able to show continued consistent revenue growth. We are also focused on cash management and capital deployment for the next few years, both in terms of phasing and allocation.
We finished the year with $1 billion in cash on the balance sheet, reflecting about $400 million cash burn for 2022. This was our peak year in terms of cash burn as we completed significant investments to establish what we believe is the strongest platform in oncology diagnostics. With our core infrastructure now firmly established, we can start to gain material leverage from it. As we continue to grow revenue in precision oncology this year, the additional gross profit we expect to generate together with our close management of operating expenses, will reduce our cash burn by about $50 million compared to 2022.
We forecast this trend and additional leverage to continue into 2024 and 2025, which means we expect to continue to reduce cash burn and can maximize our cash runway beyond 3 years from now. We also wanted to provide some insight into our thoughts on resource allocation over the next 3 years. The pie chart provides rough breakdowns of projected investment by business line to fund growth and maximize the vast market opportunities in front of us. Starting with therapy selection at core, while we will continue to aggressively target Guardant360 revenue growth, both in the U.S. and abroad, the business is essentially self-funded over the next 3 years, and we are on track to break even in about 12 months' time. Moving to recurrence monitoring, this is one of the most exciting growth opportunities in diagnostics. We are among the first movers.
We have significant clinical data development in progress. We are set for a step change with smart liquid biopsy platform. Reveal will leverage our existing oncology commercial operation and will provide material revenue growth over the longer term as we achieve further reimbursement coverage. Our most significant commitment is screening, probably the largest opportunity in diagnostics. We split our funding of screening into two buckets, pre- and post-FDA approval activities. Prior to FDA approval, we will continue with select market development activities as well as continue technical and data development for lung and other cancers, while reserving the necessary resources to fund a strong commercial launch in CRC following FDA approval. Our long-term vision is to transform cancer diagnostic through cutting-edge technology, a focus on high-impact opportunities, and consistent execution. We delivered great progress in 2022. 2023 is set to be another exciting year. Thank you for your interest in Guardant, and with that, we'll turn it back to Julia for Q&A.
Thank you, AmirAli, and thank you, Helmy, for a great overview. As a reminder for the audience, if you have a question, feel free to raise your hand. We'll get a mic to you. You can also submit your question through the digital conference book. Maybe to get us started, congrats on strong 4Q pre-announcement. Any color you can share regarding, you know, what really drove the strength here, any surprises to the upside and what supports your latest outlook for 2023?
Yeah, no, I mean, we're very excited by the volume growth we saw in Q4. It was really broad-based. We saw both Guardant360 volume grow really nicely and then, obviously, we continue to see pretty tremendous growth with Guardant Reveal. You know, I think it was just about sort of resetting that baseline in terms of where we were post-COVID. Now that we have this baseline of about 70%, 75% office access, we believe that, you know, going forward, we're gonna continue to see this very nice growth in really all segments of our business.
Great. In terms of smart liquid biopsy, obviously very exciting announcement. I'm sure you're very excited about the potential there. How should we think about timing, you know, first half versus second half, and then what is the regulatory pathway from here?
These are our LDT products, it's a pretty kind of simple upgrade in terms of these products. Guardant Reveal will be the first one, which will happen sometime this year, probably mid this year. We'll continue with the other products in our portfolio. Really excited about the consolidation this gives us and the leverage this gives us across our entire portfolio, 'cause it's a unified technology base, unified operational base, and it's really a kind of leverage that few companies have seen in this industry.
In terms of the market opportunity this unlocks, I think, you know, we've seen that, you know, so far, right, MRD market has been more dominated by a tumor-informed approach. With the 5-fold improvement in sensitivity for, you know, smart liquid biopsy, how do you think that allows you to compete more effectively with a tumor-informed approach? Yeah, how to think about the reception there?
Well, there's no competition. It's apples to oranges. I mean, you essentially have one approach that's not a liquid biopsy, requires tissue, and another approach that truly is, which is Guardant Reveal. Yeah, we really do believe that we're in a league of our own, and this sensitivity improvement, performance improvement, the smart liquid biopsy capabilities, we believe this is opening up a chapter that is very similar to what we did in 2014 when we launched the first comprehensive liquid biopsy. It's really a whole new era for what liquid biopsy can do, and MRD is just the beginning.
Gotcha. In terms of the reimbursement kind of, you know, pathway, you know, recently just received a CMS coverage for, you know, the current version of Guardant Reveal. With smart liquid biopsy upgrade, like, what does that entail in terms of new studies you need to run or new processes you need to go through?
This is not something that, you know, we just put together, you know, this year or last year. This is something we've been thinking about, you know, for a while. Obviously, we first teased smart liquid biopsy last year, yeah, this is, you know, it's an intricate sort of upgrade because it involves multiple lines of our business, involves reimbursement, involves, you know, multiple aspects. It's something we've mapped out really well, and we're very confident that transition can go very smoothly.
Gotcha. In terms of the volume uptake for, you know, Reveal, any color you can share regarding, you know, what kind of, you know, volume level you're currently doing and where can that go in the relatively near-term horizon with smart liquid biopsy?
Yeah. We're not breaking it out, you know, just yet, but obviously we mentioned the very strong year-over-year growth, 250%. I can tell you that when we expanded from colorectal to colorectal, breast and lung, we saw essentially acceleration in volume in the second half of 2022. Not just because of the addition of breast and lung, but actually the volume pickup of CRC picked up as well, accelerated. We're really pleased where we are in terms of, you know, our Reveal volumes. I think it's just a matter of, you know, essentially getting the data, getting additional indications, and really building up that same ramp we had with 360. You saw that, you know, 8-year roadmap of Guardant360, and we think, we're sort of in the early innings of what that looks like, but one that could be even much stronger.
Great. I'm gonna have a lot of questions on Shield and put AmirAli in the spotlight now. Before I do that, any questions from the audience regarding... Yes. The mic is coming to you.
Can you talk about some of the drivers behind the volume pickup in colorectal? Is it just beginning of a new growth trend after baseline?
Sorry, could you repeat the last part?
On the colorectal test volumes.
Yeah, no, I mean, we have always seen very strong fundamentals to our business throughout the years. I think what you're just seeing is essentially, you know, us continuing to execute. I mean, I think there were a few things that happened in previous, you know, quarters in terms of expectations being kind of off in terms of where the snapback would be because of COVID. You know, initially, we had said that, you know, volume growth would be 50% and ended up being 42%. It was just, you know, proper calibration given this COVID environment. Now that we've taken this new baseline, we think, you know, we're gonna continue to see this kind of growth going forward, so. If anything, we couldn't be more thrilled where things are.
All right, moving on to Shield. Congrats again on the recent ECLIPSE readout. In 3Q, you gave some strong update on the initial volume uptake of Shield LDT. Curious, you know, how you've been Shield volume trending in 4Q, you know, before and after the ECLIPSE readout, and what's been some early feedback from physicians regarding the readout results.
The feedback from actually the target physician that we have given at them access to Shield is very strong. Like, you know, just the promise of this adherence that the patients are completing screening tests. This is something that not we are talking about, that this is an unmet need and unsolved problem for them. They're excited that the blood draw testing is getting done, report is going to them. In terms of the volume trends, like when we launched Shield LDT, we really have this kind of a goal of market shaping and doing some kind of market development to be ready for FDA approval, approved launch of the Shield. We are not spending actually a lot of resources or thinking about how to further increase the LDT volume at the time that we don't have any ASP, frankly. Thinking about it more strategically of what we need to do, like, in 2023 to really have a strong post-FDA launch, and that's our main focus.
Speaking of FDA, seems like you're on track to submit by Q1 . Assuming that, you know, you'll include all stage-specific performance information in your submission dossier, I mean, will we, you know, can we expect any, you know, press release or, you know, presentation at a medical conference before publication of the full result?
Actually, when we are gonna have our publication, definitely all these details would be included. You know, still we are at a stage that about one-third of the CRCs are unstaged. Like the two-third which are staged, actually, when we just look at the sensitivity of those two-third, in fact, the sensitivity is even few notch higher. In fact, it's kind of confusing. We need to just wait for the unknown stage to get staged and see where the non-detected ones are getting distributed to have a better sense. Frankly, like for colorectal cancer, where stage one all the way to three is curable with different kind of a degrees of like, you know, high sixties, low seventy, all the way to like kind of high eighties, all of these are relevant kind of finding. We know based on what we've seen so far and some of the indications that, you know, this is not a study which, you know, is heavily biased by stage 4. It's not the case. We just need to figure out where the samples are gonna fall between stage 1, 2, 3 at the end of the day readout.
Any sense of the number of cases that are still kind of, you know, pending the staging confirmation at this time?
About one-third. Out of 65, about one-third.
Okay. Gotcha. Have you had any preliminary, you know, discussions with the FDA? Any, you know, preliminary feedback?
We are actually under review with FDA on our earlier modules. We talked about we are doing modular submission with FDA. In fact, I'm pleased that, you know, a couple of our modules almost, you know, I think all of our modules now is completely closed in terms of review cycle with FDA and back and forth and adjustment.
Yeah.
Additional documentation that they wanted, from us. We are just, you know, this just data module is pending, and that's our last module. The rest so far has been great.
Okay. What's your thinking on the probability and the potential timing of the FDA, you know, convening an extra expert panel to review the approval? If so, you know, what can be the moving pieces? I think, you know, pretty much we know the FDA approval of the test is de-risked. Is AA inclusion in the label the main, you know, variable here, and how meaningful is that piece?
Like, I think maybe starting from the back end. In terms of label, like, you know, we are seeing a CRC sensitivity of 83% with 90% specificity, and most utilized test for CRC screening still is FIT with 74% sensitivity. By just connecting the dots, you know, definitely we have a very strong argument that this would be like a first-line CRC screening. Advanced adenoma, we have to, you know, see what's gonna happen. Frankly, we just need that CRC label indication to make sure we have a good label there. Advanced adenoma, as we talked about, is mainly about prevention. In terms of panel discussion, it's in FDA's like, you know, decision if they wanna call panel or not. We talked about that.
Even for Guardant360, our experience with agency was they didn't call the panel, but they talked to a few of our KOLs and customers that we had for Guardant360. Now if they call for a formal panel or not, we have to see. Now they have more experience than the time that they reviewed Cologuard as the first stool test that they reviewed. They have more experience than the time that Epi proColon got reviewed. Frankly, like, you know, that was a study with borderline or actually failed kind of a submission in terms of clinical validation and a low specificity that got approval based on, you know, promise of adherence. I think the nature of this data readout is different, but we have to see what FDA wanna do when we go through data review with them.
Any last questions from the audience? All right. We can wrap it up there and give everybody extra minutes to get to the next meeting. Thank you, everyone.
Thank you.