Morning and welcome to the Lucid Diagnostics Investor Conference Call. At this time, all lines are in a listen-only mode. Following the presentation, we will conduct a question and answer session. If at any time during this call you require immediate assistance, please press the star zero for the operator. Please note this event is being recorded. I would now like to turn the conference over to Matt Riley, Lucid Diagnostics Senior Director of Investor Relations. Please go ahead.
Thank you, Operator, and good morning, everyone. Thank you for participating in today's conference call. Joining me today on the call is Dr. Lishan Aklog, Chairman and Chief Executive Officer of Lucid Diagnostics. Before we begin, please note that today's call will include forward-looking statements. These statements are based on our current expectations and assumptions and involve risks and uncertainties that could cause actual outcomes to differ materially. Today's remarks may include commentary regarding, among other things, the September 4 Contractor Advisory Committee meeting convened by MolDX- participating Medicare Administrative Contractors, the reconsideration of Local Coverage Determination L39256 for EsoGuard, our reimbursement and market access strategy, potential regulatory and operational milestones, and other matters related to our business and future performance. CAC meetings are advisory in nature and do not establish coverage determinations.
Important factors that could cause actual results to differ are described in our filings with the SEC, including Part 1, Item 1A, Risk Factors, and our most recent annual report on Form 10-K, as updated by subsequent quarterly reports on Form 10-Q, and current reports on Form 8-K. We encourage you to review these disclosures carefully. Except as required by law, we disclaim any intention or obligation to update or revise any forward-looking statements made on this call, whether as a result of new information, future events, or otherwise. I would now like to turn the call over to Dr. Lishan Aklog, CEO of Lucid Diagnostics. Take it away, Lishan.
Thank you, Matt, and good morning, everyone. I appreciate you all joining us today. As Matt said, we thought it would be helpful to hold an update call to discuss last week's MolDX CAC meeting in some detail. If you are one of the over 200 individuals who listened to the meeting, it should be no surprise that there's broad agreement that it was an overwhelmingly positive meeting. Although going in, we were highly confident. We really believe in our data, and we knew that there was broad clinician support for EsoGuard. It really far exceeded our own expectations. I participated in or witnessed many such panels over the years, and I'd be hard pressed to say it could have gone any better.
I think the 11 medical experts who participated in the meeting really expressed unanimous agreement on a variety of key matters: the urgent unmet clinical need, the strong body of clinical evidence supporting EsoGuard, and really explicitly said that Medicare should cover it so they can offer it to their patients to detect precancer, and that this was all consistent with established guidance. They really positioned EsoGuard as the missing link that many of them have been waiting for, literally for decades, after they had already established this paradigm for preventing esophageal cancer through the early detection of precancer. Dr.
Mike Smith, who's the Associate Assistant Chief of Gastroenterology at Mount Sinai and the incoming President of the American Foregut Society, one of the leading societies focused on esophageal disease, really summarized his sentiment quite well when he stated that EsoGuard is a no-brainer, that it represents best practice, and it had a remarkably high benefit-to-risk ratio. Before we dive into the highlights of the discussion, let's spend a few minutes on the purpose of the meeting itself. I spent a lot of time during last month's running call on the entire LCD process and the history leading up to the CAC meeting, and I certainly won't repeat all that.
Just briefly, MolDX has published a final Local Coverage Determination in 2023 that clearly outlined coverage criteria for tests such as EsoGuard, but it was non-covered at that time since we didn't have sufficient data at that time to warrant coverage. As you may know, we submitted a request for reconsideration of this Local Coverage Determination, this LCD, and our complete, what was now our complete evidence package in late 2024. This reconsideration and clinical evidence package was reviewed during the first half of this year, and the MolDX participating Medicare contractors, the MACs, called this CAC meeting, Contractor Advisory Committee meeting, as what we believe is really the final stage in the process of proceeding to a coverage of EsoGuard. The Director of the MolDX program, he chose to chair this meeting himself, clearly explained the purpose of the meeting from the onset.
He noted that the only things that can inform their review of the LCD process, their writing of policy in this context, is peer-reviewed published literature and the proceeds, the information offered by medical experts during one of these public CAC meetings, the public meeting that's part of the public record. He explicitly stated that the goal of the meeting was to have these experts provide primarily clinical context on the public record to supplement the peer-reviewed published literature. It's also critical to note, as he did, that the meeting was not simply put forth by the MAC that he's the Chief Medical Officer of, Palmetto GBA, but it brought all of the MolDX participating MACs together, including Meridian, which is the MAC that has oversight over our laboratory in Orange County, California. Let me talk a little bit about why that's important that all the MACs were there.
The MolDX program effectively operates by consensus. Even though the MolDX group that is housed within the Palmetto GBA MAC does the heavy lifting with regard to the analysis and much of the writing of the coverage determinations, historically, all four of the, now four of the MolDX participating MACs all typically put out identical local coverage determinations. It's important at the tail end of this process, after the MolDX group has done its work, that all of the MACs come together to achieve a consensus with regard to issuing a coverage determination. That's why it was important that this was, as noted, it was a multi-jurisdictional CAC meeting. The panelists were all invited medical experts. They were a carefully selected group of eight physicians, and they covered a broad spectrum of specialties as well as practice venues, the type of practice that they operate under.
If you let's just go through them a little bit real quickly. If you look at the academic gastroenterologists on the list, I mean, it's literally a who's who of international experts in the field and leaders, particularly in the areas of esophageal, precancer, and cancer. This included three physicians who have been instrumental in the authoring of guidelines in the area of esophageal precancer testing. Dr. Nicholas Shaheen is an internationally renowned expert in this field from the University of North Carolina, and he's the co-author of the American College of Gastroenterology, or the ACG guidelines, which are really at the heart of, sort of at the center of how we view the target population of patients who should be tested. It also is the guidelines that were included within the criteria of the LCD verbatim, as well as in other criteria such as the NCCN criteria.
Other co-authors of guidelines included Dr. Prasad Iyer, who is a Professor and a Division Chief at Mayo Clinic, Dr. Shada Rouhani, also a Professor of Medicine at the University of Colorado. They are both co-authors on, and Dr. Rouhani was the lead author on the American Gastroenterological Association. Also included other gastroenterology leaders in the field. Dr. Michael Smith, who's Associate Assistant Chief of GI at Mount Sinai, is the incoming President of the American Foregut Society. The American Foregut Society is the leading society that brings surgeons and gastroenterologists together who are entirely focused on the diseases of the esophagus. That society, AFS, has been very instrumental and supportive, as Dr. Smith mentioned during his comments, in pushing payers, including commercial payers, to provide coverage based on their own experience with it. Dr.
Amitabh Chak from Case Western, also a Professor there, is the current President of the ASGE, the American Society for Gastrointestinal Endoscopy. Literally a who's who of academic gastroenterology. I forgot to mention Dr. Steve Meltzer from Johns Hopkins participated as well. The group was supplemented by two pathologists, Dr. John Booth from Washington University in St. Louis and Dr. Elizabeth Gibson from Yale, and a surgeon, a GI surgeon, foregut surgeon, Dr. Christy Dunst, who offered, she's the next President of the American Foregut Society. She's at Hoag Digestive Health Institute, and she's playing a central role in the Hoag Health System of bringing in EsoGuard as part of a comprehensive program across hundreds of primary care physicians within that group. Last but certainly not least is Dr.
Jamie Glover, the Primary Care Physician based in Colorado, who was a very potent advocate from a primary care point of view of endoscopic, non-endoscopic screening in general, as well as the EsoGuard test. Dr. Paul Panzarella also played an extremely important role. He was a private practice gastroenterologist in Orlando. That was the panel. 11 folks. We were actually quite pleasantly surprised that they were able to get through two hours and 17 questions with that many panelists, but the moderator did an excellent job. It was really, by every measure, a very substantive two-hour discussion. Let's talk a little bit about what they discussed. Before going into sort of specific commentary, we should, just as a reminder, there are two main categories of data that's used as part of an evaluation of a test such as EsoGuard. Those are clinical validity and clinical utility.
Clinical validity is the intrinsic performance. Does the test work? Does it find these precancerous conditions, and does it find cancer with a high level of accuracy? That certainly was a central part of the conversation. The number, if you listen to the call, that came up repeatedly was EsoGuard's 99% negative predictive value. Multiple physicians highlighted that number as a key determinant of why EsoGuard is a reliable rule-out test. This was an extensive discussion on how reliable is EsoGuard as a rule-out test. The focus here was that if you have a negative test, if you, the physicians who are participating here, have a negative test, can you feel confident that nothing further needs to be done in that patient, that you've ruled out the serious conditions of esophageal precancer and cancer?
There clearly was, I won't go through all the quotes from the meeting, but there was clearly a strong consensus that that was the case. I think Dr. Smith, again, summarized it pretty succinctly. He said the tests are negative, you're done. That's a really important, you know, the first step in the assessment of the data is demonstrating that this test, which is designed, as those of you who listened heard, as a rule-out test. The test was developed to have maximal negative predictive value, maximal sensitivity, and it certainly performs in that regard. There was a full consensus that that was the case. There was also, similarly, a discussion on the rule-out nature of this. It was important to clarify that EsoGuard is a rule-in test. It's not a rule-out test.
It's designed to rule out serious disease in the vast majority of patients who are within this well-defined group of patients of approximately 30 million patients who have these risk factors and have symptomatic heartburn, and that it does so, it avoids the need for endoscopy in the vast majority of those patients. The rule-out test is the endoscopy itself. There was a good amount of discussion that the EsoGuard enhances the rule-out test by increasing the yield of the endoscopy two to three-fold. Any questions around whether we were ruling things out with EsoGuard or how EsoGuard fit within this rule-in and rule-out paradigm was very clearly outlined, and it was an area of significant discussion that went over to strong consensus on that. Related to that was a very important consideration when one evaluates the accuracy and the evidence around diagnostic tests.
That is, what is the risk of a false negative, and what's the risk of a false positive? That's not always the same for tests that may have the same accuracy. What you do, what the situation, what risk the patient is exposed to if they have a false negative or false positive is not the same. If you had a chance to listen, they went into that in some detail. Let's first start on the false positives. If you have a patient who has a positive EsoGuard test, and they are sent for an endoscopy, and they have a false positive, that patient was not exposed to any additional risk because they are getting a test that they otherwise would have received. There's no incremental risk to that. The physicians clearly stated that repeatedly, especially the gastroenterologists outlined that.
That's different than other tests, for example, tests to screen for lung cancer or tests to screen multi-cancer detection tests for blood, where a false positive can lead to invasive procedures that otherwise would not have been performed, biopsies and other head-to-toe kind of scans that can lead to risk to the patients. It also was highlighted that here we are detecting primarily precancer. A false positive test doesn't trigger the same type of anxiety that potentially can in tests that are primarily focused on cancer. The whole question of the risk of a false positive and the essentially zero, well, extremely low or zero risk of a false positive, given that endoscopy is safe even if it is invasive, was very well established by the panel. The same is true about the risk of a false negative.
If you have a test that's primarily focused on detecting cancer and you miss one, that carries significant risk, especially if your test is an alternative to a test that the patient would otherwise have received. As the panelists described and with a lot of clarity, that is not the case with EsoGuard. These are typically patients who would not have undergone any testing, so a false negative is, even though the false negative, the likelihood of a false negative is only 1% or so. That is a low-risk false negative because, A, the patient wouldn't have received the test anyway, so there's no incremental risk to having had this test. Most importantly, the fact is that essentially all of those patients are going to be precancerous patients. The likelihood of missing a cancer, first of all, EsoGuard has to date not missed a cancer, a 100% sensitivity there.
The likelihood of missing a cancer in that 1%, the likelihood that that 1% would be a cancer is vanishingly low, and they outlined that quite clearly. Another area within the clinical validity data that was part of a question that was brought up, and we think importantly brought up by MolDX, was around the ability of the test, the accuracy of the test across the spectrum of conditions that we're looking for. This relates to the issue of short segment versus long segment Barrett’s esophagus, and that was a central part of the discussion. The highlight there is that EsoGuard performs equally across the spectrum.
It has a high sensitivity and negative predictive value for cancer, for the later stage precancers, dysplasia, for early stage precancer, so-called Barrett’s esophagus, nondysplastic Barrett’s esophagus or metaplasia, and even in those patients who have just a small patch of abnormality, as little as one centimeter, so-called short-segment Barrett’s esophagus. Various physicians, Dr. Shaheen and Dr. Smith, both highlighted that that is in fact critical. Shaheen pointed out that the vast majority of the disease of the patients that we're trying to find and put into surveillance so we can detect the later stage precancers and treat them before they develop cancer, that the vast majority of that disease is in fact short-segment disease. Dr.
Smith followed up with some statistics on that, which is that up to 70% of the target population that you're trying to identify has short-segment disease, and that 50% of the cancers have short-segment patch, 50% of the cancers arose in a patch of disease that would qualify as short-segment disease. What was clearly established during this meeting by the experts is that a test to be appropriate for use and to have sufficient clinical validity here has to have excellent performance across the spectrum from short-segment disease all the way to cancer. There was a strong consensus that EsoGuard does in fact have that. That's clinical validity. Actually, in some ways, that's the more straightforward part because that's very much just baked into the data. That is, it was an opportunity for these expert clinicians to highlight the areas there.
Frankly, the area of the data category that was really most important to discuss during this meeting was the other bucket, the clinical utility data. The reason for that is that, unlike a study for a drug or some other studies where all of the data is essentially included in one big, big sort of hairy randomized clinical trial, a lot of the evidence in these kinds of tests represents sort of a chain of evidence around the utility of the test. How does the test perform in a real-world use? What utility is it offering, even if it is that highly, even if it's sort of established to be highly accurate? In a meeting like this, it's actually quite critical to have the clinicians sort of work through that chain of evidence to establish the overall clinical utility.
I thought everyone would agree that they did really an excellent job of that. The questions started, a good chunk of them, the first four questions were actually not related to EsoGuard at all. What the moderator wanted to establish was why has this paradigm, which the gastroenterologists, including gastroenterologists on the call, who were actually writers of the guidelines that urged endoscopy for now a couple of decades in this target, in this well-defined target population, why did it fail as a screening test? Why do only approximately 10% of eligible high-risk patients, did they undergo endoscopy during this, you know, decades of recommendations from guidelines? They nailed this. They really established a wide set of reasons as to why this is the case. Dr.
Glover was quite articulate in describing the difficulties that physicians, family physicians have in getting patients to agree to invasive testing, the hassles, the expense, the invasiveness, et cetera, as obstacles, intrinsic obstacles to getting people to use that such as endoscopy for this type of screening application. All sorts of issues around patient compliance were clearly identified. There was some excellent conversation around endoscopy deserts about the fact that in rural North Carolina, where Dr. Shaheen practices, or in rural Colorado, where some of Dr. Glover's patients come from, just simply do not have the endoscopy resources, sufficient physicians who could perform these tests, even if they did refer them to that. Dr.
Panzarella pointed out that as in private practice GI, that he could not even, even if all of the, even if the primary care physician sent him all these patients who were recommended for testing, that he simply could not incorporate them into his practice. All of the physicians across multiple specialties, academic GI, private practice GI, surgery, and primary care all agreed that there was this significant unmet need, that they had already established the paradigm. The paradigm is completely straightforward. They know who these patients are. They are patients who have symptomatic heartburn and have three out of six well-established risk factors. When you have that, you have about a 10% chance of having a precancerous condition and that those patients should undergo screening.
If they progress from early cancer, precancer to late precancer, they can undergo an ablation procedure, which can eliminate the progression, prevent progression to cancer. Everybody agrees on that. What they also agreed is that there's a missing link that they needed, which is a non-endoscopic approach, and that EsoGuard is that missing link and provides the opportunity to now pull people into the pipeline so they can get tested and we can proceed to find this disease. The chain of evidence continues from that. You start from, okay, there's this unmet need. Do physicians use the EsoGuard test appropriately to send the appropriate patients to endoscopy and those who don't need it away? That data is published. There's published data on that. They highlighted the fact that yes, EsoGuard provides near perfect concordance with the physician referrals, have a nearly perfect concordance with the results of the test.
What I mean by that is that 100% of the patients who are positive on EsoGuard get referred for endoscopy. Dr. Glover and Dr. Panzarella both concurred that that was the case in their existing practice. As importantly, essentially none of the negatives, 99% do not, of the negatives do not get referred for endoscopy. That's a very important consideration. I said this on several previous calls that payers care about that. They don't want to pay for a test and then have you do the endoscopy anyway. There was some actual interesting conversation around whether they should limit payment for endoscopy in someone who had a negative test. That shows you kind of, you know, in the real world how this is front and center on the minds of these patients. That's the physician behavior part of it, physician referral part of it.
Another very important part, which was a central part of the discussion as well, was how do patients respond? If a patient is referred for endoscopy, they don't get the endoscopy, then the test doesn't really have much utility, does it? That was an important part of the conversation. The fact is, again, there is published data on that. We've demonstrated that about 85% of patients with a positive EsoGuard study within a window of time that we assessed it did actually get the endoscopy that they were referred for. That's a very high number, higher than other types of tests in which a follow-up endoscopy is indicated. The physicians concurred with that. Dr.
Glover, in particular, the primary care physician, was quite, again, potent on that in that she explained that most of her patients were reluctant to undergo endoscopy, but the positive EsoGuard patients she had had really facilitated her ability to get them to do so. Dr. Panzarella said every single patient that he's had who's had a positive has agreed to an endoscopy. Extremely important. They also highlighted published data in the literature that says historically that rate of patients agreeing to have an endoscopy is poor. It's about 40%. EsoGuard has intrinsic utility in that it at least doubles the likelihood. A patient who has a positive biomarker test on their own tissue is much more likely, twice as likely, to proceed with the next step than someone who's just being recommended a test based on risk factors alone. The next area is, okay, now you get the endoscopy.
What is the value of EsoGuard? I already hinted at this. Again, lots of discussions around this, widespread consensus that EsoGuard enhances the value of the endoscopy, the rule-out test. Here we have published literature, but the clinical context that they provided was critical. They all agreed that the two and a half to three times increase in the diagnostic yield of endoscopy was extremely important in the use of this invasive test and of those resources. All of that lined up well. There were other conversations which were a little bit in the weeds I won't get into that related to whether a large study from the U.K. was generalizable to the U.S. in terms of demonstrating that if you do non-endoscopic testing in general, you can find a lot more disease. That study showed that practices that used it were able to find 10x as much disease.
The physicians highlighted that that is certainly generalizable to the U.S., and EsoGuard would certainly do as good, if not better, than that 10x difference because EsoGuard is a vastly superior test to the test that was used in that study. In fact, Dr. Shaheen was one of the lead authors in a study in the U.S. that demonstrated the poor performance of that test, the Cytosponge device with an immunohistochemical test. Strong consensus on that. That really, a little bit in the weeds there, but it really represents that chain of evidence of clinical utility. That really is at the heart of this meeting.
Frankly, that's why we believe this meeting was called, to get the physicians to flesh that out and to really lock down that chain of evidence on the intrinsic utility of the EsoGuard test and why it's really not just reasonable, but reasonable and necessary, which is the criteria for Medicare. Another important part that came up repeatedly, kind of peppered throughout the meeting, was guidelines. There is strong support by the major societies, the American College of Gastroenterology, the American Gastroenterological Association, in their guidelines and practice updates on non-endoscopic testing such as EsoGuard, as well as on the overall paradigm of this test. Once patients are identified who have esophageal precancer, everything from that point on, we like to talk about sort of EsoGuard's handing the baton onto existing data, has been well established by, frankly, many of the folks who are on this call.
The idea that once you know someone has this precancerous condition, Barrett’s esophagus, that doing surveillance on them with repeated endoscopies and intervening on them with ablation works. There is a full consensus around that. The societies recommend that. In fact, the payers pay for that. They pay for those endoscopies and that ablation. The fact that that's well established within guidelines was crystal clear. It wasn't a coincidence that MolDX invited the actual authors of these guidelines to be there to testify to that fact. As I mentioned, all of them, all the major ones were present and reiterated that point. All of that points to the, you know, what they're looking for is that there is a high, remarkably high benefits-to-risk ratio for this kind of test. That is really the substance of the clinical data.
There was also an extremely important element of this, which was around the clinical, real-world clinical experience. That's why the MolDX group invited primary care physicians and a private practice gastroenterologist. They very much explained their own experience and the value that EsoGuard has provided within their practice. Dr. Panzarella discussed how he utilizes the test in his own practice. Actually, not just from primary care physicians, but patients who are referred to him for endoscopy. You can identify there's a lot of overlap between the risk factors of patients who are referred for endoscopy with those who are referred for colorectal cancer screening and those who should undergo that. He's incorporated that into his practice over the last couple of years. I think at the end of the day, one of the major highlights was Dr. Glover, the Primary Care Physician.
I think as those of you who've been following us know, the vast majority of these patients never ever see a gastroenterologist, and getting Primary Care Physicians to buy into this paradigm and buy into this type of testing and to EsoGuard in particular is extremely important. Dr. Glover provided a very, very potent demonstration of that. She acknowledged that she's a skeptical physician and bases her decisions on adopting new technologies based on guidelines. She offered a very powerful anecdote. She had her very first two patients. Once she had read the data, understood the guidelines, and said that this is something that she knows her patients would benefit from, particularly because of the issues with compliance for referring for invasive tests, those first two patients, one of them was negative.
She felt perfectly comfortable on the negative patient telling them because of the high negative predictive value that they were good to go, that she was confident that they did not have a precancerous or cancerous condition. The more potent story, of course, was one of those first two patients who was a positive on EsoGuard. That patient underwent endoscopy by one of her local gastroenterologists, and it showed initially high-grade dysplasia or a late-stage precancer, which was great. Everyone was happy. Wow, that's great. We found this late-stage precancer. The right thing to do for that is to send them to an advanced endoscopist, gastroenterologist who can do the appropriate eradication treatment and make sure that high-grade dysplasia, which is at high risk for developing to cancer, is eliminated. Absolutely coincidentally, that patient was sent to Dr. Rouhani, who was one of the other panelists here. Dr.
Rouhani, as he acknowledged, took that patient with the expectation that he would be going in to treat high-grade dysplasia, and he found that the patient had the earliest stage precancer known that we now call the T1A cancer, a very small little patch of cancer that hasn't even penetrated through the superficial layers. He was able to remove that with endoscopy and cure the patient. Here's, again, one anecdote, but anecdotes can be powerful. Here's a patient in whom EsoGuard clearly found the earliest stage cancer in a patient who we know at some point in time—was it a year, two years ahead? Unclear, but would have certainly progressed to invasive cancer if this hadn't been detected early. You can't find that in a published peer-reviewed paper. That is why this meeting was called. It was for those types of insights and that type of clinical context.
We believe that the clinicians hit it out of the park by providing real strong clinical context for what we really have always believed is very strong clinical data. What happens from here? This meeting, as Matt pointed out in the beginning, is an advisory meeting. It was meant for the MolDX directors, including Dr. Ben Wilmer, who was leading the call from Palmetto , as well as his colleagues at the other three, to provide them with the context. Dr. Ben Wilmer, at the very end, made it very clear what the goal was here, which was to get that clinical context and that he was grateful for their input and that he stated it would be helpful in their process of reviewing this request for reconsideration. We were extremely happy by those closing remarks. From this point on, the next steps are very straightforward.
The next step was the publication of a draft LCD, draft Local Coverage Determination, that is basically a response to the request for reconsideration that says, yes, we agree. The data is robust. The clinical context provided by the CAC meeting was excellent and sufficient. We are proposing in a draft coverage to reverse the non-coverage aspect of this and provide coverage to EsoGuard. As we said before, that is the milestone because if they chose not to do that, they wouldn't publish a draft LCD. The publication of draft LCD is a firm indication that they intend to cover this. There is, as I mentioned before, a process that has to continue from that. There's a public comment period, a 45-day window that includes a public meeting where input is incorporated. That results in a final LCD.
Subsequently, the EsoGuard test would be included in the articles and we'd have coverage. We stated this before, but there's a one-year window prior to a look back, prior to the date of the final LCD, where we can submit claims under the LCD and get paid. We believe we're in those final steps. Now, how long is it going to take? That's the $64 million question. We think we're pretty close. We're pretty soon. Everything about the process of how it was set up, the comments during the meeting from MolDX leadership gives us a high level of confidence that this is in the final stages, that they're strongly inclined to proceed accordingly. The analysts have put some timelines onto what they think the timeline is for us to receive a draft LCD, and we would concur with those timelines.
Let me end there and just summarize by saying, you know, we weren't sure what to make when this notice went out, but pretty soon after, based on consultations with MolDX leadership and others, we were happy, actually, that this meeting was put into place. We expected it to be positive and to highlight and give a public forum for the quality of the data and the clinical context. We're extremely happy with the selection of the experts. They're a really excellent group, a diverse group of folks. We went in, you know, quite optimistic. As I said, the meeting really exceeded our expectations. We believe it puts us in a great position to move on towards Medicare coverage in the very near term. As we've talked about before, I won't go into much detail, but you know, Medicare is important for us for two reasons.
Although our current Medicare population of the patients we've been doing to date has been low, we've never really made any effort to find Medicare patients. Many of our patients tend to be on the younger side because we've had a high number of them within our Check Your Food to Firefighter events. We know about half of the patients in the target population are Medicare. As we said on our earnings call, we are moving towards trying to move that 10% number towards that 50% number. Having really even the prospect of near-term Medicare coverage is helping us do that. As we also discussed, certainly when it comes to the larger commercial payers, Medicare is an important milestone. Medicare has established pricing, which we think is important, and Medicare coverage really sets the bar for the larger plans.
We still think we will continue to have success with regional plans while we're waiting for Medicare coverage. Medicare coverage is extremely important for us on the commercial side as well. I think we'll look back at this meeting as a real inflection point in our pathway to provide broad patient access and to really be in a position to ramp up our commercial activity to take advantage of this really large total addressable market. With that, I'll ask our operator to open it up for questions.
Thank you. Ladies and gentlemen, we will now begin the question and answer session. To ask a question, you may press star followed by the number one on your telephone keypad. If you're using a speakerphone, please pick up your handset before pressing the keys. To withdraw your question, you may press star followed by the number two. With that, our first question comes from the line of Mark Massaro at BTIG. Please go ahead.
Hey, Mark.
Hey, guys. Thanks so much for a helpful discussion of the CAC meeting and congrats on a really positive-toned meeting. One of my first questions is, it really stuck out to me that there was consensus around only about 10% of these eligible patients are getting screened with standard of care endoscopy. If I have this right, I think that compares to around 40%- 50% of eligible people that get screened for colorectal cancer. Just at a high level, Lishan, you talked about EsoGuard having a remarkably high benefit-to-risk ratio. If I have this right, if you could get 10% of people screened to anywhere near where colorectal cancer screening is at, 40%- 50%, that would potentially represent a four to five-fold increase from where we are today. I'm just trying to frame that. Am I on the right track in terms of just incremental? Yeah.
100%, Mark. Actually, I think your numbers may be a little bit low on the colorectal side. I've heard numbers that even at the point of introduction of colorectal stool-DNA testing, that number was at 50% or maybe even a bit higher. We're higher than that based on the volume of testing patients who undergo colorectal screening. I would say you're, yeah, even it's probably higher than that, that we're at 10% and colorectal is, you know, 60%, 70% or more. Even that 10% number, there's a strong consensus there. Honestly, our personal opinion is that number is actually on the high side.
If you look at the target population and you look at the number of endoscopies, upper endoscopies performed a year, just all of them, you just look at administrative data and you just look at all the numbers there, it doesn't add up, actually, that it's even 10%. We know there are 30 million people who are recommended by the most strict guidelines, by the ACG guidelines. 10% of that would be 3 million. There are only about a million plus upper endoscopies. The vast majority of those are not screening endoscopies. The vast majority of those are people undergoing upper endoscopy for evaluation of their refractory heartburn or other esophagitis or other conditions. We'll go with that 10%. It's perfectly fine. We think that real number is actually much, much lower than that. You're right.
Increasing that 10%, let's just say to 30% in the coming years, would have a massive impact. I forgot to quote Dr. Panzarella, but he pointed out and said he liked sports metaphors and pointed out that, you know, the number of people who die a year from colorectal cancer could fill a football stadium, but the number who die from esophageal cancer would fit a basketball arena. That's a lot of patients. Going from 10% to 30% would represent thousands of lives saved a year. I think, again, the experts nailed that with regard to the huge benefit-to-risk ratio that we have the opportunity to perform. I think, as you're hinting at here, even higher opportunity than even in colorectal cancer because for a couple of reasons. One, because there was already significant penetration of endoscopy, colonoscopy there.
Frankly, another reason is that colorectal cancer picked up early and stage one actually is curable, while stage one esophageal cancer, the vast majority of the time, is not curable.
Yep, that makes sense. Another thing that stuck out to me was Dr. Jamie Glover talking about how it's really just general health anxiety, which I thought was interesting. The reasons for non-compliance to endoscopy, procedure burden, some of these folks, especially people that are obese or are smoking, there's a laundry list of things for them to do. The PCP doesn't have enough time to go through the laundry list. The patient feels stressed out that they can't manage all of the things on the laundry list.
I guess one of my questions is, how do you try to get, and this might be a marketing question, but how do you try to promote getting screened for esophageal cancer or Barrett’s when the population that you guys are testing has multiple risk factors, right? It also occurred to me that some of these patients, of course, you've been talking about this for years, have no symptoms of GERD, right? How do you position this test such that the PCP can prioritize this test? It's almost like, in some ways, this might be competing with colorectal cancer screening or lung cancer screening or other types of tests on the laundry list that need to be done in a given patient encounter.
Okay, lots to unpack there, but great question.
First of all, let's just put one thing to rest, which is the asymptomatic patients, because as you know, that came up, right? You're right. The panelists acknowledged that there are a large number of patients who either have well-controlled symptoms on PPI medications or just have no symptoms at all. The questions asked by the moderator did attempt to tease that out. If you remember, your guidelines right now only refer to symptomatic patients, but we're going to miss half these patients. I thought the panelists did an excellent job of saying, yeah, but you know, you got to start somewhere. The symptomatic patients are going to be easier to get them to proceed. We'd love, and certainly at some point in the future, we've talked about this on multiple calls, that we do expect that there'll be an expanded clinical opportunity in patients who are asymptomatic.
As you know, Mark, there's an $8 million grant funding an NIH study right now that's looking at that. The pilot data from that looks pretty promising that patients who are asymptomatic have almost the same prevalence of precancer, and EsoGuard works equally as well in those. That's for the future. Right now, the focus is on those who have symptoms. I think as it relates to the dynamics within the primary care office, let me just talk about that a little bit. From a marketing and a commercial point of view, we don't have any concerns about that. We've been marketing this to primary care physicians at a low, kind of at a low level for many years now. It's just not an obstacle.
When our team walks in and reminds them of the relationship between cancer, between heartburn and cancer, and the guidelines and the availability of a non-endoscopic test, getting them to move from that to, okay, let's look at our EHR and let's find the patients who fulfill this and let's get them tested, it's not a hurdle to get them to agree to start doing that. There are some details there that are important that actually came up, particularly as you mentioned with Dr. Glover. The issue is not so much prioritizing it because primary care physicians are actually quite good at running through the checklist and like, okay, when's your next mammography? Should we do stool-DNA testing? Do you need a colonoscopy? Should you get a PSA? That's kind of their bread and butter of what they do.
Adding this to that list is not, in terms of the conversations and discussions, hard. What she clearly pointed out is that if what they're asking their patients to do is an invasive upper endoscopy, she gets nowhere with that. She has no, the patients are just reluctant to get that. As I mentioned, there were all the other factors that interfere with their ability to implement that. The notion of offering patients precancer testing is something that is easily incorporated in their practice, but the utility comes from EsoGuard being non-endoscopic and straightforward and something that patients are willing to have. I think Dr. Panzarella might have mentioned this, if he hasn't, but this is true, that the patients that he refers for EsoGuard and EsoCheck, the cell collection part, they universally agree to do it. There's a high compliance with getting people to do that.
As you know, that's actually not always the case with regard to other even non-invasive tests like stool-DNA testing. The other part, which I'm glad you brought this up, that came up because the MolDX, the MACs, and Dr. Ben Wilmer were very interested in the implementation side of things. It was critical to, again, the two of them provided that highlight, that it's been easy for them to incorporate this into their practice. Dr. Glover pointed out that she is looking forward at some point to having her and her team perhaps offer the tests themselves, but the fact that Lucid clinical personnel who are highly trained make themselves available to do the test on whatever interval of time, she can collect sufficient patients to do that. It greatly facilitates the ability to do that. Dr. Panzarella concurred, right? He's a GI in practice. He's done it.
He didn't mention it, but he's done it himself. He's done it himself, had the test. He can do them in between. One of the things that facilitates that is that the Lucid clinical team comes once a month to his practice to test people. Actually, this is in Florida, where some of you who followed us know we have a mobile van, and the mobile van pulls up to his practice and tests patients once a month. The logistics, the implementation part, which was an area of questioning here, was important for the MAC directors to hear. That is a very critical part of the clinical utility and why we have, frankly, no concerns. Sorry, one other thing that they mentioned at the hurdle, I believe Dr.
Smith did, and I forget one of the other physicians did as well, was like, you know, one of the reasons why they're not doing this more is they don't have coverage. You know, Dr. Smith has done a bunch of, has participated in a bunch of testing by overseeing firefighter events here in New York City, but the obstacles for him to bring it into a large medical center where he's the Associate System Chief has been one of those is coverage. He pointed out that they need to have coverage in order for them to implement it broadly within their practice. That's why his group, the AFS , has been a very strong forceful voice in that.
Once we have coverage, I really, really sincerely don't see any meaningful obstacles to us getting primary care physicians to use this and to drive patients into this paradigm of testing.
Okay, great. Maybe one last two-parter for me, and then I'll hop off. There was a lot of discussion, as you pointed out, about these endoscopy deserts, patients having to drive like an hour and a half, two hours to get, you know, a scope, an EGD. Do you have a sense for the location of these? Presumably you could set up a shop to help provide an alternative to people having to drive a couple hours for an endoscopy. My second part question, I think it was Dr. Smith, talked about how EsoGuard could be used as a point-of-care test in primary care physicians' offices. I thought this was really interesting.
Really my question is, where do you see the bigger opportunity? Is it primary care? Is it GI offices? Is it both?
Yeah. Okay. Let's maybe again just, yeah, because that's on my brain work. Let's go backwards with Lauren. It's all of the above, right? You saw that on this call. You saw a primary care physician who's incorporated it in her practice. You saw a busy private practice gastroenterologist who's incorporated it in his practice. You saw Dr. Dunst, who's leading a team to incorporate it within a large health system with 200 primary care physicians. You saw another physician leader who is frustrated that he can't bring it into his practice because of lack of coverage across one of the largest systems in the Northeast in [MS ]. It's all of the above, but the patients are not seeing gastroenterologists, right?
The focus is on primary care physicians, but that includes, you know, the kind of, you know, the Dr. Glover model of, you know, solo or small practices where a lot of patients get their care, but it also includes the Dr. Dunst and Dr. Smith model, which includes health systems that have primary care physicians, networks that you can move within, and getting them to be done there is relevant. What Dr. Smith mentioned with regard to point-of-care testing is happening today. That's not, you know, there's nothing new about that. He sees the value in that, in that we can, we don't need to send patients to a tertiary center or, you know, to a specialist to have the EsoGuard test done. It can be done as a point-of-care test within a physician's office, including a primary care physician's office.
If the primary care physician wants to have their own personnel trained to do the cell collection, great. Our team will go in and train them to do that. If the primary care doctor wants our team to offer that, same thing. Great. We'll offer that as a service using the mobile van or using our satellite model where our nurses come in on regular days to do testing. If they want to do a hybrid, that's fine too. If they want to transition from us to doing more of theirs, which is some of the practices they're talking about, all of that is within the realm of possibility. That gets to the heart of, I think, your first question, which is around the rural, you know, the endoscopy deserts mostly in the rural areas. Yes.
There are large areas of the country where there are, you know, we know this about all specialists. There's nothing unique about that for endoscopy. If you're in much of America, you know, once you get into exurbs and beyond, where, you know, there's still a large population, finding a specialist is often difficult. Often, it requires a significant drive. The ability to have testing within a primary care office or, let's say, an internal medicine practice there, as opposed to having to have people drive to go see a specialist, is extremely important to provide broad patient access. We have real-world examples of this. I'll give you one in particular. When we started in Arizona, we started with some physical Lucid test centers. There were several of them, and people would come get referred to our physical centers to get tested by our nurses. That worked fine.
The catchment area there was, you know, maybe 45 minutes. People would be willing to drive, but that was probably about it. A lot of people are within 45 minutes of metropolitan Phoenix, but that still doesn't cover a lot of folks. Frankly, the way this whole idea of having patients go, having our nurses go to the physician offices and offer the cell collection there arose from an unmet need where there are patients throughout rural Arizona and Globe and, like, I think, like Havasu and other places where physicians are like, yeah, I'd love to do this, but my patients are not going to drive to Phoenix. Our team said, okay, we'll come to you. Now they have scheduled testing days at these rural or somewhat more remote practices outside of metropolitan areas, and it works great. The nurses show up.
We try to get the physicians to fill up a day. Our nurses can do up to 30 of these in a day, and that would be sort of an ideal day. It's very economical for us, and it gives us a much broader geographic range in order for us to be able to provide wide access. All of that, that whole model is well worked out and will be critical once we get broader coverage to put our foot on the gas and expand the use of this cost. Hopefully that answers all the multi-part question, but hopefully that covers that.
It does. Thanks so much. Congrats, guys.
Thanks, Mark.
Your next question comes from the line of Kyle Mikson with Cannacord. Please go ahead.
Hi, Kyle.
Hey, guys. Congrats on the positive CAC meeting. Tone was great. Maybe just taking a step back and thinking about any kind of prior comments that were made. We're just thinking about what you know, what's kind of changed here, because that's sort of the key going forward. Lishan, could you just speak to how the group's comments, I know a lot were KWALs, obviously, differed from prior MAC feedback and responses to the comments after the original LCD? How that, you know, why you're more positive, confident now?
It's because there were different meetings, you know. I think what you, I assume what you're referring to, Kyle, is the first CAC meeting that occurred in 2021, in the fall of 2021. That meeting occurred after we had submitted both our pricing and coverage dossier and after we'd actually already received pricing for MolDX, but before we had any data. All we had at that point was the single paper, the original paper in Science and Science Translational Medicine. We had expressed our intent to go out and expand our clinical evidence. The purpose of that meeting was to say, okay, we have an area of testing here that looks extremely promising. It's an area we're probably going to have to deal with at some point. The contractors were basically saying the MolDX program was basically saying, should we even get into this space at all?
Should we just wait till somebody has sufficient data and then they can come back to us at all? Should we bother drafting an LCD to help guide those who are looking to advance tests in this situation? That CAC meeting was a little bit different. It was a little less organized, to be blunt. Dr. Ben did not moderate that one. It was a little bit, there was some conflation between surveillance and, sorry, between risk stratification and screening. There was at least one common member, Dr. Meltzer was on that call. One of Dr. Iyer's colleagues from Mayo Clinic was there. It was similar. There were only four panelists at that.
That was actually a very positive meeting because even though some of the logistics were a little bit difficult, the widespread consensus from that meeting was, yes, we believe in non-endoscopic testing as an important biomarker testing, as an important advance. Yes, you guys should take the time to proceed along this way and not simply wait for somebody to come show up with a full clinical evidence package. With nothing, that CAC meeting, we believe, is what triggered their decision as a group of MACs to actually proceed with the LCD process at all and to actually write a draft LCD that came out five months later. That one had a few problems and required some comments. It was all, those problems were all fixed and then it ended up in a final, in a final LCD.
Many aspects of the conversation from this meeting and that meeting were very similar in addressing the unmet need, the failure of endoscopy, all of the underlying information around the brutal nature of esophageal cancer and the paradigm that these gastroenterologists have established and the societies have established. All that was quite common. The purpose of that meeting is, should we get started in this at all? The answer from that meeting was yes. This meeting was, they were obviously already done that. This meeting is like, should we get this thing wrapped up? Honestly, that's how I would view it. It went beyond simply, is there a need for this? They had already established that by publishing the LCD and establishing the coverage criteria. It was included, is there clinical validity and clinical utility actually in EsoGuard? That's how I would correlate those two meetings. Great question.
Okay. That was great. No, I think what the, you know, back, I feel like the education usage has matured basically in those, you know, I guess four years or so. That's a good commentary. Now, just on the, you know, clearly during the meeting, the EsoGuard was spoken as being like a rule, an effective rule-out test given the high NPV. Dr. Panzarella, Chak, Shaheen, Glover, they all kind of spoke about this. Obviously, it was one of the questions. The current LCD, though, does mention a test should be highly specific. Given EsoGuard's specificity has never been above, let's call it like 82% or so, do you think that's something that will have to improve over time? Could that, you know, being a rule-out test rather than a fully rule-in rule-out, would that limit the market opportunity or the ability to widen the funnel for GIs or endoscopists?
Okay, great. Let me, again, just do my practice here. The answer to the last question is no, it doesn't limit it. That was, frankly, the point of a multi-part question about making the distinction between rule-in and rule-out, right? The whole point of that conversation, and you saw how Dr. Ben Wilmer kind of navigated that conversation around, and I was happy that he did this, making a distinction between rule-in and rule-out and focusing on NPV and PPV, although specificity obviously is mentioned, but specificity is what drives your PPV. The way these rule-in tests are designed are to, sorry, rule-out tests are designed to rule out patients who have a maximal sensitivity and a maximal negative predictive value. Dr. Shaheen mentioned, look, it's got to be 98% or higher for this to work. You can't have a false negative rate that's much higher than 1% or 2%.
There was plenty of discussion around what is a sufficient specificity and resulting positive predictive value for a test like this that's designed and operates, and its utility is based on its ability to rule out tests. The 30-ish, right around 30% positive predictive value is really actually very good in that, and for a variety of, by a variety of metrics, one of them being that, as was discussed, it increases the yield of the standard of care endoscopy by two and a half to three-fold. The positive predictive value of an endoscopy, the gold standard, as they mentioned, is 10%, right? That's what the prevalence of the population is. If you just do endoscopies on patients like they had recommended for the last couple of decades, you're going to have a 10% positive predictive value. The specificity of endoscopy is not good.
This test increases that by two and a half to three-fold to 30%. As you balance NPV versus PPV, that's very good. The PPV also is quite strong when you look at the positive predictive value of other tests that are focused on identifying cancer, whether it be.
know, lung cancer testing or, you know, mammography, even colorectal cancer testing. This is really a very good PPV. That goes to the heart of the question of specificity as it relates to the market opportunity. No, this test is—the whole paradigm here is to hand patients, to find these patients that we're not finding and hand them over, basically pass the baton on to the existing paradigm of surveillance endoscopy of non-dysplastic, you know, early stage precancer and ablation and intervention for late stage precancer to prevent cancer. That's the paradigm. This test as a rule-out test with a PPV that increases the yield of the endoscopy serves that purpose today. There's no gap in that market opportunity.
The market opportunity that we've quoted is based on the 30 million patients who are indicated for testing, and every single one of them is indicated for testing, would qualify for testing under EsoGuard under this paradigm. Now, look, in the future, you're right. In the future, there are always opportunities to improve the test. When you design a test like this, your first shot is what was done with this test by Dr. Markowitz, Dr. Chak, and their team at Case Western, which is to get the maximal NPV and a very good PPV. Over time, you, and we already have, we're already working on this. You look for ways to say, hey, are there ways for us to improve the specificity and increase the PPV even further? There is a way to do that. There's a history of this.
This is exactly what Cologuard did from Cologuard to Cologuard Plus. I don't know, eight to ten years between those two products, they came up with improvements. The improvements in sensitivity and negative predictive value, frankly, are not that much. A little bit, a few points on advanced adenomas and cancers. The big improvement was more on specificity and positive predictive value, from more of a healthcare economics point of view, to really cut down the number of endoscopies and so forth, the yield of endoscopy even further. That’s true. The long-term era, I think Dr. Shaheen may have touched on this, the ultimate holy grail goal, sure, would ultimately be to have a completely non-endoscopic approach to rule in and rule out.
We may reach that point as these biomarkers improve, where you can do the test and feel comfortable that you've ruled people in and you've ruled people out, and the patients who are being ruled in are going to be heading into a definitive treatment. That's certainly the ultimate goal. The current breakdown between NPV and PPV is excellent and serves the purposes of the current market opportunity extremely well.
Okay, super helpful. A lot more to talk about, but I'll hop off given the time. Thanks.
Yeah, great.
Thank you. If you would like to ask a question, simply press star one on your telephone keypad. Your next question comes from the line of Mike Matson with Needham. Please go ahead.
Hi, Mike. Yeah, thanks. I mean, congrats. It was clearly a very positive meeting. There was an interesting question that came up on the call from someone at CMS, or I guess maybe it was one of the MACs, I'm not sure, but they said something about, they were asking something about not allowing EGD in patients that have a negative EsoGuard result. Did I hear that correctly?
Yeah, yeah, not quite. Yeah. Okay. Yeah, yeah. It was interesting. It gives you guys a bit of a, I thought it was an interesting, it does not really have any impact on us, frankly, but it does give you a little impact, a little inside view, inside baseball view on how payers think about this stuff, right?
The question was really, well, if you guys are so confident that a negative, which you should be, that a negative EsoGuard test rules out disease, then we should not pay for the endoscopy of a test if a patient is negative. That is effectively what the director, I believe, from CGS was asking. That is a perfectly reasonable question. We are fine with that. We are highly cognizant, in fact, us at all. We have shown that a negative EsoGuard test results in 99% concordance for physician practice. They do not refer those patients to endoscopy. They are just saying, hey, we should not have to pay for that, right? There was a little bit of pushback, and the pushback was reasonable, not because the gastroenterologist had any concern about the false negative predictive value.
They were just concerned that, you know, as bureaucracy goes, if there was sort of some kind of blanket exception to anyone who has undergone an EsoGuard test can sort of never get an endoscopy, they were worried that you would inadvertently pull in other patients who clearly need endoscopy for other reasons, not for screening, but for other reasons, for evaluation of refractory GERD, for esophagitis, for yearly, just the whole sorts of other things. They were just nervous that such a criteria would have inadvertent consequences. Frankly, that is something that the payers will work out with the GI societies as it relates to that. It has no impact on, frankly, on us or on EsoGuard.
Okay, got it. Just wondering, does MolDX consider economics at all? In other words, I guess, what if they're like, this is a good test and it all makes sense to cover it, but we're worried that the $1,938 is just too much or it's going to end up costing the system too much money. I mean, it's hard to make that argument, I guess, when you consider the fact that they'll be preventing a lot of endoscopies potentially in some of these patients, which are clearly more than that. Just wondering if they weigh that stuff at all or if it's really just a fact.
The straight answer to your question is no. Medicare is not allowed to consider economic factors in making coverage determinations. They're only allowed to base their coverage determinations on what's reasonable and necessary, quote unquote. That's the criteria. They are not. It's a great question because it does a couple of additional points there. One is that they're the ones who came up with the $1,938 price. Remember, that's Medicare's price. It's the same group. It's the same MolDX group that recommended that price. At the beginning, five years ago, when we started this process, we submitted, in addition to a coverage dossier, a pricing dossier and they did a full analysis of what would be a justifiable cost based on a variety of factors and came up with that price. The healthcare economic impact is not a factor in their decision with regard to coverage.
However, it is with commercial payers. We have a very robust talk track and arguments that we can make on the healthcare value proposition for EsoGuard testing. It's good. We have modeling that demonstrates that EsoGuard testing, even though endoscopies are not widely used, and certainly a cynical payer can, there's this very, very crass and cynical argument that death is sort of cheap, right? It really isn't because patients who are diagnosed with esophageal cancer, 80% of them die, but before they die, they spend a lot of money, which is now pushing a couple of million dollars before they die to the healthcare system. It's actually quite expensive. Our modeling is quite straightforward. It shows that with the typical parameters and parameters that other payers can adjust on their own based on their own patient populations, EsoGuard testing is a net economic positive.
One of the things that we've learned in our, I'll use this as an opportunity to highlight something. We have extensive conversations now with the commercial payers. In their case, as I said, the issues of economics come up. One of the things that's been very gratifying in our recent conversations is that they don't do what you sort of said, to kind of take the cynical approach, which is, we're not paying for these endoscopies anyway. We're not going to give you credit for avoiding endoscopies in 70%- 80% of these people because we're not paying for them anyway, because the patients are not getting them. That actually hasn't been the conversation. We actually have been quite pleasantly surprised now that we're in the meat of these policy discussions.
That's only been true for the last few quarters because now we have the full data package to engage in these conversations. To the contrary, we've gotten strong feedback that, yeah, there's an economic value in the fact that you're avoiding endoscopies that should be performed in these patients based on guidelines. That's very encouraging as it relates to our ongoing conversations. That's a bit of a long-winded answer. I thought I'd throw some of that in there. The straight answer to your question is Medicare does not take economics into consideration.
Okay, got it. Finally, I don't know if you're able to answer this, but because of the one-year look-back window, assuming you get the MolDX coverage, how many Medicare tests or claims do you have that would fall within that period? I guess you don't know because it depends on when this happened. Also, let's just put aside the number. How does the mechanics of it work if you had a thousand tests that were in the window and you submitted all of that? Would you get it all at once or would it be spread out?
Let me answer the last part. The mechanics are straightforward. Once you have final, the ones that we can submit, the one-year look-back, and this is from a horse's mouth because I inquired on this in my conversations with the leadership directly. The one-year look-back is dated from the date of the final. You start submitting after you get the final. There's this last step where CMS Central, there's a little bureaucratic step where you end up in the sort of list of articles where our code is actually listed after the final LCD. That's when you start submitting. Once you submit, the mechanics are straightforward. You get paid. Simple as that. Whatever the one-year backlog is, you get paid. Medicare is actually a pretty good payer in terms of their, you know, they don't have long lead times. When you submit, you typically get paid rather quickly.
The number of patients, a little bit hard to say. I'll see if Dennis is willing to maybe flesh that out a little bit because, you know, we have this program now where we are pushing our team to target Medicare patients. Over the coming months, the kind of the success of that and whether we're at 10% versus, you know, 15% or 20% or, you know, pushing higher than that will determine the number of claims, outstanding claims that that one-year backlog, that look-back will have. You can, you know, kind of do the math. Look at the percentage, look at our total volume, look at the percentage of the volume that is Medicare. You can project what that would be in the coming months. Medicare will pay at the Medicare rate and pay, you know, promptly at the Medicare rate once this whole thing is final.
Dennis, I don't know if you'd like to flesh that out a little bit more.
Yeah, I can give you some perspective. If it were the 2024 year, it would have been somewhere between $6 million and $8 million. In the first half of this year, it's probably about $2 million. As Lishan said, we're going to start focusing on Medicare patients. If it's in the 2025 window that all of those claims will get paid, it'll be higher than $2 million. That's probably as general as we can probably make it.
Okay, got it. Thank you.
Your next question comes from the line of Jeremy Pearlman with Maxim Group. Please go ahead.
Hey, Jeremy.
Good morning. Just one quick, hi, how are you doing? One quick question. It seems like the meeting went really well, but just to play devil's advocate, let's just say, you know, I've heard crazy stories. You don't get the positive, you know, draft letter. Is there an appeal process? What would be your steps if, unfortunately, that came about?
Yeah, you know, look, I mean, I think it's fine to play devil's advocate. Nothing is certain when things are out of your hands. I'm not sure it's worth speculating what that is. There are lots of avenues to appeal, to make that case. It's not really worth speculating on what that would be. We're really confident. It's just a matter of when, not if. I'll just point out, let me just point out one other, there's lots of reasons. Hopefully, I've articulated why we're confident in that. I can't predict the timing precisely because that relates to internal logistical aspects here. I would say that the fact that the director of the program moderated this meeting and everyone could sort of see his demeanor through the meeting and in his closing remarks says a lot about the fact where this is on the priority list.
I think some of the other analysts who are heavily focused on diagnostics will point out that that is not typically the case, that typically the running of these meetings is delegated to other medical directors. They're like, look, I mean, this is just our opinion. We have no inside information on this, but it would certainly indicate that there's a priority here and that it'll move expeditiously. The outcome, it's pretty hard to find another example. Again, I'm quoting some of your colleagues here of a test that's recommended in guidelines that has in a meeting of nearly a dozen medical experts across specialties, including the ones who wrote those guidelines, unanimously offering clinical support for the public record, which was the design of the meeting. The purpose was to get their opinion on the public record.
It seems pretty hard to fathom that we won't end up where we believe we're going to end up.
Okay, no, understood. Thank you for taking the question and congratulations.
Thanks. Appreciate it.
Thank you. Your next question comes from the line of Ed Wu with Ascendiant Capital. Please go ahead.
Hi, Ed.
Yeah, congratulations on the meeting as well. I have another quick question. There won't be any consideration in terms of your current coverage reimbursement rate from Medicare that's already been disclosed. There won't be any changes or discussion into that?
Nope. Coverage and payment are completely different pathways. The payment rate has been established based on the, we went through the, just to get in the weeds, we went through the CLFS process many years ago that culminated in a MolDX recommendation of this price of $1,938. That price is locked in. This process is completely, the coverage process is completely separate from that. Great question, but thanks for offering a chance to clarify that.
Thank you very much. I wish you guys good luck. Thank you.
Yeah, thanks, Ed.
Thank you. I'm showing no further questions at this time. I would like to turn it back to Dr. Lishan Aklog for closing remarks.
Great. Thank everybody for taking the time. I guess we're an hour and 20 minutes into this. There's clearly a lot to talk about. As always, just great questions to get in the weeds on some of this. Hopefully, it provides you with sort of a foundation as to why we believe this was an extremely positive meeting and why we're incredibly optimistic about the near-term prospects here and what that means for EsoGuard, for our ability to offer this and expand access to it, and for Lucid as a company and for its commercial potential moving forward. Hopefully, you got a sense of that and understand the underlying reasons that underpin that confidence. We're looking forward to moving forward. I appreciate you all taking the time on this one-off call.
For those of you that have been patient enough to stay to the end, hopefully, it was informative and worthwhile. I look forward to keeping you abreast of this through our news releases and other channels that we've talked about. Thanks again. Really appreciate the time. Feel free to reach out to—I guess, sorry, one more logistical thing. The meeting will have a recording. Anyone who didn't listen to the meeting, I'm not sure, typically it gets posted within a couple of weeks of the meeting. If you're looking for that link, you can reach out to Matt Riley. He can provide you with that link when it becomes available. We do have an unofficial transcript for anyone who might want to read through that. I would encourage you to contact Matt as well.
We're very grateful to our analysts who've already written some very useful summaries on the substance of the meeting, which is hopefully helpful as well. Thanks again, everybody. Have a great day.
Thank you. Ladies and gentlemen, this concludes today's conference call. Thank you for participating. You may now disconnect.