Great. Well, music's silent, I think that's our cue to begin. And we actually had a great segue from the last panel to this panel, 'cause we were talking about how what total addressable market opportunity looks like for different research tools. And, you know, often when I speak with investors, the big TAM is cancer screening that we speak to, because they're your patient population is healthy folks, is very, very broad. And with that, we've got a broad group of panelists here. AmirAli Talasaz from Guardant, Dave Daly from Exai Bio, Dave Mullarkey from ClearNote, and Susan Tousi from DELFI. Thank you all for joining us.
Thanks for having us.
You each approach the market in a bit of a different way, and maybe we'll start there with self-introductions, as well as your early indication in pursuit in cancer screening. Amir Ali, we'll start with you.
I'm AmirAli Talasaz. I'm co-founder and co-CEO of Guardant Health. We are the leading liquid biopsy player in the field across the continuum of care. We always had the vision of, you know, hopefully seeing a day that in annual checkups, a simple blood test can detect cancers at early stage. And we are very excited that finally we are seeing those days in front of our eyes. We are a company who have liquid biopsy tests across continuum of care right now. We started from advanced cancers, then went to early stage on MRD testing, and lastly, now, we have Shield, the cancer screening test with the lead indication of colorectal cancer. Our vision was building Shield as a multi-cancer screening device, but we really valued the fact that patients at the end need to get access to this test.
So we prioritize for reimbursement and regulatory pathways, and as a result, started with an indication that there's a huge unmet need in it, but also can generate the pathway for accessibility of this blood test for the beneficiaries.
My name is Dave Daly. I am the CEO of Exai Bio. I've been in the diagnostics industry for the last 35 years, and so listening today to, all that's taking place, it's exciting to see. The first test, I launched back in the early nineties was PSA. So, having seen us go from PSA testing to where we are now is exciting. At Exai Bio, our objective is to take a novel approach to liquid biopsy. My colleagues here have done an outstanding job in optimizing ctDNA, analyzing fragments of DNA in the blood. What we're doing is we're actually looking where others aren't necessarily looking, and that is with RNA.
And Hani Goodarzi and his team at UCSF have isolated these orphan non-coding RNAs that they've coined oncRNAs and then optimized or unlocked the power that are contained in those by using true generative AI. So we're categorized as both a liquid biopsy company and an AI company. And just to note, we didn't just put AI on the back of our name to add a few extra dollars in an IPO. We actually do use generative AI with a foundation model, again, to unlock the power of those RNAs. Our objective is not to try to displace the fantastic work that's been done. In fact, AmirAli and the Guardant team deserve a tremendous amount of credit for the good news of getting an FDA approval on a screening device.
It, it helps all of us, as well as patients, obviously. But our objective is to complement, using our technology, areas where with ctDNA, maybe they've hit a ceiling or there's a gap, and we can come alongside and partner to fill those gaps, to raise that ceiling a little bit more. So whether it's in colon cancer and lung cancer, partnering with industry partners, or whether it's in breast cancer, where ctDNA has traditionally struggled a little bit, we've unlocked, some answers there, where we can partner with health systems that have very, advanced mammography programs, but continue to struggle, with women with dense breast. Our technology is not confounded by breast density, so there's an opportunity for us in an area that is a true clinical unmet need to, to address that.
So it's a pleasure to sit with this esteemed group today, so thanks for having me.
Thanks, Dave.
If we only caught it earlier. If only we caught it earlier, Uncle Jim would still be with us today. We are making that a statement of exasperation, a thing of the past. We're focused on detecting the highest mortality cancers in high-risk patients, where no effective early detection tools exist today. I'm Dave, CEO of ClearNote Health. We have an FDA breakthrough designation for early pancreatic cancer detection, and the second test we have available commercially now is for early ovarian cancer detection. We combine epigenetics and genetic information to detect these early signals in changing tumor biology to help inform the decisions and the information that we provide to healthcare providers. We're based in California. We're a CLIA CAP-accredited laboratory in San Diego, and have some offices in the Bay Area as well. Great to be here.
Great. I'm Susan Tousi. I'm CEO of DELFI Diagnostics, and we are a next-generation liquid biopsy company on the heels of, you know, great companies like Guardant that have come before us. Our approach is very distinct. It's using fragmentomics, and this was a discovery from really led by Dr. Victor Velculescu, who's the scientific founder of the company, who's been studying cancer cells for his entire career at Johns Hopkins. And noticed that the kind of irregular, chaotic nature of cancer cells as they die and they shed into the bloodstream, the cell-free DNA fragments from cancer cells kind of belie the presence of cancer.
You see this in kind of genetic and epigenetic and kind of chromatin-based features that are present in these cell-free fragments that came from cancer cells that are distinguished from those that come from healthy cells. By doing whole genome sequencing of these fragments or gaining the fragmentome, you can really, applying machine learning and AI, you can discover high sensitivity detection of cancer at the earliest stages. So by, you know, training our algorithms now over 5 years and even before that, and access to many samples and the clinical trials that we're running, we have developed, you know, highly sensitive algorithms that detect cancer. We have launched our first test, and, you know, our approach, because it's whole genome sequencing based, it's low-pass whole genome sequencing.
The kind of algorithms do the heavy lifting. It is disruptively low cost, so our tests can be in the few hundred dollars. And, you know, we have ambition to be able to offer the test at population scale, because as my friends here on the panel have said, I mean, we really see this as the great equalizer, the democratizer of access to life-saving early detection. And, and, you know, you might not be near an academic medical center that has, like, all the imaging equipment, but you can get to a place where you can draw blood and, you know, have a life-saving screening test. So we believe really strongly that kind of cost is going to be an important factor of that. We launched our first test for lung cancer.
It's an LDT we launched in October. We're in commercial phase, driving adoption with health systems. Currently, we have breakthrough designation with the FDA. We are very committed to an IVD path, and, we've also demonstrated the technology for liver cancer, ovarian cancer, even multi-cancer applications. And we also have a service that we provide, called DELFI TF, which is for monitoring. It's not quite at the limited detection, MRD, but it's a monitoring application of our, of our technology. It's a pleasure to be here.
Well, I think it's fascinating that you're all approaching cancer screening, but all of you with a different lead indication. I would love to learn a little bit more about, you know, the type of analysis or thought process that went into picking... and maybe Susan, we'll start with you, picking lung cancer as your lead indication.
Sure. You know, we're, I think all of us are inspired by what Grail has done in a multi-cancer and a, you know, big approach like that. But we, we've taken a very pragmatic approach. I mean, lung cancer is the, number one cancer killer. One in five cancer deaths is from lung cancer. It's a huge unmet need. Ten years of having LDCT in the guidelines after, you know, really high quality, randomized clinical trials, LDCT is a covered test, and on average, less than 6% of the people in the high-risk population who have, reimbursed, you know, access to LDCTs actually get it done. So 95, 9-94% of the people who should be getting screened are not getting screened.
We believe that, you know, a liquid biopsy test is going to be much more accessible, practical, and, you know, for a lot of reasons. So we chose lung cancer because the, you know, there's a huge unmet need. The patient population in the U.S. is 15 million that fall in that 50-80, having smoked 20 pack years. And, in fact, if the American Cancer Society has suggested that you drop the quit- the pack year requirement or quit year requirement, I should say, because whether you- if you smoked that much, if you quit like 16 years ago or 17 years ago, you probably should be screened for cancer. And that takes the population to 20 million that are accessible for the test.
And so we think lung cancer, huge unmet need. We can close that screening gap. Our test, the way it works is the negative predictive values are very high. It's as simple as, I think Amir Ali said, like, you're in the doctor's office, point of care, you get the blood drawn. Screening gets done when it's that accessible. And it's a huge... You know, it, when caught early, the 10-year survival rate is 73%. So there's no reason why lung cancer should be such a deadly cancer. And so, you know, we've launched the LDT, and we are seeing quite good traction. I think, you know, we've talked a little bit more about, like, clinical trials and-
Sure.
The realistic demonstration.
So, unmet need, low compliance with existing screening modality. Amir Ali, can you share your, your journey there as well, in terms of starting with colorectal and then your, your lung program as well? Did you look at it through a similar lens? I'd, I'd love your thoughts.
Yeah. So I think, we wanted to make sure at the end, we have this liquid biopsy test that would save lives. In order to save lives, you need to make sure people at scale would get access to this test with reasonable kind of cost and out-of-pocket costs, which goes back into some of the classical diagnostic models of reimbursement, reimbursement, reimbursement. So, where do you really have pathways for reimbursement? Where are the pathways for regulatory approval? Because in many cases, especially for this field, they are kind of bundled together. We're also considering the market opportunity for colorectal cancer. It's the second leading cause of cancer-related mortality. There are 50 million people who, based on guidelines, need to get screened, but they are not getting screened.
You know, we have colonoscopy for decades, we have FIT testing for decades, we have other kind of stool tests for more than 10 years, and still 50 million people are unscreened. 76% of the people who die with colorectal cancer are coming from that 50 million people. So it's a huge unmet need. We want to start with that indication as our lead indication, but not the last indication. So in parallel, we started working on our pipeline. We are doing another major cancer screening study in the field of lung cancer. As Susan mentioned, actually, lung cancer unmet need is very big, too. It has its own kind of pros and cons in terms of the market opportunity, but it's an indication that, again, at the end, it's a cancer type that's the leading cause of cancer-related deaths, even globally.
We are obviously very interested to play in that market, but we are not going to go after these cancers one by one. We are looking into the pathways to expand the indication of Shield to really a multi-cancer detection device, and hopefully, we are going to have some exciting updates about that in terms of data and updates in 2025.
Dave Daly, you mentioned you were approaching the market from a complementary angle as it pertains to breast cancer screening. Can you elaborate a bit further on that?
Yeah, absolutely. You know, today, and we experienced this even at my time at Thrive, where we were using circulating tumor DNA to assess multi-cancers, and the one cancer we struggled with, sensitivity-wise, was breast cancer. And then you look fast-forward a few years, and we continue with that modality to struggle with breast cancer because it tends to be low shedding, from a DNA perspective. Remember that these oncRNAs are shed by living cells, so they tend to be more abundant in the circulation, so the ability to detect them is a bit easier. In fact, as Susan said with her technology, we don't have to sequence very deeply in order to detect that signal.
So number one, in an early detection test, cost is an issue, so the fact that we don't have to sequence very deeply is, we are a very low cost application that should translate very well to the marketplace. Additionally, I've been married for 40 years, and every year, my wife comes back from her annual mammogram and says, "Indeterminate." One year, she actually had to have an unnecessary biopsy. Lo and behold, now she understands, well, she has dense breast, and therefore, as her radiologist says, "I'm trying to find a snowball in the middle of a snowstorm." And so our ability to decipher through oncRNAs, then channeled through AI, 40 million women get mammograms each year. 43% of those women are classified as having dense breasts.
The FDA has said, all 50 states are going to have to start reporting breast density as a requirement. The task force has said they, too, are going to lean into to technology. So it represents an area where we have, high sensitivity relative to existing standard of care. 3D mammography sensitivity for women with dense breasts is 32%, and in our early serum studies, we demonstrated a sensitivity that was almost three times that. So it is, an opportunity where, with, low cost, and we provide, our data with less than a mil of blood, so again, low input. So when you start to look at the ability to address a current unmet need, where, again, ctDNA continues to shine in certain cancers, this is an area where we can come alongside.
And maybe the final point is, as we went out and did our market research, just about every health system has a fairly robust screening program for breast cancer, and they struggle greatly to try to address these indeterminates because of breast density. And we are working on a variety of partnerships where rather than us creating a commercial infrastructure to go out and try to create a market, the market already exists. We just need to plug into existing workflows, not to displace mammography, but to complement and provide insight for those women who do have that indeterminate result. Should I just continue on my normal screening regimen, or should I go for some additional imaging studies? Because the... You know, the fact is, again, women with dense breasts, 50% of their cancers go undetected.
We picked a cancer that is an unmet need, that regulatory-wise, from the federal government side, everybody's leaning in to try to solve the problem, and we believe we have a technology to do that.
In your test, I'm sorry, your test would be a reflex test after an indeterminate mammography? Is that what you envision the workflow to look like?
So again, since all 50 states are going to be mandated to report breast density, when a mammography result is reported, density will also be reported. Those who have an indeterminate with a dense breast designation, they then would be the ones that we would target, and then they would be the ones we'd provide that additional information for.
Okay. And then, Dave Mullarkey, you, you've chosen to tackle a big, hairy problem. There, there are no screening tools available for pancreatic cancer, ovarian cancer, perhaps that's arguable. I think there might be a, a test on the market, but, how did you choose the pancreatic, where you have your Breakthrough Designation? Like, why, why tackle that at the outset?
Yeah, one is we, we don't recommend screening for pancreatic cancer. We recommend focusing in on a very narrow subset of patients that are at the highest risk for developing it, that are showing some early signs and symptoms, and have that risk factor that increases the relative risk of having pancreatic cancer dramatically. So these are folks that the incidence is 6, 8, 10, 20 times higher than average. So just to clarify that, we picked pancreatic cancer because of the, the lethality of this cancer, and most importantly, because there's no early effective detection tools available today. So the unmet need was off the charts. Pancreatic cancer is about to overtake colon cancer to be the number 2 leading cause of cancer-related mortality in the United States, and it's gonna happen in the next few years. There's no way we typically find it early.
It's typically found in stage 4, stage 3. On average, you have 6 months to live. If you find it in stage 4, you have a 3% chance of survival for 5 years. It has the most extreme difference in early stage detection and its impact on survival. If it's detected in stage 1A, there's an 80% chance of 5-year survival. So stage shift, you don't have to argue if stage shift matters here. It's the most extreme of any cancer, and we feel like we could do the most good there. Yes, there isn't a clear reimbursement path for it. However, being focused in on a narrow population that has a much higher elevated risk, that's the approach that we're taking in general as a company.
The example for the Breakthrough Designation is if you're over 50 and you develop type 2 diabetes, you have an 800% higher relative risk of developing pancreatic cancer within the next few years than average. The deal is that in patients that have diabetes after age 50 and pancreatic cancer, when you remove the pancreatic cancer, their diabetes goes away. The concept is that the first symptom and sign that you're seeing of pancreatic cancer is, in fact, diabetes. These patients aren't very high BMI, it's not an A1C been rising for 20 years. Average BMI, A1C pops up, and sure enough, you go in. In fact, 25% of all pancreatic cancer patients each year have a new diagnosis of type 2 diabetes. That link is why pancreatic cancer is exploding, diabetes is exploding.
This is an issue around the globe. So we chose that one first. It's clearly, there aren't as many therapeutics out there, but as a lot of the pharma companies are telling us, if you can find patients that have pancreatic cancer and the tumor is still somewhat localized, it's a heck of a lot easier to get our therapeutics to work when the tumor is a lot smaller and it's contained, than when it's metastasized. So we believe that this will open up a path for new therapeutics, earlier intervention, and be a path to feed earlier stage diagnosed patients with pancreatic cancer for some of the early clinical trials that are needed to, in fact, prove that out.
Okay. Well, let's talk about the regulatory path for screening products, and there is an LDT route and an FDA route, and yeah, the FDA route in this category is specifically more relevant than in other categories of diagnostics that I follow. AmirAli, you just completed the first phase of your journey at Guardant. I'm sure it all went exactly to plan.
Exactly.
But would love to hear any learnings from your first iteration of running a prospective clinical trial and getting something over the finish line with the FDA.
Yeah. So first, actually, appreciation and thanks to the FDA review team. It was a true collaboration and partnership of a long and a tough journey. Like, you know, I'm not sure if I wanna do that one more time right now, frankly, but it's been a great result at the end. You know, look, like, running a 20,000-patient head-to-head kind of trial in a prospective way, especially, we had to do it during COVID, so, you know, hopefully, other people don't need to do it, you know, maybe in the next pandemic. And really, even having discussion with the FDA, what's the bar for approvability? Like, for many of these indications, still FDA is thinking, really, how they should think about it.
There was an advisory panel just to advise FDA how they should look at, for instance, think about some of these multi-cancer detection tests. They are in that phase. Versus for CRC, I think, the bar was, "No," in terms of what we need to hit in terms of performance in order to get that regulatory approval. The path was clear for both us and the review team. It was, at the end, 16 months of rigorous review, multiple audits, and going through the advisory panel because this was a first-of-its-kind liquid biopsy with first-line indication that FDA was saying to give us, and coming out with a favorable outcome. So we are very pleased. It's not an easy route, but I think, frankly, it paves the path for liquid biopsy in general.
Now, FDA has a better understanding of what liquid biopsy can do and what they cannot do, and how they should think about it, at least for this specific CRC indication... I think we set the stage and bar of the performance that other tests need to see in this specific indication for future approvals.
What are the learnings from the colorectal journey that you could then apply to your efforts in lung and your eventual efforts in multi-cancer?
I think obviously some is related to communicate early and frequently with FDA. The other learning is you know, try not to do the trial during the COVID. You know, that has its own kind of special challenges. And do it, you know, you know, have bunch of conversation and consortium, right? You know, it's, many of the thinking process by agencies can be impacted, how the whole field, patient advocates, industry, KOLs, think about that field versus just that one specific company that has that pre-sub conversation with agency. So consider that this is this takes the whole village. You need to think big, and you need to really go prepared with a consortium of people, be in agreement with the agenda you're trying to convince FDA with. So, we are very pleased with the great work that our team has done.
With the partnership of, in fact, some of the people that even on this panel, on the consortium work that we've done, is across the whole field of liquid biopsy.
The impact of COVID on the trial, presumably, that is a tough time to run a clinical trial. Did that lengthen the duration of the trial? Did it impact the patient population at all? Just what were the implications of that, which hopefully you won't have to suffer from next time around?
Not in terms of quality, but, you know, keep in mind, when the COVID hit, actually the rate of colonoscopy dropped down significantly as an eligible kind of procedure. So all the enrollment were kind of, you know, it's kind of sudden, kind of a drop. Could we continue this study or not? And kudos to our team. I think our one of the Guardant values is the grit, and there are challenges. You're gonna figure it out. In fact, that COVID challenge happened, we kind of doubled up our effort in cancer screening, and we went from 70 sites to 250 sites to compensate for it. There was another competing trial that COVID started, and they folded their hand.
So that resulted into us finishing this study and getting to this approval probably a year, a year or two before anybody else can even have any kind of submission to agency.
Thinking about current trials and flights, Susan, I, I apologize, I should know this, but Cascade, is that a registrational trial?
That's our FDA trial, and, yeah, please, your question.
Tell me about Cascade?
Yeah, First of all, I agree with everything AmirAli said, and there's a lot to learn from the successful work that Guardant has done. I mean, ultimately, we have a big, you know, hurdle of evidence that all of us need to generate and demonstrate. Physicians are looking for, you know, does this test actually work? Does it provide value to my patients? The FDA, you know, has a responsibility. We really respect that. We, as a small company, we are running 3 clinical trials. So we, you know, it's like the majority of our spend, of our effort, and, so we really believe that, you know, that bar has to be met. We have, an IVD path, so we are, you know, in a Breakthrough Designation with the FDA, modular submission. We've been...
You know, we're well into our journey, very collaborative, you know, discussions with the FDA, very supportive, and, we're, you know, feeling very good about our IVD path. Our major clinical trial for that is Cascade. It's a 12,000 patient trial, a prospective, you know, kind of high quality randomized trial. And, even before that, we have another, clinical trial, similar populations with Europe. I mean, it's for ITLR. We are the only liquid biopsy partner that was chosen for that trial. Now, 9,000 patient trial, kind of in our, patient, population, our intended use population. That trial will read out late this year or early next year and gives us kind of an earlier, you know, trial that will benefit us. And then we're also running a clinical utility study.
The fact that we actually have an LDT on market for lung cancer allows us to do a real-world study that is a blinded, randomized by practice trial, where we show evidence of, you know, higher screening rates by nature of having the liquid biopsy. And so we need to show that not only the screening using liquid biopsy, but also the LDCTs. For those who are found with an elevated result, you know, the kind of subsequent step is to get an LDCT. And then, so we have three, you know, major trials that we're investing in. In addition, you asked about the screening market.
In addition to the IVD pathway, there's the U.S. Preventive Services Task Force, and getting a B rating, A or B rating by the task force means that or all commercial providers, all of Medicaid and all kind of VA systems, so it's 60% of our TAM is actually covered for reimbursement, full reimbursement by law if we get USPSTF B rating. And so we expect that the window of consideration for lung cancer, kind of the five-year timeframe of which they consider these would have considered lung cancer would be next year. And so a lot of our evidence program is, you know, is kind of to be ready for new evidence that's found for lung cancer screening.
And so that's kind of our near-term opportunity for reimbursement, and then the longer term is the, the IVD. That said, I mean, even before reimbursement, this is kind of the role of the LDT. Being out there, getting, you know, getting patients and adoption and improving our test, all those things, LDT gives us a path to do that. We had a case control trial, a high quality case control trial, that's publishing Cancer Discovery that, you know, it was kind of the evidence that we launched our LDT with. And the fact that the cost structure of our test, I mean, we are offering the test at a few hundred dollars.
So there's actually an economic value proposition for health systems to adopt the test immediately, even before reimbursement, and that's allowing us to have some market penetration here as we work towards the full reimbursement path.
I'm sorry, that window of consideration for lung, that opens next year or closes next year-
Next year.
Or both next?
Yeah, we—I mean, in terms of closing, I think that's kind of up to the USPSTF, but.
Okay.
We expect it to-
How long do the windows tend to stay open once they open?
I don't know, historically, kind of what the longest they've been open.
Okay.
But I think it's based on new evidence that's kind of, you know, that appears within kind of their consideration window.
Got it.
And I know Guardant and others are, you know, are advocating for even... 5 years seems like a long time, given, like, the amount of innovation that's happening in the industry for these cancers. So, I know they're. We also advocate for kind of a more timely consideration window.
Well, in fact, with the dense breast challenge, the task force has said they'll open the window early, given the technology and the evidence that gets generated. So they've demonstrated some flexibility depending upon the particular disease state and the evidence.
Huh. AmirAli, will you have your lung data in time for that window?
We'll see. I think 2025 would be an interesting year for us in terms of multi-cancer in general, but we will see, like, you know, we are at the peak of the enrollment of our trial for the lung cancer screening. I think still it's gonna need some kind of work to follow up those patients and get to the readout and... But next year would be a very exciting year. I think there's a lot, you know, confusion in our market just for CRC-
Mm.
that I think we are very calculated talking about multi-cancer, not to generate more confusion, but this is something that we are, like, the vision from beginning, Shield would be a multi-cancer screening device. But we are going at it one, you know, in a systematic and well thought out way, that I think over time, people would figure out this was the right way to open up the multi-cancer screening opportunity.
You know, one of the things I'm tasked with is then, you know, once you have FDA approval, and Susan, once you have FDA approval and et cetera, you know, that's step one, and then I'm sure there are a number of additional dominoes that need to fall as you commercialize your product and grow the market. You know, what are... The only tool I have to model an adoption curve is Cologuard. And what are some of the ways you could try to advance the market more quickly in terms of penetrating your opportunities than what we saw with Cologuard? And Cologuard has been a success story.
I want to make sure I make that clear, but when you think about proportion of its total penetrative market over what period of time, and then we could talk down the whole panel on this. AmirAli, maybe you can start.
Yeah, sure. So, you know, we just launched this Shield IVD now, two weeks ago. We are very excited about it, but we want to be, not get too excited and get ahead of our skis, and at the right time, we would set the expectation for 2025 and beyond. There are some stuff which are good for blood testing. There are some stuff which could like headwinds and tailwinds, so, maybe I can talk about a few. One is market, non-invasive cancer screening market is, much more developed today than 10 years ago, obviously. And kudos to Exact and all the, commercial work that they've done to build the awareness for consumers about the importance of colorectal cancer screening.
Like, we got FDA approval, we got a huge media attention, and like, you know, one of the interesting challenges we are dealing with is, our new reps going to new accounts and a good fraction of doctors know about Shield, versus our plan was they don't know about the Shield. Now, we have to kind of, you know, make some kind of adjustment in our messaging, but it's great kind of issues we are, interesting challenge we are dealing with. So market is more developed. The other side is the unscreened market is much bigger than the people who are getting screened with stool tests. There are 50 million unscreened patient population. What we experienced with Shield LDT is the depth of ordering a physician who got access to Shield was more than the depth of ordering of stool tests on average.
The other thing is, patient adherence is much higher, and it's a pleasant way of cancer screening at the end. Patient adherence translates into, you sell 10 tests, like the SM engine sells 10 tests, more than 9 of them show up in the lab, and you can bill for them. For stool-based testing, 1 out of 3 of the sold cases would never show up in the lab. So there would be some kind of a commercial efficiency that you're gonna get because of high adherence for blood tests. So these are all on a pro, like, a kind of good category. On the other side, we are gonna have more limited sales team right off the bat for this launch.
Like, you know, we are still in the hiring mode, and we are gonna have 100 reps by end of the year to support this launch, and this is commercially promotionally sensitive kind of a brand. The other factor is quality scores. The reality is still CMS has been very progressive, so NCD, before anybody qualifies for it, removing out-of-pocket costs for the follow-up colonoscopy with positive Shield or positive blood testing, that it's a proposed thing. We are hoping to see that finalized in fall. These are all progressive. The part that still is not happening, and probably it's gonna wait till post-guideline recommendation, is HEDIS scores and quality score. So that would be, although we don't reduce quality score, we don't generate incentives for, you know, colorectal cancer screening in terms of Med Advantage payments.
We have to see how all this would play out, but I'm pleased with the initial trend lines of the first two weeks. We see how it goes, and then, you know, when we know more information, we would set the appropriate guidance externally too.
I don't have the two-week volume number for Cologuard, so I can't benchmark you on that. But I'll take your word for it.
That's right.
In maybe just these couple of minutes, any, any of the other panelists want to opine on how to really accelerate? Dave Mullarkey, you look like you want-
Yeah. So, I spent most of my career in therapeutics, and when you look at quick uptakes of new drugs, you know, there's two primary drivers. One is that it works really well. It's better than what's out there, it's effective. And I encourage all of us... The old days, it was good enough, you just get it out, 60% sensitive, whatever the numbers are, you just get it out-
Yeah
'Cause there wasn't really any regulatory approval path to introduce a product to the market. It's really, really incumbent upon us to take that extra time, look at all the innovation and technology and orthogonal inputs we can combine now, to make life easier for physicians to prescribe these tests. The performance will drive higher positive predictive value. This is just a practical thing with doctors: when we say we might see a cancer signal being detected, what percent of the time is there really cancer there? I think if Cologuard, for example, I don't know the uptake and all, but my understanding is it's in the low single digits, kind of PPV, and I'm just using that. NIPT, where I was at last, you know, PPV is 85%. It was a lot easier.
When you gave a positive result, chances are it was positive. And that just saves time, hassle, callback, stressed patients. So we can take that on just by looking at improving the performance the best we can and offering the test in a patient population that has the highest incidence of that particular condition. But the other is, we just... For long-term adoption acceleration, we need to generate data. I mean, we need to invest in evidence generation like you do a new drug. And, you know, it's a real challenge.
A young company like ours, I've completely pulled back on commercialization and are deploying capital into clinical utility, clinical validation, evidence generation, to make sure we're answering the questions that the regulators, that the payers, that the physicians are gonna have, before we just start trying to create some demand and, and end up losing money on every single test. That doesn't, that doesn't help anyone.
So I think it's incumbent upon us to make sure that we can deploy the capital to do that, to help establish the field more soundly, instead of, just kind of getting out with just one data set or two, and then people kind of discount it and say, "Oh, that test doesn't really work that way in the real world." So that's just a key, I think, lesson that just reflecting back in past and what I think for all of us to establish, you know, this particular application more soundly.
Well, maybe we're out of time. Maybe we'll end it on that note. I think that's a call for the capital markets to improve.
Very true.
All right. Thank you, everybody, for joining us today. This was great.