AH060 - A New Approach to Colorectal Cancer (CRC) Screening, with Geneoscopy

Transcript

Lightly edited for clarity.

[00:27] Justin Venneri: Hello and thank you for joining us for this episode of the Astonishing Healthcare Podcast. This is Justin Venneri, your host and Director of Communications at Capital Rx, and we have a special episode for you today.

I'm excited to have Andrew Barnell with us. He's the CEO of Geneoscopy, a startup cancer testing focused company that's expanding its menu currently, and we're going to be talking about what they're up to, and I think it'll be a really interesting discussion for the plan sponsors and our channel partners out there that are interested in new ways to engage members of their plans on wellness and preventive testing.  

Andrew, thanks for joining me today.

[01:02] Andrew Barnell: Justin, thank you for having me.

[01:03] Justin Venneri: So this is a fun one for me because we met a few years ago and I remember seeing some data on your test, ColoSense, and it was kind of a novel approach to screening for colorectal cancer. Andrew, I just want to get right into it. I can't wait to hear the updates.  

Can you give us a little bit about your background, how you and Erica came to found the company? I'd love to hear kind of what you're up to because it looks like you're expanding that test menu as I mentioned.

[01:29] Andrew Barnell: Yeah, absolutely. So my background was in finance. I worked in investment banking and private equity. I have a very talented sister who spends her time doing very different things. She's an MD, PhD by training. She was working in a microbiome lab at Washington University, where much of the microbiome industry was founded. And they developed this really interesting technology to isolate human RNA from stool samples. She felt that that was the perfect platform to develop diagnostic tests for gastrointestinal health, things like colorectal cancer, inflammatory bowel disease, really large unmet needs when it comes to patient health and areas where we don't have great diagnostic tests.  

But we think if we had better diagnostic tests, accurate, easy to do tests, we could really improve both the patient experience and patient outcomes. So that was the idea for the business. She came to me while I was getting my MBA at Wharton and said, we're going to start a business together. So that's what we did. That was about 10 years ago and we've been on this journey to leverage that platform that she helped develop to develop these diagnostic tests for gastrointestinal health.  

In terms of the updates, much of what we've been up to for the past seven, eight years is developing our first test with that platform. That test is called ColoSense. It leverages RNA biomarkers in stool samples and just last year was approved by the FDA as a first line screening test for colorectal cancer and advanced adenoma. So we're in the process of launching that test right now. It's the first of many tests that we expect to be able to bring to patients. But we're really excited to be launching this test and getting more people screened for colorectal cancer.

[02:58] Justin Venneri: And of course, it's Colorectal Cancer Awareness Month, thus the opportunistic nature of this podcast episode. But the test is a little different from other tests on the market, right? You mentioned RNA. Can you just go into that a little bit for the audience?

[03:12] Andrew Barnell: Absolutely. And that gets to our core technology that's proprietary and why it's special.  

So we've learned more about RNA. People probably remember RNA vaccines from the pandemic and the incredible impact that many of those have had, but RNA is a really interesting molecule. So it's derived from DNA. DNA is sort of the cookbook we have in our cells. Every cell has the same two copies of DNA, and when a cell wants to do something, it copies a small piece of it called messenger RNA and encodes for proteins that allow our cells to do things. The challenge that exists with RNA is that it's single stranded, it's fleeting, it can be very hard to isolate and interrogate, especially in a stool sample where we've got lots of bacterial noise and degradation.  

So our technology allows us to stabilize the RNA in a stool sample, transport it back to the lab at ambient temperature, isolate all that bacterial noise and pull out the human signal and then interrogate that RNA. Once you've done that, if you can do that effectively, RNA is very, very powerful. It's quantitative, it's phenotypic, it provides a real-time snapshot of what's going on at the cellular level. And that really provides us this tremendous platform to, we believe, develop the most accurate diagnostic tests for gastrointestinal health. So when we think about our core technology and the capabilities it has to develop tests, that's really what sets us apart.

[04:26] Justin Venneri: Got it. And you just completed a Series C, so congratulations on that. And recently, like more macro wise, I know the recommended age for CRC screening was lowered. I believe it's 45 now, is that correct?

[04:38] Andrew Barnell: Yes.

Related Content

• Multitarget Stool RNA Test for Colorectal Cancer Screening. Barnell EK, Wurtzler EM, La Rocca J, et al. JAMA. 2023;330(18):1760–1768. doi:10.1001/jama.2023.22231
• Pharmacogenomics (PGx) 101: What You Need to Know for Rx Programs

[04:39] Justin Venneri: So you mentioned the tech angle. Do you want to just jump into some of the results you've seen, and you say more accurate screening. What exactly do you mean?

[04:46] Andrew Barnell: Yeah, and maybe I'll start by just helping characterize and describe the need for more screening tests.  

So when we think about colorectal cancer, it's the second deadliest cancer in the country. Over 135,000 people are diagnosed with it every year. 50,000 people die from colorectal cancer every year. But it's also referred to as one of the most preventable cancers. If you can detect it in the precancerous adenoma stage, it is preventable. If you detect it in the early-stage cancer, it is very survivable, and long-term survival rates are very good. But we actually don't do a great job of that. About two-thirds of colorectal cancer are diagnosed in late stage when mortality rates are relatively high and prognosis is quite poor.  

The solution to this is well described. We need to get more people screened, and we need alternatives that are easy for the patient to do and also highly accurate. There's another troubling trend that we often highlight, and this is directly linked to what you mentioned, which is the lowering of the screening age. Colorectal cancer used to be thought of as a disease of older patients. Your incidence rises as you get older. What we've seen over the past two decades is both the incidence and mortality of colorectal cancer is rising significantly in younger patients. We think that has to do with diet, exercise, probably what's in the food we eat. But regardless, the trend is real. And so not only do we need to lower the screening age and encourage people to get screened younger, but we need tools that are effective to screen that population.  

So when we set out to develop our colorectal cancer screening test, we wanted to do all these things. We wanted to develop a test that could be done at home via our stool RNA technology. Really easy for the patient to do, very straightforward. We wanted to develop something that was highly sensitive. We saw in our FDA approval study in average risk patients is that our test detects 93% of all colorectal cancers, including really high sensitivity for colorectal cancer in the earliest stages, when, as I mentioned, it's most treatable. And we saw a sensitivity of 45% for precancerous adenomas, specifically advanced adenomas, which are the most advanced stage of a precancerous lesion before it becomes cancer. So that's a really powerful test that can be used to identify patients that need to go on to diagnostic colonoscopy and get more people screened.  

And we had one of the most robust cohorts that's ever been seen in terms of younger patients. We had several thousand patients in our study that were under the age of 50, sort of that new screening paradigm, and we showed really strong performance in those patients. In our study, we had 100% sensitivity for colorectal cancer in those patients, and 44% sensitivity for advanced adenomas. And so not only can we get people in the traditional screening population screened, but also those younger people that are seeing rising rates of mortality and rising rates of incidence.

[07:23] Justin Venneri: Wow, that's really important. And you brought up the colonoscopy angle, so I'll touch on that in a minute. But I'm curious, and this is sort of a geeky R&D question. Your trial that you ran was, if I remember, decentralized, right? And so you had a pretty good sized trial. Can you tell us a little bit about that? And if you've continued to leverage and evolve that approach? What does that mean for your costs? What does that mean for timelines? And obviously for patients? You know, the data is good. That's great. But how does that experience work?

[07:52] Andrew Barnell: Yeah, we believe we are the first company that's ever run a truly decentralized clinical study for an FDA approval application. What this means is our study did not actually include sites, righ?  The typical way of running a clinical trial is you go to large academic medical centers, and you enroll patients on site. What we did is we found people online, on social media, and in other places. We enrolled them electronically over the phone with nurses and allowed them to go to any physician that they wanted.  

So that had a number of benefits. One, it allowed us to pursue and move forward with the study relatively rapidly. We were able to be very cost effective. But maybe most importantly, I think we ended up with one of the most representative patient populations that's been seen in the study, and that includes from an income perspective, from a racial, from an ethnic perspective, from a geographic perspective. We had a very large number of people in rural areas that typically don't have access to clinical trials because they're not in those urban suburban areas where you have those academic medical institutions.  

So what that meant is, one, we believe that the trial data is extremely representative and will be exactly what we see in the clinic. And also, I think, it gave us a capability to reach patients. You know, a lot of what we intend to do commercially is telehealth, getting kits to people at home, even if they might not have a primary care physician, working with insurers, working with employer-sponsored plans.  

There's a lot of opportunity to meet patients where they are. Especially when you think about a 100-million-person screening population, people are going to have different perspectives, needs, views, wants, and I think you need to have the flexibility to deliver a screening option that works for everyone. And the use of technology, something like what we did for decentralized clinical studies, is going to be one of the tools in our tool bag to help achieve that.

[09:36] Justin Venneri: It's very cool. I recall reading on it, I was like, wow, this is really intuitive. And especially given varying access to technology and bandwidth and all that good stuff that goes along with that, like how do you get in touch with people where they are -- that makes a ton of sense.  

So patients in general, you brought up colonoscopy, updated guidance, updated screening options. This is kind of a sticking point sometimes where it's, you know, colonoscopy versus test and whether it's screening or diagnostic tool, right? Is that still an issue? And how have you been able to work through that? Or how have you seen people become more comfortable or whether it's an insured benefit or whether it's out of pocket. How do you see people dealing with this? And if you can take a step back and explain that so people understand what I'm asking would be helpful too.

[10:20] Andrew Barnell: Yeah, absolutely. So colonoscopy still remains the gold standard. And one of the benefits of a colonoscopy is that it is both a screening test and a diagnostic procedure. You can both identify lesions or cancer and simultaneously in most cases, unless you require surgery, remove them. And in the United States, historically we've screened with colonoscopy. At the same time. Colonoscopy has limitations. It's time consuming, expensive, it's invasive. Patients don't like the prep. And so what we've seen in the United States is a very large percentage, about 40%, of people don't want to do a colonoscopy and simply don't get screened. And that's where you see this dynamic of people getting diagnosed in late stage because they're finding out they have colorectal cancer when they show up in the emergency room with symptoms.  

And so the solution there for non-invasive tests is that for those 40% or more of patients that don't want to get screened via colonoscopy, they can get screened with a sensitive, at-home, easy-to-use test and then the small percentage of patients that have a positive on the non-invasive test are then referred to a diagnostic colonoscopy. And what we've seen is once you know that you're high risk, you know, if you know that you have a positive on a non-invasive test, it's important to provide the navigation, the education, that you need a colonoscopy. But those patients are much more likely to go onto the diagnostic colonoscopy. And that's how we sort of close the screening loop and help drive up colorectal cancer screening compliance rates.

[11:41] Justin Venneri: Overall, do you see an improvement out there in terms of an understanding about this dynamic, screening versus diagnostic tests and the cadence there, that kind of process? How much more education do you think is required to improve that percentage of the population that's getting screened at appropriate times?

[11:58] Andrew Barnell: I do think the awareness is growing, but at the same time, 30% to 40% of people still aren't getting screened.

[12:04] Justin Venneri: Yeah.

[12:04] Andrew Barnell: Now some of that has to do with changing guidelines. The patient population that is the least screened today is the 45 to 49 population. Only about 20% of that patient population is screened. And part of that is we just changed the guidelines a few years ago. So, it's a constant project to make sure people are educated.  

But it goes beyond that. You know, they need to have insurance, they need to understand the out-of-pocket implications, they need to understand how to get the screening tests. And so there's a lot to do, but the education component of it is critical, and that's something that we think we can play a role with.  

One of the things that we're really excited about, one of our distribution channels is through our partnership with LabCorp. LabCorp has tremendous reach. Whether that's geographic reach, whether that's reach into health systems and hospitals. We think that partnership will allow us to reach patients that are not engaged with screening today and ultimately achieve that goal of what we've been talking about, which is increasing screening compliance rates.

[12:58] Justin Venneri: Got it. And this might be sort of a 101-level question, but there can be a pharmacy component of colonoscopy, correct?

[13:04] Andrew Barnell: Absolutely.

[13:05] Justin Venneri: So like the OTC option, a powder that we all know what it's for, and mixed with Gatorade zero or something, versus an actual prescription for the prep, and then it's an at-home kit. Is that just in general medical or prescription pharmacy benefits? Do people pay out of pocket for the prep? Can you talk a little bit about the dynamic for the actual patient going through this and what they're paying and how they're paying for it?

[13:26] Andrew Barnell: Yeah, absolutely. There has been a big push. I don't think the gap has been fully closed at this point, but there has been a big push to make sure that preventive screening procedures have no patient out-of-pocket costs.  

I think we've gotten there in a lot of ways. One of the most recent loopholes that was closed was we've been pushing non-invasive tests, but oftentimes if you did a non-invasive test and then you went on to the diagnostic colonoscopy, well, then the patient got hit with a bill. The United States Preventive Services Task Force and the Affordable Care Act have mandated no patient out-of-pocket cost for tests that are in the guidelines and FDA approved. And so I think we've done a good job of eliminating cost as a barrier to patients getting screened.  

But what I would say, as we've gotten more patients screened, the cost for PBMs and health plans has definitely gone up. When we think about non-invasive molecular tests, one of the largest spends that many PBMs and insurers see now is colorectal cancer screening. One of the things we believe about our test is it is incredibly cost-effective. There are a lot of different options that have different accuracy profiles and different costs, but when we look at ours, we think ours is incredibly cost-effective. And not only do we think it's one that we can help these groups improve outcomes, but we think we can help them manage their costs.

[14:39] Justin Venneri: And what is that cost profile or what would someone expect the cost to be for ColoSense?

[14:44] Andrew Barnell: So our test was recently priced by Medicare and it's $509 per test.

[14:49] Justin Venneri: Cool. I remember the emergence of and rapid growth of high deductible health plans. Is that perception of the cost associated with the screening test? I think I recall in the late 2000s, so like 2008, 2009-ish, we saw this drop in screening, and it was largely attributable to the growth of HDHPs and people thinking they had a lot out of pocket to cover it. And obviously with the ACA and high deductible health plans have become more prevalent in the market.

Is that still an aspect of the friction in the market in terms of getting people screened from the insured population, or is there something else going on there with wellness programs?  

I guess asked a different way, like what advice or suggestions do you have for plan sponsors or administrators regarding expanding or improving engagement and helping drive participation in programs for screening in their populations?

[15:38] Andrew Barnell: There's no shortage of barriers. I would say when I think about today, I think cost for the patient is definitely one, but I think others are probably bigger.

I think one of the biggest ones is just easy to do: for the patient to be able to get a test at home for the instructions and the steps the patient needs to take to be incredibly straightforward. And I'll share one other statistic that we think is really powerful and it's one of the things that's leading us to partner with some of the employers that we are. We have seen data that patients or employees are significantly more likely to get screening done when it's promoted and encouraged by their employer. So sometimes it comes down to just who it's coming from and how it's being encouraged and how you're being educated on it.  

And one of the ways that we see to really make progress there is to engage employers in active programs to support screening. And what we know and what we've seen in the data is that that by itself will help drive up screening compliance. And you're going to see the benefit in terms of a healthier patient population and reduced costs through a reduction in colorectal cancer diagnoses and associated late-stage treatment costs.

[16:44] Justin Venneri: Have you seen any data on the reduced costs down the line of screening? I think there may be studies on that. Is there anything I could link in the show notes for people or anything you'd highlight?

[16:52] Andrew Barnell: There absolutely are. We can get you some papers on that. We've got a number of different materials that you can share. Some of them have to do with just showing, one, the reduction in mortality when you screen and catch things early, the reduction in treatment cost when you screen and catch stage early. But we've got all sorts of that stuff and we can definitely send you that to link to.

[17:09] Justin Venneri: That'd be amazing. Thank you. So I've got two more questions for you. Andrew, thanks so much for joining me this morning. I know you're busy. Anything you'd like to add or what else should I have asked you about CRC testing and the expansion of your testing capabilities? You mentioned moving into other GI. Is that inflammatory? Other?

[17:24] Andrew Barnell: Yeah. I'll touch on our pipeline a little bit. I hit on this at the top of the show, but there are so many unmet needs within gastrointestinal health. We've talked a little bit about colorectal cancer, but inflammatory bowel disease is a big one.  

Inflammatory bowel disease consists of Crohn's and ulcerative colitis. There are about 3 million people living in the United States with Crohn's and ulcerative colitis. And we really don't have good diagnostic tools to help these patients manage this chronic condition. Whether it's non-invasive tests to help assess disease activity, whether it's diagnosing patients, whether it's helping patients identify if they have a high-risk condition like stricturing or might be about to flare, or maybe one of the biggest opportunities, which is finding the right therapeutic for the right patient based on that patient's genetic profile or the expression of the inflammation that they're experiencing at that time, there's really nothing to help patients there.  

And so we're working on that. We see a lot of opportunity to use our platform of stool RNA to address those conditions. We're working on a lot of clinical trials with pharma and we're so excited about the potential we see there to impact patients.  

And beyond that, there's other opportunities as well. Celiac disease, familial adenomatous polyposis, hereditary CRC, other things. There's so many things we can do within gastrointestinal health and we just really think we're at the tip of the iceberg in terms of the impact we can have on patients.

[18:44] Justin Venneri: Yeah, it's super exciting to hear about it and I'm impressed by the pronunciation of all of these conditions. And I know that's challenging being on the PBM side of things. A lot of us that are not pharmacists, we're always like, forgive us if we mispronounce this, but you're, you're nailing them.  

Last question for you today, and I ask everyone, what's the most astonishing or surprising and interesting thing that you've experienced since you've launched Geneoscopy that's safe and compliant to share, of course? I'm sure you've seen a ton of stuff along the way that's amazing in good and bad ways. Just tell us a good story.

[19:11] Andrew Barnell: Yeah. Maybe two things pop to mind for me. The first, people would be surprised the things that patients will do with an at-home collected sample. It speaks to the importance of clear and easy to follow instructions. But sometimes even we are surprised with some of the things that end up making their way back to our laboratory. So.

[19:33] Justin Venneri: Okay, I will not dig on that one.

[19:35] Andrew Barnell: [Laughs] Yeah, I was going to stop there. I wasn't going to share more detail on that.  

But then maybe the second one, this is one that's definitely surprised me. I think when people think about heavily regulated life sciences companies like ours, there's this big focus on FDA and how long it takes to get through the FDA and how much capital it takes. And that's real. I think what many people don't often realize is, in some ways the FDA approval is just the beginning of the journey in terms of the regulatory pathway you have to go through.  

After FDA approval, especially in diagnostics, you have additional organizations like Medicare coverage, where until you have Medicare coverage, most commercial insurers won't pay for you. And then you have guidelines, like the U.S. Preventive Services Task Force, that are updated by the government very rarely. And until those guidelines are updated, your tests might not be included in quality metrics. And then physicians are disincentivized from ordering it. So there are a lot of barriers to innovation getting into the hands of patients. And in many ways FDA and demonstrating your test is safe and effective in a 10,000-patient study and going through all that is not even the biggest one.  

So one of the things that we're big advocates for is streamlining the path for innovation to get into the hands of patients because there's so much opportunity to improve patient care, lower costs. Sometimes we need to make sure we're not getting in our own way. And that's one of the things that we are really advocating for.

[20:57] Justin Venneri: We here at Capital Rx would completely agree with that. There are definitely opportunities to streamline things and improve workflows and reduce timelines and get things that are going to be helpful to the broader population to market more quickly.  

One thing just occurred to me as you were speaking, based on what you said earlier about working with pharma, does it help? And forgive me if this is not what you were saying, but if you're working in tandem with pharma on something and you have the data from the patient and sort of a pharmacogenomic angle, and you're tying it out to say, hey, this patient's condition appears to be based on this marker, and this drug has better performance for patients with that marker, is that what you're doing and kind of tying things together there, and then does that kind of partnership and bringing something to market help accelerate that timeline?

[21:42] Andrew Barnell: It's one of the things we're working on, which we would call those companion diagnostics, one of the things we always highlight, and this is probably also quite relevant for your pharmacies, but there's 14 approved drugs for inflammatory bowel disease, and we have no way to pick the right one for the right patient. And some of those are very expensive. So, if you can use our test, understand the flare and the type of IBD that that patient is experiencing, and you can get them the drug that targets the pathway that's upregulated, that gets you to the right drug the first time, as opposed to failing three or four, that's gonna be a huge benefit, both in terms of the patient and the cost.  

And so those are the types of things that we see. We've been doing that in oncology for years, and inflammatory bowel disease, it doesn't exist. So, one of the things we're doing, exactly as you were highlighting, is bringing precision medicine to other conditions outside of oncology where they're desperately needed, like an autoimmune condition like inflammatory bowel disease.

[22:38] Justin Venneri: Andrew, thank you so much for joining me this morning. I really appreciate you taking the time to chat with us here and look forward to following your story and hopefully have you and Erica back on to talk about your success in the future.

[22:50] Andrew Barnell: Thanks, Justin. Appreciate you having me.

Reference Materials/Other Links (courtesy of Geneoscopy)

• Projected Impact and Cost-Effectiveness of Novel Molecular Blood-Based or Stool-Based Screening Tests for Colorectal Cancer. Ladabaum U, Mannalithara A, Schoen RE, Dominitz JA, Lieberman D. Ann Intern Med. 2024 Dec;177(12):1610-1620. doi: 10.7326/ANNALS-24-00910. Epub 2024 Oct 29. PMID: 39467291.
• Colorectal Cancer—Patient Version. National Cancer Institute (NCI)
• Productivity savings from colorectal cancer prevention and control strategies. Bradley CJ, Lansdorp-Vogelaar I, Yabroff KR, Dahman B, Mariotto A, Feuer EJ, Brown ML. Am J Prev Med. 2011 Aug;41(2):e5-e14. doi: 10.1016/j.amepre.2011.04.008. PMID: 21767717; PMCID: PMC3139918.
• Follow Geneoscopy on LinkedIn

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