18 Sep 2020
Author: WP Dev
17 Sep 2020
CMS soon to cover a new colon cancer DNA test. Plus, 10 takeaways on the first and only FDA approved liquid biopsy test.
Epigenomics is a liquid biopsy company listed on the Frankfurt Stock Exchange. Epi proColon detects colon cancer through a specific DNA called Septin9 (altered in colorectal cancer tumor cells). The company expects CMS approval anytime now and is due to launch nationwide in US this year.
These takeaways are based on their Q2 2020 Earnings Call. Frederic Hilke, the Investor Relations Manager for Epigenomics, and Greg Hamilton, the CEO of Epigenomics AG made these remarks.
1. The operational highlights for Epigenomics include:
◘ CMS’ initiation of the National Coverage Determination (NDC) process for Epi proColon in late February.
◘ Inclusion of Epi proColon in the 2020 NCCN guidelines.
◘ Publication in the Journal of the National Cancer Institute (JNCI) which concludes that Epi proColon is the test of choice for patients who are not willing to participate in FIT or colonoscopy screening.
2. Epigenomics believe that the test is necessary as there are an estimated 9 million Medicare beneficiaries who are not willing to participate in FIT or colonoscopy screening.
3. They believe that as the only FDA-approved blood-based test available, Epi proColon has the opportunity to save over 225,000 Medicare lives.
4. Epigenomics also reckoned that the annual Epi proColon testing was found to be clinically more effective than Cologuard (every 3 years) and (annual) FIT testing.
5. The company indicated that it is interesting to note the clinical benefits of Septin9 (Epi proColon) testing vs. an annual stool DNA test.
◘ Despite 92% sensitivity versus 68% sensitivity, the incidence of Colorectal Cancer is nearly identical, and the mortality is equivalent between the two tests.
◘ The implication of this is that even if future blood tests have increased sensitivity, their impact to clinical outcomes will be negligible.
6. The company feels that nearly all future blood-based test and development are going to be next-generation sequencing-based.
7. The company reckoned that annual stool DNA testing is extremely cost-ineffective. Which is why Epigenomics believes that Epi proColon is well-positioned to be the test of choice for an extended period of time.
8. The revenue for Epigenomics in the first half of 2020 was EUR 322,000. According to the company, the decrease between the first half of 2019 and 2020 was due to the effects of COVID-19 during Q2.
9. They feel that there is significant growth potential in 2021. Gregory Hamilton, Epigenomics AG – CEO & Member of the Executive Board commented, “I mean if you just think of the unscreened market alone, there’s 35 million patients who haven’t been screened.”
10. Post reimbursement, one of the key projects that the company is set to work on is expanding the label of Epi proColon from 50 to 75.
Note: The company feels that CMS will issue a positive coverage determination. As Epi proColon has met the required standards and now with the publication in JNCI, there is a published peer-reviewed evidence that Epi proColon is cost-effective and the test of choice for patients unwilling to participate in FIT or colonoscopy screening.
Edited Transcript of ECXn.DE earnings conference call or presentation
Epigenomics Annual Report 2019
Epigenomics AG: CMS Still Actively Working On Proposed Decision Memo with Goal to Publish As Soon As Possible
1) What has colon cancer screening got to do with self-driving cars?
2) Exact Sciences: COVID-19 will accelerate the adoption of Cologuard by one to two years toward ‘40% market share’ goal
3) 20 Takeaways from Exact Sciences call: “Cologuard fits seamlessly into a permanently changed healthcare environment”
COVID-19: The Way Forward for Gastroenterology Practices
COVID-19 is a double whammy of both clinical and business disruption. This ebook will help you explore possible scenarios and be a guide in your plans for the future.
11 Sep 2020
Interview with Dr. Fourment, CEO of Precision Research: “Clinical research will be very different in five years”
Christopher Fourment, M.D is the President and CEO of Clinical Research Strategy Group and Precision Research (Texas).
In this interview, you’ll learn why Dr. Fourment chose to focus on clinical research as a career path. Dr. Fourment also walks us through the various aspects involved in clinical research and how CRSG and Precision Research are helping GI physicians build a sustainable ancillary for their practice. He also reflects on the role of the future of clinical research in a digital world.
Watch this insightful interview in full to learn what it takes to create a clinical trials ancillary in gastroenterology (14+min).
◘ The difference between CRSG and Precision Research
◘ “We do a lot of the heavy-lifting which allows the sites to do what they do best”
◘ How and why Dr. Fourment built a career focused on research
◘ “Doing research as an ancillary helps everyone”
◘ “…an average patient visit generating $1,700 to $1,800 per visit”
◘ Profitability in clinical research
◘ Steps practices can take to engage with CRSG and Precision Research
◘ Playing the role of a co-director
◘ “The end goal is that I want to build research in their practice that is sustainable for them (the practice)”
◘ What GI research is getting sponsored right now
◘ “The research landscape in five years is going to be very different”
The Transcribed Interview:
Praveen Suthrum: Dr. Chris Fourment, thank you so much for joining me in today for this conversation on clinical research. You are the President and CEO of Clinical Research Strategy Group as well as Precision Research. So glad that we’re speaking finally and happy to get started.
Dr. Chris Fourment: Thanks for having me on, Praveen.
Praveen Suthrum: I wanted to start by asking you that what is the difference between the two companies that you run, CRSG and Precision Research?
Dr. Chris Fourment: It’s kind of how they conduct business is the main difference. So, for Clinical Research Strategy Group, the customers for CRSG are – one site that really wants to build research but doesn’t know how to get started. Doesn’t want to take the time to build or to figure out how to build infrastructure. The second customer for CRSG is the site that is already built and already running research but maybe wants to take it to the next level whether it’s just increasing profitability, increasing the geographic size, and scalability. But the key with that group is to really provide to groups that want to do good research the tools to build the infrastructure and allow them to be sustainable long-term on their own.
With Precision research, it is called a Centrally Integrated Research Network or CIRN and what this is… it is a network of really good GI clinical research sites around the country, who have shown a lot of performance in the past, who already do good research, and what Precision does is… it contracts with pharmaceutical companies to bring studies and once we bring the study to the research network, then we handle a lot of the pain points for the sites. We handle a lot of things like the startup, we handle the contracting, and all the budgeting, the regulatory for instance is all done for them. We build out the source documentation we build out the study in the CTMS – Clinical Trials Management System. So, we do a lot of the heavy-lifting, which allows the sites that are part of Precision to do what they do the best… which is to identify patients for trials, and get them in and see the patients.
Praveen Suthrum: How did you personally choose to focus on clinical research versus doing what everybody does – either going into private practice or academic medicine?
Dr. Chris Fourment: Yeah. Great question. So, after medical school, I got an offer from a pharmaceutical company to come into their medical affairs division. And I worked there for seven years in IBD at the pharmaceutical level as a medical science liaison and then a liaison between clinical operations and medical affairs. One of the things that it allowed me to do is see a bunch of clinical research happening across the country. And I saw sites both academic and community practice and worked with those sites in clinical trials. And what I noticed was there were a lot of sites that were probably destined for failure in the next five years. In other words, the burden of doing research at their site was becoming so much that they weren’t going to be able to kind of keep it going. And because of the burden and because of the pull of their regular practice, the doctors were probably at some point going to have to make a choice and decide whether or not they wanted to devote more time to this research effort. Or whether they just wanted to continue their practice.
I then went to work for TDDC in the GI Alliance and worked with a great partner, Dr. Tim Ritter over there. Where we for five years, built that program to one of the premier clinical research programs in the US. And after that, I really decided to continue to do what I think I love doing which is helping sites become really good. Whether or not it is going to be a true ancillary for the practice or whether they just want to improve the clinical resource or be able to offer clinical research to patients.
Praveen Suthrum: Why should GI practices consider research as an ancillary?
Dr. Chris Fourment: Reasons to… I think to do research as an ancillary or to create an ancillary out of it is that it helps everyone. You look at it from the patient’s standpoint, the patients have access to those therapeutic advancements that most won’t have access to for the next 10 years and they have access to them today through clinical research. So, it is a great way to bring those things to the patient sooner. It is a great way to be able to see the patient more. You take IBD as an example; I think all of us believe that in the ideal world we would be able to see our patients sooner than let’s say six months for a visit. And with clinical research, you are able to do that. You are able to see your patience on a graduated scale to make sure that their disease is being aided by the approach that you’re using.
To the practice, to our point, it can certainly be an ancillary. We look at these research visits, and I think ideal to me in my mind is an average patient visit in research generating around $1700 to $1800 per visit. And a coordinator… when I look at how many visits a coordinator ought to have over the course of a month generally speaking what rate looks like to me is somewhere between 20 to 30. So, if you multiply, let’s say 20 visits by about $1800 per visit you can see that if you have the patients in your practice, and you bring research into the practice, it doesn’t take long to really grow into a point where it can become a good ancillary.
So, that’s the direct value for the practice. The indirect value is that not every practice has research going on. And so the way you’re viewed in the community if you have a research program going on at your clinic may be much different than the gastroenterology practice down the street and that could impact things like referrals. As you get referrals from the primary care. That could impact the way the patients sort of view your practice (if you have research). And then the last part is profit. So, if it helps the patient, if it helps the practice, does it help the bottom line? And you know the way that research runs in a lot of cases in practice is it is kind of a break-even type of prospect. But there’s a way to… And a method to really make research become profitable. So, if you like the first two pieces, if you believe that it helps the patient, if you believe that it helps both, directly and indirectly, the practice, there is a way to get profitability.
Praveen Suthrum: Now, when a practice decides to engage you or work with you, what are the exact steps that they can take?
Dr. Chris Fourment: Well, it depends. In Clinical Research Strategy Group, I mean the best thing to do is reach out. And then, what Clinical Research Strategy Group will do is take a look at where the research is currently in the practice. So, in other words, do they already have a foundation for research? Or are we building a research from scratch? And either one is okay but there are different strategies that go into both of those. One of the things that we rely on heavily is a Clinical Trials Management System. It is sort of like an EMR for research and it allows a lot of transparency into the program. It also allows us to draw metrics on the program.
The other things that we do to get started are – we create as SOPs – standard operating procedures that represent what our sponsors want to see out of the research, and what the FDA wants to see out of the research. We create a corrective and preventative action plan or a CAPA plan. A CAPA plan is what we use when something goes wrong in research and we have a protocol deviation to make sure it doesn’t happen again. The other thing we do is start to establish a budget for the sites based on upon the actual value of the time that they will spend in studies. And we put together the justification letter so that when the sponsor comes back, and says “Well we can’t really give you X number for this particular procedure” you say, “Hey look that’s my policy here at the site.”
With Precision, again we’re looking for sites that already have good research programs going on; they are already doing fantastic research. And what they can do is getting contact, if they have it already and we can look at sort of what that model would look like for them. And the types of studies and studies that we have to offer, that we could bring in, with full Precision services. And we do that at no charge with Precision. So, the sponsor pays us. The site does not. But again, they need to have the CTMS system in place. That is the most important piece because that allows us in the Precision model to be able to build the regulatory file for them, and manage that regulatory file. It allows us to build the source documentation so that they don’t have to (that’s about a 10-hour job for a coordinator). It allows us to build the study into the CTMS system properly to make sure that they are able to run the reports and go through the financial aspects that they need.
Praveen Suthrum: What is your business model in both these companies? How do they pay you? Like, the way you have narrated CRSG seems to be more of a consulting angle, and Precision maybe a little bit different. If you can clarify that, I think it will be helpful for practices to know.
Dr. Chris Fourment: You’re exactly right. So, CRSG is more of a consulting model. The role that we play at the site is more of a co-directorship, right? So, we really partner with that site. And I’m on calls multiple times a week with each of the sites that we work with to make sure that things are going in the right direction. Once you are in the Precision network, short of the cost of the CTMS system, which is nominal…, it is a few $100 a month or something. So, that is the only cost to the site.
Praveen Suthrum: What kind of a budget should they outline? And when they work with you, does it involve costs associated with building a site, if they don’t have one because it requires space.
Dr. Chris Fourment: It’s a great question. So, there is a cost involved obviously, as with any other ancillary. If you build an infusion center, you are going to have to buy infusion pumps, you’re going to have to buy chairs, and you’re going to have to do all that. So, the equipment cost… what you need to do research – refrigerators, freezers, the centrifuge, things like that. The cost for all those is around $15,000 per site. If you want to do multiple sites, it is going to be sort of amplified there. Again, the cost of the CTMS system is nominal. And it is important to do it individually. So, rather than having just… sort of one-size-fits-all program, we’re able to look at what the site’s needs are, and what the site’s desires are.
Praveen Suthrum: So, I’m guessing it depends on contract to contract?
Dr. Chris Fourment: Absolutely it does. But you know, the end result or the end goal is that I want to build research in their practice that is sustainable for them. There are a lot of other models and things like that… that would build research in the practice and continue to take it and give the practice a little bit. I want to be able to have this be a sustainable ancillary for the practice.
Praveen Suthrum: What kind of research in GI is going on with the sponsors that you are connected with?
Dr. Chris Fourment: So, there’s a lot of IBD research. Crohn’s and Ulcerative colitis in both phase two and phase three. Phase two is the shorter-term studies and phase three are the longer-term studies. There’s also work on the luminal side in Eosinophilic esophagitis (EoE) and celiac disease and many others. On the hepatology side, there are NASH trials. I think it is a great idea to sort of broaden out our scope and take on IBD studies and also NASH trials. There’s a lot of work going on in both of those spaces and should one sort of ebb and flow, the other one will perhaps be the opposite. In other words, if we cure Inflammatory Bowel Disease, which would be wonderful, then you still have a productive NASH program going on.
Praveen Suthrum: One final question Chris on technology and clinical research. There seems to be a big role for artificial intelligence and more advanced technology in clinical research. Could you share your thoughts on that?
Dr. Chris Fourment: So, one of the things that COVID has taught us and it was actually a conversation going on prior to COVID was – could we sort of build virtual clinical research? So, could we reach more patients by having a virtual clinical research platform so that we can do informed consents online or via telemedicine, something like that? Could we conduct a visit virtually? So, that’s one side of that. A company that does a great job of that is Rx.Health, with the trial-engage platform they are working on exactly that. Another piece of that puzzle – How do we get patients for our studies easier? So, how do we identify those patients that already exist in our EMR system, without having to do it completely manually? And a company called DAYCAP is invested in that space and really working hard as is Rx.Health. So, I think there are a number of different options that if we look at the research landscape in five years, I think it’s going to be very different. I think all of the aspects of clinical research are not going to be held in a brick and mortar office, I think many of them will be done virtually.
Praveen Suthrum: Thank you very much for all the insights and perspectives. It’s definitely very educational for me and I’m sure it’ll be the same for everybody who’s watching it.
Dr. Chris Fourment: It was a great discussion this morning. So, I appreciate you for having me on and I appreciate all that you’re doing.
Praveen Suthrum: Thank you so much.
By Praveen Suthrum, President & Co-Founder, NextServices.
COVID-19: The Way Forward for Gastroenterology Practices
COVID-19 is a double whammy of both clinical and business disruption. This ebook will help you explore possible scenarios and be a guide in your plans for the future.
11 Sep 2020
Curated GI articles Sept 9th, 2020: Google quietly announces AI algorithm for colonoscopy screening + more
Curated GI articles Sept 9th, 2020:
Google quietly announces AI algorithm for colonoscopy screening + more
Chadwick Boseman’s death shed a much needed light on colorectal cancer (CNN)
African Americans also must recognize their elevated risk. Incidence of colorectal cancer is 20% higher in Blacks than in Whites, and Blacks are 40% more likely to die from the disease than Whites.
Video: Interview with GB Pratt, CEO of ModifyHealth: We are a 100% aligned to where healthcare is heading (NextServices)
In this interview, you’ll learn more about ModifyHealth’s business model. A big question GB reflects on is whether ModifyHealth goes against the grain of today’s healthcare model.
Google quietly announces AI for colonoscopy screening (Google AI Blog)
“The C2D2 algorithm promises to lead to the discovery of more adenomas, thereby increasing the ADR.”
What has colon cancer screening got to do with self-driving cars? (KevinMD)
Read an excerpt from the first chapter of Scope Forward: The Future of Gastroenterology Is Now in Your Hands.
Tools Emerging to Predict Liver Failure in Cirrhosis (Medscape)
“Before this, we never had any patient signatures to identify ACLF,” said Jonel Trebicka, MD, PhD, from the University of Frankfurt in Germany.
Baseline Disease Activity and Steroid Therapy Stratify Risk of COVID-19 in Patients with Inflammatory Bowel Disease (NCBI)
Study on COVID-19 patients with/without IBD. Lukin, Kumar, Hajifathalian, Sharaiha, Scherl and Longman.
7 Recent reports in interventional endoscopy (Healio)
Recent developments on balloon-assisted enteroscopy, state of endoscopic education and reopening their endoscopy centers in the wake of the COVID-19.
ASGE launches campaign to promote safe colonoscopy screening (Becker’s GI & Endoscopy)
The American Society for Gastrointestinal Endoscopy launched its “Value of Colonoscopy” campaign to remind patients about the importance of regular preventative screenings.
The Battle Against Growing Burden of “Silent” Liver Disease Begins with Early Detection (HCPLive)
NAFLD is gaining more attention as a chronic medical condition, affecting approximately 25% of the worldwide population and 100 million individuals in the United States.
AGA recommends bidirectional endoscopy for most patients with iron deficiency anemia (AGA)
New AGA guideline outlines steps for early GI evaluation, which can lead to the identification and treatment of underlying digestive conditions.
5 most-read stories in GI this week — A spotlight on early-onset CRC & more (Becker’s GI & Endoscopy News)
Here are the five most-read Becker’s ASC Review articles for gastroenterologists.
Why Walmart Health’s chief just left the ‘dream job’ to lead a testing company you’ve never heard of (Fierce Healthcare)
“BioIQ is sitting here with nearly 500,000 COVID test capacity per day.”
Video: Gastro Ex: Video Game for Gastroenterologists (Level Ex)
Perform surgical procedures on virtual patients, diagnose diseases and conditions of the gastrointestinal (GI) tract, and earn CME with this video game!
Who’s Better Off: Employed or Self-Employed Physicians? (Medscape)
Self-employed physicians have the highest salaries, largest homes, and greatest wealth – yet they feel the least fairly compensated, according to an analysis of data from over 17,000 physicians.
Headlines for GI
The Regueiro Report: From the Virtual ECCO 2020 (Gastroenterology & Endoscopy News)
The future of gastroenterology and other excerpts on industry-changing trends (Becker’s GI & Endoscopy)
Telehealth and the new choreography of ‘anywhere care’ (RamaOnHealthcare)
Many Advanced Countries Missing Targets for HCV Elimination (Medscape)
Probiotics Reduce Mortality and Morbidity in Preterm, Low-Birth-Weight Infants (AGA)
NASHNET Announces the Publication of a Cost-Effectiveness Analysis Study in the Leading Journal “Gastroenterology “ (PR Newswire)
Older With IBD: Long-Term Outcomes After IPAA (Gastroenterology & Endoscopy News)