EPI Übernahme - Wir halten zusammen

Hier ist mal wieder eine Euphorie auf dem Board. Dabei hat Greg doch gar nichts wirklich Neues erzählt. Mal abgesehen von der möglichen Verdreifachung des Kurses am Ende des Webinars.

Wer’s nicht glaubt, kann in den folgenden Posts nochmal nachlesen. Ich habe das Transkript aus dem Youtubevideo gezogen und überarbeitet. Das Video findet man hier: https://www.youtube.com/watch?v=i9j5s8WRb_M
Den größten Teil der „you know“, „in essence“ und andere Wiederholungen habe ich dabei für die Leseverständlichkeit raus genommen. An wenigen Stellen habe ich auch umgeschrieben. Wer ganz sicher gehen will, was wirklich gesagt wurde, muss selbst reinhören.

Krass fand ich wie oft bestimmte Redewendungen oder Worte immer wieder wiederholt wurden. Das ist mir früher nie so aufgefallen. Das Wort ultimately kam z.B. mind. 27 Mal vor. „In essence“ trotz des Rauskürzen immer noch 17 Mal.

Ich drücke allen die Daumen, dass die Erstattungsentscheidung der CMS positiv ausfällt. Aber es würde mich auch nicht überraschen, wenn es nicht so kommt. Denn bisher hat ja noch nie etwas im ersten Anlauf geklappt.

Bleibt gesund.

MfG J:)E

 

29.07.2020 233 Aufrufe -- Encode Ideas, L.P. hosted a Virtual 1x1 Webinar with Epigenomics AG (ECX.DE, EPGNF) senior management; Greg Hamilton, CEO, and Jorge Garces, PhD, President and Chief Scientific Officer, on Tuesday July 28th at  AM ET. Encode discussed Epi-procolon, the colorectal cancer screening market, and dived into Q&A from investors.
For more information on Epigenomics please visttwww.epigenomics.com/
For more information on Encode Ideas, LP please visttencodelp.com/
HOGAN MALALI (Encode):  Okay, good morning everyone I guess good afternoon for those of you dialing in from overseas I know Epigenomics has a a big following in germany so we've got some people from germany calling in. My name is Hogan Malali. I'm one of the founding partners of encode ideas we're excited to be having our first webinar of what we hope will be a series of webinars with companies that we cover or have an interest in.
We were really pleased to have Epigenomics as our first company to join us. Amongst our coverage universe, this is the company that has the biggest milestone and the nearest term milestone on its horizon. So i'd like to thank Greg Hamilton and Jorge Garcia of Epigenomics for joining us and agreeing to be our first company for this webinar series.
We initiated coverage on Epigenomics in June. And I have to say the the investor feedback we've received has been has been remarkable. We've had tons of positive interactions with investors on our investment thesis here. I'd like to thank both Greg and Jorge for making themselves readily available for a number of one-on-one calls. We're pleased to see the stock behaving really well so it's been a really positive launch for us and something that we think will be continue with that sort of positive trend, as we head into this sort of massive inflection point for the company, which is the August 28th preliminary CMS reimbursement decision.
Before I turn over to Greg and Jorge to introduce themselves just from a sort of disclosure perspective i'd like to to highlight the fact that the partners of Encode Ideas do own stock and Epigenomics to purchase that stock in the open market we have not received compensation for our research nor have we received compensation for hosting this webinar. We do stand to potentially earn compensation from Epigenomics in the future. And with that I'd like to turn it over to Greg and Jorge if they could each introduce themselves. Maybe Greg you could kick it off and then turn it over to Jorge.
GREG Hamilton (CEO Epigenomics):  Well, thanks. I'm Greg Hamilton. I'm CEO of Epigenomics. I've been with epis since 2016. and so my background is in molecular diagnostics and specifically in cancer screening. So I worked at various companies one of which was Third Wave Technologies where I actually met Jorge and we got a product cleared for cervical cancer for hpv. So with that i'll kick it over to Jorge.
JORGE GARCES (CSO Epigenomics):  Thanks Greg good morning good afternoon everyone Jorge garces I serve as president and chief scientific officer for Epigenomics have been in the oncology arena for over 20 years, have a phd in molecular biology and a business background as well. I’m very happy to be part of this endeavor . As you know we have a the ability to really make an impact in people's lives with a blood-based colorectal cancer screening test. So nice to meet nice to see everyone or hope you have a good day.
HOGAN MALALI (Encode):   So before before we leave your bios I have to sort of pull on a history thread here because it may be a little sort of provocative from an investor perspective, but I do think it's it's something that people do gravitate towards. Can you guys connect the dots between Third Wave Technologies Inc. and Exact Sciences. I do think that - again it's a little provocative from an investor perspective - but it's it is something that I think people gravitate towards.
GREG Hamilton (CEO Epigenomics):  Yeah so obviously there is a connection. Jorge and I were executives at Third Wave Technologies Inc. at the time Kevin Conroy was CEO. Kevin is is a friend,  someone we've known for a long time and we were very successful at Third Wave Technologies Inc. We developed an HPV product. When we got through the FDA trial, Holagic came in and bought the company out. As part of the transaction Jorge and I had to go to Hologic until that product got through its PMA clearance, which it did. And then obviously Kevin left and went in and went to Exact Sciences and he's really grown that company into the darling of the diagnostics industry. And you know, Kevin's always been a very bright guy. And as a friend and now we've kind of come full circle. And with my and Jorge's experience in screening, I was approached by epi to join the company as ceo with the US focus. So now we will be entering the market with an alternative product and one that we feel is a very disruptive technology. But at the end of the day, the good news is, Kevin's created a lot of value in this space and he's done a fantastic job. But - you know - the market's so big, he has less than two percent market share and so I think ultimately there are going to be many players that are successful in this space - but we do know it pretty well and at the end of the day I think both companies are going to make a difference.
HOGAN MALALI (Encode):    Terrific. Well thank you. I like to always try to make that connection given investors knowledge that Exact Sciences with the 14 billion dollar market cap sort of is the the darling of the colorectal cancer screening space.
Before we sort of jump into a more the sort of formal Q&A component just from the sort of the format of this. It's not gonna be a slide turn here. We're gonna do a very active Q&A. Investors can submit questions through the zoom app, if they have any questions. I have received emails from investors with questions already.  We'll try to get to as many as possible. I know the majority of people on the call have a pretty good working knowledge of Epigenomics already, but I know we'll have a few people who are new to the company. So maybe Greg you've already touched on a little bit of the highlights of the of Epigenomics, but can you give us sort of a quick sort of synopsis about, why people should be paying attention to Epigenomics here.
GREG Hamilton (CEO Epigenomics):   Sure, so the basic highlights of the company are,
1.) We're solving a huge problem and that is in the colorectal cancer screening market 35 percent of age eligible patients go unscreened. It's a big problem because the 35 percent of patients that go unscreened represent 70 percent of the deaths. So colon cancer is the second leading cause of cancer deaths in the United States despite the fact that ultimately this cancer is preventable. So clearly the market is telling us that we need alternative tools to solve this problem. Because the current solutions out there are not doing it - whether it's colonoscopy or stool based testing.  The fact the matter is, 35 percent of people are not compliant with those methods. So that's the issue, that we're trying to solve. So the opportunity for us is that there's an 85 million patients in screening age from 50 to 75. So it's a huge market. What we think we're bringing to the table is, the solution that's the first ever FDA approved blood test for CRC screening. So it is a disruptive new technology that we think has the potential to reach that 35 percent of the market that's unscreened. And so for us - you know - while that product is FDA approved, the reality is, that we are 30 days away from the biggest milestone in the company's history and that's Medicare reimbursement. Ultimately in the United States, FDA approval is a is a requirement, but really it's only the first step. The main step is reimbursement. Because as a screening test, you need the product to be widely reimbursed to be able to commercialize it appropriately. So, the great news for us is, that we are 30 days away from that decision. We are confident, that it's gonna be a positive decision. And that Epi ProColon is gonna be reimbursed by Medicare this year.
So, once that happens, then we can actively commercialize the product. And we think the upside of the product is significant.
HOGAN MALALI (Encode):    Terrific. Okay. I was going to jump right into that sort of CMS conversation but I did get a few email questions about more the basic science behind Epi ProColon. And I think a lot of us take for granted because it's FDA PMA approved - you know - that the science works. But I think for new investors it might be beneficial, Jorge, if you could maybe walk us through that. Just again, the majority of our audience are generalists. They're not technical folks. So I know that's maybe a bit of a daunting ask, to sort of describe a technology for more of a simple audience and from a non-science perspective. But can you kind of give us the sort of basics on the mechanism of Epi ProColon DNA methylation and septin9?
JORGE GARCES (CSO Epigenomics):  Sure Hogan. So, one really simple way to think about it is that genes primarily involved in cancer have two main functions and that's to speed up cell growth or cell division. And you might have heard of those genes called oncogenes. And then there's genes that are involved in slowing down cell division and those are tumor suppressor genes. And septin9 falls in the tumor suppressor bucket. It acts as a break to regulate the division of cells. If you get uncontrolled division, then that leads to cancer. And so methylation is a mechanism often used to shut down genes. And we found that methylation of the promoter region of septin9 actually shuts the gene down and prevents it from slowing down the cell division and therefore leads to cancer. As a marker for colorectal cancer - although septin9 has been identified in a number of cancers - it is highly associated with colorectal cancer. For example, when we look at biopsies of colorectal cancer tissues we find methylated septin9 in about 97 % of all those cancers. And so the idea was - without having to do a biopsy. We know that these tumors go through cycles of cell death. And then the cells that die spill out their DNA into the blood. So the idea was, would there be a mechanism to detect that DNA out of blood? And that's in essence what our Epi ProColon test is. It is the ability to detect tumor DNA out of blood without having to take a biopsy of the tissue - hence liquid biopsy is is the name of the technology. So hopefully that helps.
HOGAN MALALI (Encode):    Oh that's perfect. Thank you. Okay, so we've sort of done the investor piece intro and the science piece intro. So let's jump into sort of the more sort of thematic questions that I think a lot of people have. And I think if there's one question we get from investors more than any other:  Epi ProColon has 70 % sensitivity versus 90 % sensitivity when we look at Excat Sciences Cologuard. So how do you guys address that that sensitivity question? How does 70 % compete with 90 % is basically the question, that's probably the most common that we hear.
GREG Hamilton (CEO Epigenomics):   Okay, if you can jump to slide 11. Okay. So the reality is in how testing works. In essence, there's two buckets for testing. There's diagnostic, which is a majority of testing that goes on. So diagnostic is when the patient has symptoms and you need to find out what's wrong. And in that world clinical sensitivity and specificity are fairly analogous with the effectiveness of a test.
However the screening world is different. In the screening world you are testing patients that are asymptomatic. They're healthy patients. You're looking for someone who probably doesn't even know that they're sick. So what you have here is, that other factors that come into play. And those factors are time and adherence.  
So on a disease like colon cancer, that is very slow progressing - on average it takes 20 years to go from a polyp to cancer - what happens here is, that clinical performance is a factor but it's also impacted by time. So what you'll see here on slide 11 is in essence the problem of colon cancer and then how screening addresses this problem. If I had a thousand patients that were being screened for colon cancer, what you would find is about 65 would develop colon cancer. So the incidence rate of colon cancer is six to seven patients out of a thousand. So that's what the blue bar here represents. If you don't get screened out of a thousand patients six to seven patients will develop cancer.
Now when we interject screening, what you'll notice is, that the various screening methods all have different intervals or time frames by which they test. A colonoscopy for instance is done every 10 years. Colonoscopy is highly sensitive and highly specific, but it is only done every 10 years. Cologuard or FIT DNA is done every three years that test has a 92 percent sensitivity. Our test Epi ProColon has about 70 % sensitivity and so does the FIT test - anywhere from 70 to 74 %. In this analysis I think it's 74 %. So what you see here is, when we introduce screening, we reduce the incidence of the cancer. That's the graph on the top and more importantly we can reduce the mortality of the cancer. So what you'll notice is, that FIT DNA has a 92 sensitivity, but done every three years, it actually reduces the incidence less than Epi ProColon which is 70 percent, because Epi ProColon is done every year.
The way for people, who are not really experienced in oncology, to think about is cervical cancer. For instance the pap smear test - introduced in the 1950s - is anywhere to 50 to 60 percent accurate. So that's not great. However, because that cancer is also very slow progressing. And what's happened, when that test was introduced, women started going to their OBG (Untersuchung) every year. And when you test with a 50 to 60 sensitive assay every year, they were able to reduce the incidence and mortality of cervical cancer by over 90 percent after that test was introduced. So when we think about various tests, the ultimate goal is, how effective is it? Does it reduce the incidence and the mortality of the cancer? And what the data clearly shows is, that ultimately all of the methods work. So Epi ProColon works, Cologuard works, FIT works and colonoscopy works. And what you can see is, we all work relatively the same. We're all within the same 95 confidence interval of each other. So ultimately the story here, is what the guideline societies are now saying, which is the right test is the one that gets done. All right. That is why 70 % of the deaths come from the 30 to 35 % of the market that's unscreened. So, ultimately if we can get that population screened, the incidence and mortality of this disease will reduce greatly. So at the end of the day, when people talk about the sensitivity of 92 % versus 70 %, the ultimate question is, how effective is the test? How much does it reduce the likelihood, that I will either get the disease or that I will die from the disease? And ultimately what you see is, we are all relatively the same. We perform slightly better than Cologuard. FIT performs slightly better than us. But at the end of the day, the right answer is: Just get screened.
Now, when you take into account adherence - go to slide 12 - what you'll see is, people's willingness to do the test, has a big outcome. And that's actually quite honestly one of the big problems with the current available methods.  People really don't want to do an invasive technology like colonoscopy or they don't want to do a stool test. A blood test is much easier to use and patient friendly.
And when you incorporate adherence into the paradigm, which is a very real world reality, what you see is, actually a blood test does have the opportunity to reduce the incidence and the mortality of cancer more than all of the other methods.
So we do believe this is going to be a breakthrough technology, because a blood test is really going to change the paradigm. And how we think about screening.
 

HOGAN MALALI (Encode):    Jorge do you have anything to add maybe to that conversation?
JORGE GARCES (CSO Epigenomics):   I think Greg covered a lot of it. But one really good way to think about it is the shots on gold, that you have to detect these cancers. So they're very slow progressing cancers and if you have a test like colonoscopy you in essence only have three colonoscopies over a lifetime to pick up that cancer, right. If it's every 10 years. With Cologuard you have eight shots on goal over a 25 year period. And with the blood test or even a FIT test you have really 25 chances to catch that cancer, because you're doing it more frequently. Then the question becomes, well, am I willing to do something 25 times versus three times? And clearly the data shows, that people are not willing to do a colonoscopy. There's very low compliance with a stool test. People don't want to do something out of the everyday and play with their stool. And so blood tests fits very well with the standard of care for these patients. They go see their doctor every year. They get annual exams. It's just another blood tube from the same blood draw, that they have to provide in order to get screened. So it takes very little effort from the patient to participate in screening by incorporating a blood test. And so, really ease of use way, way outbenefits all the other factors, that that are often mentioned in in these type of screening programs. HOGAN MALALI (Encode):    And really the sensitivity for Epi ProColon is quite similar to FIT.
JORGE GARCES (CSO Epigenomics):    Absolutely.
HOGAN MALALI (Encode):    And FIT is really a gold standard test after colonoscopy. FIT is the next sort of the gold standard. And your label indicates that, correct?
JORGE GARCES (CSO Epigenomics):    Across all stages of cancer and across advanced adenomas which is a pre-cancer state we have the same sensitivity as FIT. We've done head-to-head comparisons to show that.
And really going back to the cervical cancer example that Greg laid out there. You know HPV screening came along many, many years later with a sensitivity of - funny enough - about 92 to 93 %. And what is recommended for cervical cancer today is: Either you do a pap smear test, which is only about 55 sensitive. And you do a pap every three years. Or you do an HPV test every five years. So again, you're spacing out the frequency of the tests based on the sensitivity. But they're both equally effective.
So, I think it's to just highlight specificity and sensitivity only tells a part of the story. The entire story is: How willing are people to do the test? How frequently can you do the test? And in the end can you reduce the mortality and the incidence of the cancer implementing any strategy?
HOGAN MALALI (Encode):    Okay, well thank you. That's great. So, I guess if there's the sort of topic du jour as you're a month away from a huge CMS reimbursement decision. You already have an FDA PMA approval. How is the CMS process different than what FDA looked at, when they approved Epi ProColon back in 2016?
GREG Hamilton (CEO Epigenomics):   Can go to the slide for “CMS Decision Criteria”. So when FDA looks at a test, then FDA is looking at the safety and efficacy [Wirksamkeit] of the test. So the big difference in FDA versus CMS is: CMS's criteria is defined as what's called reasonable and necessary. So reasonable is, that they need to check the boxes that it is safe and effective. So there are some tests that are presented to CMS that are not FDA cleared and they have to determine is it reasonable that it's safe and effective. Once it's FDA cleared, that's a box that the FDA checks and CMS just needs to make sure, that it's there.
The big thing that CMS looks at is what's called clinical utility. What are the long-term benefits and harms of the test in the patient population that the test is designed for? And so for Medicare specifically is it is it going to provide a benefit to Medicare patients. Is there a long-term benefit to doing the test? So ultimately in this space, that is proven by the data we just showed you, which is from a micro simulation model, that shows: Does the test reduce the incidence and the mortality of the cancer? That is the goal and that's the definition of clinical utility.
So the other main part of the decision from CMS is, is it necessary? And so there they look at wether there is a problem in Medicare patients, that they’re trying to solve. And this one's very easy. We know that there is over 9 million unscreened Medicare patients. So clearly a significant issue in Medicare. And a blood-based test has the opportunity to save over 225.000 lives and detect over four hundred thousand cancers just in the Medicare population. So ultimately that'll be their decision criteria.
I think, if you go to the next slide, ultimately we believe that you know the decision outcome will be positive because:
1.) It's an FDA PMA approved tes. So we check the box that it's safe and effective.
2.) We have peer-reviewed published data showing the long-term benefits and harm so documenting the clinical utility of the test.
3.) During the NCD review process, which has been ongoing in the first 30 days, was a public comment period and about 95 of the comments have been supportive of coverage of blood tests and specifically Epi ProColon
4.) And then in addition in April of this year the National Comprehensive Cancer Network or NCCN also included Epi ProColon in their CRC guidelines,
5.) And lastly, it is cost effective. That's technically not a criteria for CMS, but the reality is, that CMS has to look at cost because they have a certain amount of money. And this one is a no-brainer for CMS, because right now the big issue CMS has with colon cancer screening is, that they carry an undue burden of the treatment costs for colon cancer and that is because it's a slow progressing cancer the average onset for colon cancer is at age 67. So in essence the majority of the treatment of colon cancer falls on Medicare. And as we know 70 % of those people, that die from colon cancer, die because they didn't get screened. So what's happening is, people not getting screened in their 50s and early 60s are resulting in Medicare pain for expensive colon cancer treatments at 67 and beyond. So Medicare has published a paper saying that, if they can increase the screening rates by 10 percent, Medicare can save anywhere between 18 and 32 billion dollars by avoiding the cancers at a later stage in life at which time they cover. So for them it really is a very cost effective solution because a blood test is really a disruptive technology, that truly has the opportunity to increase the screening rates, which haven't changed in decades. And now we have the opportunity to go out there and get this 10 incremental screening benefit in the United States.
HOGAN MALALI (Encode):    You brought up the public commentary period the first 30 days of the NCD. When I went through the various comments I found it interesting that competitors or should I say maybe future competitors like Freenom and Garden who have liquid biopsies in development were commenting in favor of Epi ProColon's reimbursement or at least the reimbursement of liquid biopsies for colorectal cancer screening. Why would your competitors or future competitors, because they still got a clinical hurdle to overcome and a regulatory hurdle to overcome, be commenting in favor of reimbursement Epi ProColon?
GREG Hamilton (CEO Epigenomics):    The number one reason is the actual NCD is not specific to Epi ProColon. The NCD is for blood-based tests for CRC screening. So this is going to be the standard for all blood-based tests in the future for Medicare to provide coverage. So the reality is, as the first entrance into this base, we are in essence laying the groundwork for others behind us. That's just the reality of being the first. Now that said, so obviously it's in Gardens and Freenoms and all of their company's best interest that this NCD is issued and issued at such that the standards for coverage are achievable by them. So ultimately this is the direction CMS has been going. If you look back at the NCD they did for advance cancer therapeutic selection from next-gen sequencing - it's known as the foundation one next-gen sequencing NCD - they did something very similar. They made it generic not to the foundation one test, but basically any test, that used ngs to identify therapeutic selections for late stage cancer, would get coverage if it got FDA approval and was utilized in the therapeutic selection for that disease state. So that is the criteria by which then any new FDA approved product would get coverage.
Now for us, we believe, that this NCD will come out in 30 days. We know, that we are probably going to have at minimum a five year window, where we are the only blood test that is available in the market.
So if you can go forward a couple slides to slide 20. What you'll see is, that the reality is, that Garden, Freenom and even Exact Science is doing a blood trial right now. They have all just started their trials. With Covid19 most of those trials are on hold, because they're not doing screening colonoscopies at this time. Each of those trials is going to have to enroll somewhere between 10.000 and 14.000 patients, because that's the standard now to get a PMA approval in CRC screening. So those trials are more than likely going to take them three years to complete. Once they complete them, then they got to go through the FDA review process. It is a PMA. Average PMA time can be anywhere from 18 to 30 months. So we believe, if everything goes perfect for each of those players, they're still five years away. Now what is interesting is, each of those players is talking about sensitivity and specificity. And as we've just discussed that's only part of the story. Ultimately the story is how effective are they at reducing the incidence and the mortality of the cancer. So what you can see here on slide 20 is, even if we give each of these companies credit, that they're going to develop a test that has 90 sensitivity and 90 specificity out of blood, what does that mean for the reduction of the incidence and mortality of the cancer? Well again it depends on what the interval is. So here if you look at a 90/90 test with a three-year interval, it actually is less effective, than all the other available methods to date. So that test is actually inferior.
JORGE GARCES (CSO Epigenomics):    It's the last three bars.
GREG Hamilton (CEO Epigenomics):     Yeah, the last three bars of each graph. They show a 90/90 test of three years, a 90/90 test at 2 years and 90/90 at one year. So what you see is, that test would have to in essence achieve an interval of every two years or every one year to ultimately be a competitive test. However that is going to be a significant challenge for those players, because ultimately price plays a big factor. Most of those tests, that they're talking about developing, are next expensive next-gen sequencing tests. They're going to need to - in essence - get reimbursement similar to Cologuard, which is about five hundred dollars. All right, the challenge with that is, that Medicare has clearly priced the value of colon cancer screening across multiple different tests. So if you look at Cologuard over a 10-year period it's about 1.700 Dollars. Our test done every year over 10-year period is 1.900 Dollars. A colonoscopy done once every 10 years is about 2.000 Dollars. So the range is somewhere between 1.700 and 2.000 dollars. And it's a very tight range. If I have to do the 90/90 test every year to achieve the clinical benefit necessary, well now you're talking about five thousand dollars over a ten year period, because they need five hundred dollars for that test. It won't work! They will never get that pricing from CMS.
So ultimately, not only do we believe we clearly have a five-year runway, even if all of the other tests are successful and can get to market five years from now, they have an economic problem of how do they become competitive at an interval that makes sense to them. So ultimately, we believe the ability for Epi ProColon to be successful is not only the next five years, but in the long term as well. Because Epi ProColon is a PCR test, very simple to run and ultimately will be very cost competitive in the future as well.
HOGAN MALALI (Encode):    Gotcha. So not only do they have a challenge as far as needing to complete their clinical studies and have successful clinical studies and get through FDA, but they'll also have to either figure out some sort of cost effective way to market these things - either by driving their cogs down or something along those lines to be competitive.
GREG Hamilton (CEO Epigenomics):     Yeah and the reality is that their hope is, that they somehow can get the cogs down to a hundred dollars, right. But that's still significantly higher than a PCR test. And so ultimately even at a cogs of 100 Dollar - if they can achieve that - they still need to charge about 500 Dollars for that test, because in their model not only do you have to account for the cost of running the test, but they're independent clia labs. So they need sales force, they need a compliance department, they need to find out how they're going to get their hands on the blood. So in essence, are they going to go build 3.000 phlebotomy centers across the United States to collect blood? I mean you have to be able to get your hands on the sample. So their sample acquisition costs will probably be significant as well. So there are some significant economic barriers to that model.
JORGE GARCES (CSO Epigenomics):     Hogan, and going back to the NCD, I think it's in their interest to support our NCDs, because in essence they piggyback off the three-year effort, that we've been putting into getting this NCD issued. And it's to medicare's benefit as well, because it's really not very pragmatic for them to issue an NCD that is product specific every time right. Just think about how many products are out there, they would have to issue numerous NCDs. So the strategy is to generalize the NCDs based on intended use or application and then be able to set general criteria, that you know many different products can fit into.
HOGAN MALALI (Encode):    Okay, that makes sense.
Maybe I'm going to jump ahead a few questions, that I had to prepare. You brought up the commercialization strategies, that these new technologies may face. And one of the objections we do get when we talk to investors about Epigenomics is this sort of visceral response which is: How are they going to compete against Exact Sciences. You know Exact Sciences has got this incredible sales organization, which has been out there. And they're tenacious in tracking people down when they get their prescription for a Cologuard. But you guys are going about commercializing this very different than Exact Sciences went about commercializing their technology Cologuard. So can you walk us through how you envision commercializing Epi ProColon?
GREG Hamilton (CEO Epigenomics):     Yeah, if you can go to the reimbursement slide 18, where we have the rates for the various tests. So the way the market works and what you got to understand is what Exact Sciences did was not the norm in this industry. If you look at screening tests today - let's take HPV for cervical cancer, which is a huge screening market in the United States - the way the HPV screening market works is, IVD kit manufacturers sell a test to labs in the United States. So that is both large reference labs like Quest and Lab Corp but also hospital labs. And by doing that, what happens is, in essence the hospital lab or the hospital system share in the revenue stream. So the way it works here is, that the doing of a HPV test is reimbursed at 35 dollars. So what will happen is, if a health system has their own clio lab, which many, many of them do, they collect the sample, they send it to their own lab and their lab gets 35 dollars for running the HPV sample. So the big players in this space like Hologic, Roche, Siemens, Abbott they make these kits - whether it's HIV, HCV - and they sell them the hospital system. And they will - in essence - price them as such, that the labs of the hospital systems have the opportunity to make a profit on getting reimbursed at 35 dollars or for HIV 85 dollars. So we - in essence - are tapping into an already existing and well established process on how lab testing works in the United States.
Exact Sciences went the very opposite way, because they are their own clia lab. So what happens is, if a doctor writes a prescription for Cologuard, that sample never goes through the local hospital system. It only goes to Cologuard's lab. Cologuard runs it and Cologuard gets 510 dollars in reimbursement.
Our process will work very differently. So what will happen is, if you take for example in New York, if you're a Mount Sinai patient, you go see a Mount Sinai doctor. What would happen is, we would sell this Epi ProColon test to the Mount Sinai lab. You would then get an Epi ProColon test prescribed. After seeing your doctor in the Mount Sinai office, you'd go down to the mount sinai phlebotomy station, where they draw your blood and in essence Mount Sinai would receive 192 dollars for screening you for colon cancer. As an example, if we charged Mount Sinai 100 dollars to buy our kit to run that test, Mount Sinai would make 92 dollars of profit. So now the Mount Sinai health system is sharing in the revenue stream for screening you for colon cancer. So ultimately, we believe that - in essence - the health system will do what is in their benefit, which is screening patients, who ultimately have the appropriate reduction of the incidence and mortality of cancer. But it also is economically viable for them to now collect 192 dollars for collecting one incremental tube of blood. It will be a highly valuable molecular diagnostic test in the space.
So if you imagine a Quest and Lab Corp. for instance, each of them has over 2.000 phlebotomy centers across the United States. They process more blood than anybody. We're already tapping into that network, the people who are already handling the blood samples. And Lab Corp. is already ordering the test. Quest already uses the test as an LVT. We believe they'll switch over once the NCD comes out, because you need an FDA approved test for reimbursement. So ultimately, we believe that this distribution model is the appropriate one, because it has been tested and it has stood the test of time. And if you look at all of the other large molecular diagnostic tests in the United States, that is the method for delivery.
HOGAN MALALI (Encode):    Is it safe to say, that Exact Sciences has basically owned the branded colorectal cancer screening market for the past six years? I mean, there are FIT tests out there, but they're not truly marketed and branded. So I mean, really there's 30 plus million patients that are unscreened.  Exact Sciences sold a million Cologuard tests a year. That's a massive market, that has not been tapped into by any other branded product out there. Is that a safe assumption?
GREG Hamilton (CEO Epigenomics):     That is correct. So now to be fair, Exact Sciences has done everyone a huge favor, because they've increased awareness. And at the end of the day, that benefits us as much as anyone else. But yes, we will be the only other truly branded non-invasive product out there. FIT as a commodity product. FIT is very cheap. There's no branding on FIT or FOBT, that's really material in the market. So at the end of the day Cologuard has been very successful. They've done a lot of very brilliant things with their direct consumer campaign and we're very supportive of it. At the end of the day the market is so big, that there are going to be multiple players that are successful. We don't have to take share from Exact Sciences. The reality is Exact Sciences has - now that you include patients from 40 to 50 in the screening category - there's now over 100 million patients that are supposed to be screened. Exact Sciences did 1.7 million tests last year. They're less than two percent of the market. So the ultimate reality is, the market's so big, that they're going to be many players that are successful. And if Exact Sciences increases awareness and more people get screened, that's great. Ultimately as a company our belief is, if a patient wants to get a colonoscopy, great, go get a colonoscopy. They want to do a Cologuard test, great, go do a Cologuard test. The fact the matter is, that there's a huge problem in the market - 35 percent of the market don't get screened - and there is a significant opportunity for the blood test for Epi ProColon to drive screening compliance.
JORGE GARCES (CSO Epigenomics):    The other thing, I think it's important to add, is, that I think our path to profitability is a lot simpler than Exact Sciences, because Exact Sciences operates a clia lab.  There's two components to their test: There's a FIT component and then there's a DNA component that they have to do. And so their cost of goods is not as attractive.
So as Greg said, not only can we leverage the distribution channels of existing players like Lab Corp. and Quest to get the product out there. We only have to sell to about 200 high complexity labs in the United States rather than having to go and drive volume from the end users, which is over 200.000 primary care physicians. So I think the distribution effort is much lower. And then from a cogs perspective - you know this is a PCR test. So it's very easy to reach 80 plus margins on a PCR test in this market. I think that that's another important feature to think about.
 

HOGAN MALALI (Encode):    Right. I think, because it's a PCR test, I think we can assume, that as you get this test sort of going on volume, that you can drive those cogs down to pretty reasonable numbers. I know, that at Third Wave, we talked about getting cogs down to around maybe ten dollars? Was that was that right?
GREG Hamilton (CEO Epigenomics):     Yeah. So for big companies at scale a PCR kit at ten dollars is incredibly achievable.
HOGAN MALALI (Encode):    Okay. And if we look at maybe a 100 dollars, that you're selling the test to the Lab Corp.s and the Quests at a hundred dollars, then you've got 90 % gross margin potentially at scale. So that's obviously very attractive.
GREG Hamilton (CEO Epigenomics):     Yes. And so that's why we believe there's long-term viability in in the test, that there's a significant opportunity to be cost competitive. Ultimately at some point, way in the future, when that is necessary.
HOGAN MALALI (Encode):    Right. This is a bit of a loaded question. But I think it's important because of your history with Third Wave and Holagic and being part of M&A in the diagnostic space. Can you just from a sort of macro perspective talk about the how prevalent M&A is for sort of single asset? I know you've got a pipeline, but we're not gonna have time to talk about the pipeline unfortunately. So let's consider you a single asset company with CMS reimbursement in hand.  What's the prevalence of companies like this in your experience or with the prevalence of M&A in this space? I guess that's the sort of loaded question that I'm trying to get across.
GREG Hamilton (CEO Epigenomics):     Yeah. I mean the reality is, that smaller micro cap companies that have a key significant single product, a lot of times they are approached and ultimately taken over by larger organizations for many reasons - for example the ability to commercialize, the infrastructure already in place. Another reason in this space, which is unique to molecular diagnostics, are instrument platforms. As you talk about very high volumes - look at HPV, where some labs run 400 to 500 tests a day. When they do that, they run on automation and so a lot of the larger players in this space have FDA approved automation platforms and they're looking for content to add on to their platforms. So it is very common for single assay companies to ultimately be acquired.
That said. We're public. The reality is, we are a publicly traded company. We're for sale every single day on the market. We manage the business as what do we need to do to grow the company as optimally as possible. And that's how we will continue to manage it. To in essence put ourselfs in position to commercialize this product and to realize the significant opportunity in front of us.
JORGE GARCES (CSO Epigenomics):    Yeah. I mean our job is to maximize shareholder value. To maximize the value for our shareholders and so I think, that - for example - if you look at Exact Sciences, they've created a 15 billion dollar entity. But that's taken time. Since Kevin took over it has taken over 10 years to do that and over - I would say - 3 billion dollars of investment in terms of the capital he's raised.  So the equation we always look at is time and the level of investment and then the return. In the end, do we maximize value by taking advantage of a larger entity's infrastructure, speed to market et cetera. And for a lot of companies that's been the answer. It doesn't necessarily mean that's the answer for Epi, but it certainly has been the answer for a lot of companies to leverage the investment and the infrastructure of a larger company to be able to get the product out there quickly.
HOGAN MALALI (Encode):    Sure. That's great. I appreciate that guys. That's a bit of a kind of a loaded question anyways. Just a quick question as far as August 28th is concerned. This will be a preliminary CMS decision. The final CMS decision is November 28th. What can we expect?
GREG Hamilton (CEO Epigenomics):   I'll answer that on the in regards to the process. So the way the NCD process works is: A proposed decision is issued by August 28th. Following that will be a 30-day public comment period, much like the public comment period we went through the first 30 days of the NCD. Then when that public comment period closes, by statute CMS has to issue a final decision by November 28th. So when CMS issues the final decision, assuming it's positive, which we believe it will be, in essence the test goes live for Medicare reimbursement that day. So any patient with the date of service on the date that the final NCD is issued would be covered.
HOGAN MALALI (Encode):    I've got some investor questions, that I want to get to quickly. A couple of questions on around intellectual property. Do you guys want to comment on intellectual property around Epi ProColon?
JORGE GARCES (CSO Epigenomics):    So Greg, I don't know, if you want to comment. But you know I think that we have a very strong IP portfolio as a company. And that’s one of the great assets to Epigenomics with over 300 patents either granted or under review. Our core patents extend out to about 2026. But you know we have extensions that we've been filing obviously to take it beyond that. Obviously the IP is important in terms of barriers to entry, but as we've discussed in the past, these clinical trials, FDA approval and reimbursement are an additional three very large hurdles for other companies to enter the market. So we certainly keep a very close eye on IP and make sure that we have not only the freedom to operate but also can prevent others from using our technology in this application. HOGAN MALALI (Encode):    Perfect. Greg that that summed it up nicely. Anything different from you or anything to add
GREG Hamilton (CEO Epigenomics):   No.
HOGAN MALALI (Encode):    Okay, perfect. I guess it would be important for us to also talk about - this is a binary decision come August 28th - I think the market cap is so reasonable, that the upside obviously should outweigh or should be attractive to those of us, who like these sort of catalyst investments. But what is the downside here? What happens if on august 28th we don't get the favorable decision? What's the next step for you guys? What process can you go through to sort of revisit CMS approval?
GREG Hamilton (CEO Epigenomics):   Yeah, there is an appeal process for CMS. It's called a reconsideration. So we would obviously apply for a reconsideration process. The reality is, that a negative decision on the NCD is not something we'd be looking for. There is a path forward with a negative NCD. However it will take us time to go through an appeal process with CMS. We actually think the likelihood of that is very, very small, because like you said Hogan at the end of the day, we have checked all of the boxes for CMS. And the reality is CMS does not accept and then do an NCD unless they feel that there's a strong likelihood, that they're going to cover. So, if you look at the history of NCDs, most of them are for coverage and the reason is that because there's a hurdle for them to even accept and then process the NCD. They have to believe there's adequate evidence that it's going to provide a benefit to Medicare patients. That's their standard. So by default just getting an NCD accepted and then processed means that they really believe that there's evidence there, that this is going to go forward.
So when you add on that FDA approval, clinical utility data, guidelines, there really is not a box that we haven't checked that ultimately would provide coverage. And if you look at all of the other screening tests like HIV, HPV and you look at the NCDs for those tests, basically it's not specific to any one test, it's a generic NCD, that says Medicare will cover any HPV test, that's FDA approved. That's the standard
HOGAN MALALI (Encode):    Okay. A couple of questions. We only got a few minutes left here. I know some people so from a cash burn perspective, balance sheet, where do things currently stand? What are your plans for future capital needs? Can you address that?
GREG Hamilton (CEO Epigenomics):  Yeah, so we had our shareholder meeting in June and we have the approval to raise capital in two ways. First of all we have enough cash to get through Q1 2021. So we have enough cash to get through our major milestone decisions.
That said we don't have the cash necessary to obviously go commercialize the product. We have two mechanisms to raise capital. One is a pipe, where we can issue out up to 10 % of our shares which would be about 4.7 million shares. And we can do that quickly and add cash to the balance sheet in short order. The other is a rights offering. We have an additional 40 percent of our outstanding shares we could issue in a rights offering. That process is longer. It typically takes us about three months from start to finish to execute a rights offering. That includes a prospectus, we go to market, we announce it. We have said on our previous earnings call, that obviously we will look to raise capital this fall. We need to, because we only have enough cash to get through Q1 2021. So as we enter into the fall, we have two mechanisms - one we can work on quickly and add some cushion to the balance sheet right away and then the other one is a longer term process, which would push us out into later in the year to raise that raise capital.
HOGAN MALALI (Encode):    Okay. That dovetails into the last sort of not even a question but just sort of a comment. I mean, obviously you're not on a national US exchange. I know people would love to see you traded on Nasdaq. I know you've got restrictions on, because of your German roots on how that can be sort of accomplished. Can you just talk to people about how they may buy this? How the stock trades in Germany on Frankfurt but also other exchanges? Can you just talk about those two exchanges because I think there's more liquidity there.
GREG Hamilton (CEO Epigenomics):   Yeah, so the main the main exchange that we trade on is xterra (Xetra), which is the electronic platform in Frankfurt. So ecxde. We are seeing increased liquidity on that exchange, which is good. We've seen a significant rise in the stock price in the last four months obviously in anticipation of the NCD decision of coming. We think there's obviously much further growth availability in the stock. I mean we believe the stock is significantly undervalued. I don't think there's any rational person, that would argue, that if we could wave the magic wand and take a company with the first ever FDA approved liquid biopsy product 30 days away from a reimbursement decision and put them on the Nasdaq, the company wouldn't be worth at least three times what it is today. But the reality is, that you know we trade on the Frankfurt exchange. But the ecdx is fairly liquid and we think there's significant opportunity and upside for everyone involved, because ultimately when you look what Exact Sciences has done, they've done great things in the market, but they eclipsed 15 billion this week, I think. So there's obviously a lot of room for market share growth in this space. I mean, you're talking about a company that's got two percent market share and is a 15 billion dollar market cap. So clearly for us, we believe, with a blood test there's significant upside.
HOGAN MALALI (Encode):    Well terrific I think with that we've touched the bottom of the hour that's exactly one hour. I want to thank Greg and Jorge for giving us their time. We are obviously very enthused and excited about the prospects for Epigenomics will be very active and following you as we head into this massive decision on August 28th, which we believe will be favorable much like yourselves with that I think I know there were some I know there were some questions we didn't get to this this has been recorded we will publish it on our website so this will be yeah you'll be able to revisit this thank you everyone for participating thank you Greg thank you Jorge thank you ryan in the background for being rit guy and yeah we'll leave it at that so thanks thank you everyone appreciate everyone taking the time bye bye thanks

ENDE  

Inhaltlich alles ok. Aber wie HF schon sagte , der Ton könnte ein wenig anders sein. Und wenn man sich bei Epi etwas mehr auskennt als andere ist das nicht gleich ein Alphatierchen. Würde weiter hier schreiben.  

Auch wieder mal da!!! Bei so viel Arbeit hoffe ich dass du noch investiert bist. Diesmal wird es das erste Mal klappen, die Voraussetzungen sind einfach andere als bei der FDA oder der ACS. Die CMS prüft etwas näher bevor sie einen 9-monatigen Prozess anfangen. Und wenn von 67 Kommentaren nur ein einziger wirklich negativ ist ( ein Übergangener aus 2014!), dann können sie praktisch nicht anders. Immerhin waren die ganzen Koryphäen in diesem Sektor darunter. Und ein zweites Mal wird es eher nicht geben trotz Einsprachemöglichkeit. Gruss nach Berlin.  

Danke für die Rückmeldung, Mogli. Hinsichtlich des Tons bin ich anderer Meinung. Stichwort Sender und Empfänger. Jeder scheint es so zu lesen, wie es ihm in den Kram passt, inklusive meiner Person, siehe meine Reaktion auf Guru. Meine Intention war konstruktiv. Wer mich als Mensch und beruflich als Führungskraft persönlich kennt, käme nicht auf solche Auslegungen meiner Worte, wie ich sie hier lese. Aus kommunikationsanalytischer Sicht spannend.

Daher: Ich habe schlicht keine Lust, mich ab von der Sache an für mich befremdlichen Befindlichkeiten abzuarbeiten. Nichts für ungut und danke im Voraus für Eurer zukünftiges Engagement hier.

Danke für das Transkript! Steckt mehr drin, als ich erwartet habe, spannend und ermutigend.  

Für dich als Führungskraft wäre doch gerade das spannend. Aber schon der Hinweis darauf ist aufschlussreich. Schöner Sonntag  

philojoehus.
gerade für mich ist dies eine große hilfe.


aus teil 3, die letzte antwort von gh,  daraus
" ich glaube nicht, dass es eine vernünftige person gibt, die argumentieren würde,
wenn wir den zauberstab schwingen und ein unternehmen mit dem ersten von der FDA
zugelassenen biopsieprodukt 30 tage vor einer erstattungsentscheidung nehmen
und sie auf die nasdaq setzen könnten, wäre das unternehmen nicht mindestens
dreimal so viel wert wie heute. aber die realität ist, wie sie wissen, dass wir an der
frankfurter börse sind. "

aus dem übersetzer. etwas kauderwelsch.
aber jeder versteht:  an der nasdaq wären wir aktuell ca. 5,50 euro wert.  
glaube zum zeitpunkt des interview stand der kurs bei etwa 1,80 euro.  

Der GH kann das ja nicht direkt sagen. Aber für mich ist klar. Kommt nicht sofort nach dem 28.11. ein Übernahmeangebot dann gehen sie an die Nasdaq. Kaufen kann man epi in den USA ja schon über OTC. Kap I mit den 10% kommt noch gleich im Dezember in Frankfurt und die 40% dann an im Zusammenhang mit der Kotierung an der NASDAQ.  

Bitte schreibe hier weiter,  HFreeser  sagt nur seine Meinung, aber hier lesen noch die anderen mit!
 

bisher war ein übernahmeangebot nach dem entscheid für mich so
sicher wie das amen in der kirche.

ich komme nunmehr ins grübeln,
insbesondere durch den  deutlichen hinweis von gh in derm interview auf
die sehr wichtige rolle der labore ( siehe einen beitrag von hal in den letzten tagen )
bei einem möglichen markteintritt.

ein listing an der nasdaq könnte tatsächlich eine ernsthafte alternative sein/werden.

( welch ein luxusproblem bei dieser pommes bude ).  

Hier ist  ein Forum  aber kein Wettbewerb!  

Korrekt. Wozu noch jemand übernehmen lassen, wenn bei einem Nasdaq Listing genug eingespült wird, um selbst durch die von GH aufgezeigten Vertriebskanäle eigenständig am Markt zu agieren?

Was den Zeitvorsprung von 5 Jahren betrifft folgende Frage. Arbeitet Epi noch an der Optimierung von ProColon, weil eine höhere Spezifität und Sensitivität würde doch theoretisch positiv auf das Intervall und somit die 10 Jahreskosten wirken? Damit könnten sie den zukünftigen Konkurrenten nochmal einheizen, wenn das Intervall auf alle 2 Jahre bei gleichen Kosten oder geringer laufen würde auf 10 Jahre betrachtet.

Mussten bisher alle CMS Kandidaten auch eine Mikrosimulation anfertigen lassen?  

Nun ja, es wäre ja auch fatal wenn sich GH nur auf eine Übernahme einstellen würde. Das würde einen Übernahmepreis (wenn nur ein Interessent vorhanden) eher senken. Er muss zweigleisig fahren. Und das wird er auch tun.  

Was ist ungefähr gesichert ( wir kennen die Verträge ja nicht genau), was noch relativ offen? Geändert wurde der Vertrag mit Polymedco ( HV von 2019). Polymedco hat weniger Aufgaben und die Umsätze laufen voll über Epi. Die Labore kaufen Epi für ca 100$ den Test ab und erhalten von den Kassen die 192$. Epi bezahlt die Herstellungskosten und die Dienstleistung für Polymedco( vor allem Vertrieb). Die Herstellungskosten sind bei kleineren Mengen ca 20$, können bei großen Mengen( über 1 Mio pro Jahr) bis auf 10$ sinken. Offen ist was Polymedco bekommt. Im alten Vertrag waren das um die 30-35$ pro Test. Im neuen Vertrag werden es zwischen 20 und 30$ sein. Das heißt Epi verdient pro Test zwischen 50 und 60$ je nach Höhe des Absatzes pro Jahr.

 

Deine Zusammenfassung gibt dadurch die Gelegenheit, gewisse Passagen noch mal nachzulesen, obwohl die Faktenlage beim Kurs von < 1,30 auch schon vorlag und, wie Du auch schon geschrieben hast, sich eigenlich nichts verändert hat. Daher teile ich Deine Einschätzung über die zur Zeit herrschende Euphorie. GH's Einschätzung über die niedrige Marktbewertung, obwohl er selbst persönlich nicht groß eingestiegen ist, und über die aus seiner Sicht positiv ausgehende CMS-Entscheidung sagt aus meiner Sicht nichts aus, da er bereits so oft daneben gelegen hat. Genauso wie damals ACS wird CMS auch diesmal nicht Epi vorab bereits ein Ergebnis mitteilen.
Die Einschätzung, dass nicht umbedingt eine Übernahme kommen muss und wird, gibt es hier im Forum auch schon seit längerem, wurde aber immer von einer Gruppe ignoriert. Entscheidend sind hier die Großaktionäre.    

Recht geben: Hier ist schon wieder eine Euphorie auf dem Board. Zu viel Euphorie und Sicherheit sind aber nie gut für Aktienkurse. Weil, wenn am Ende das eintritt wovon viele sowieso schon ausgehen, bewegt sich am Kurs nicht viel, bzw. muss wieder irgendetwas Unvorhergesehenes oder Unerwartetes kommen.

Um mal die Euphorie ein bisschen einzubremsen:

- wir haben einen  71/80 Test, der ist ok aber von der clinical performance auch nicht atemberaubend
- wir haben dadurch eine gewisse Unterdiagnose aber auch Überdiagnose in Form von 20% falsch Positiven
- die falschen Positiven haben auch eine Belastung zu tragen, nämlich dass sie potentiell CRC haben könnten, die in die Koloskopie müssen (alle Hypochonder dürfen sich angesprochen fühlen)
- von 1 Mio Getesteten müssen also 200.000 in die Koloskopie, das kostet 400 Mio. CMS zusätzlich (die Kosteneinsparung für CMS gibt Epigenomics mit 25,5 Mrd. über einen Zeitraum von 50 Jahren an, wenn durch ProColon die Testquote um NUR 10% erhöht wird - Seite 15 in der Präsi vom 16.07.20)
- nach MS geht ja Epi schon davon aus, dass der Test nur die entsprechenden Ergebnisse bringt, wenn jährlich erstattet wird (woher wissen wir ob CMS 192,- jedes Jahr bereit ist zu zahlen?)
- wenn ein ehemals Screening Verweigerer ProColon nimmt und positiv getestet wird muss er zu Koloskopie (darf er danach zurück in das ProColon System?)
- das Kernpatent Sept9 läuft 2026 aus - kann aber verlängert werden
- Ohne Übernahme bekommt Epi mit Kap.I und II (10 und 40% von der Aktienanzahl) bei aktuellem Kurs 80 Mio frisches Kapital. Das reicht für eine Markteinführung vermutlich nicht aus.
- Wenn  Epi das auf eigener Kraft nicht hinbekommt kann der Wettbewerb auch einfach zuschauen, wie Epi ausblutet...

Unsicherheit ist wichtig, Freunde ;-)

Und jetzt sollten wir mal wieder etwas kontroverser diskutieren.

An opportunity is a moving target...  

was ist so bemerkenswert oder gar zu kritisieren
wenn gh in einer   frage/antwort runde   über eine stunde
27 mal  " letzten endes "  und 17 mal ( oder mehr )  "  im wesentlichen "   sagt.



 

der Artikel ist zwar schon fast vollständig hier im Forum beschrieben worden, aber nun ist die offzielle EamS-Seite im finanzen.net veröffentlicht:
https://www.finanzen.net/nachricht/aktien/...asie-made-in-usa-9106437

Für Epigenomics könnte der 27. August entscheidend werden. An dem Tag will die US-Gesundheitsbehörde CMS festlegen, ob die Kosten für den Darmkrebstest der Biotechfirma von der öffentlichen Krankenversicherung erstattet wird.
€uro am Sonntag
von Peer Leugermann, Euro am Sonntag
Sollte das Votum positiv ausfallen, könnten die Berliner vor einem Umsatzsprung stehen. Der Epi Procolon genannte Test ist die einzige von den USA zugelassene Darmkrebsvorsorge, die mittels einer Blutuntersuchung funktioniert. Das Konkurrenzverfahren der Firma Exact Sciences nutzt eine Stuhlprobe. Auch deshalb nehmen erst 68 Prozent der Amerikaner an der Vorsorge teil. Die USA wollen die Präventionsquote auf 80 Prozent erhöhen. Epi Procolon zeigt laut Studien die höchste Annahmerate aller Testarten. Die CMS prüft daher, den Verweigerern der bisherigen Untersuchung einen Epi-Procolon-Test für 192 Dollar zu bezahlen.
Ein Rechenbeispiel: 2019 erzielte Exact Sciences mit 1,7 Millionen Tests 810 Millionen Dollar Umsatz, das Unternehmen bringt es auf einen Börsenwert von rund 15 Milliarden Dollar. Würde Epi Procolon von Epigenomics zu 100 Dollar an die Labore verkauft und eine Million Menschen getestet, wären das 100 Millionen Dollar Umsatz. Der Börsenwert von Epigenomics liegt bei umgerechnet 94 Millionen Dollar - vergleichsweise nichts. Auch Epigenomics dürfte jedoch viel Kapital für Vertrieb und Marketing benötigen. Chef Greg Hamilton ist in der Pharmaszene gut vernetzt, er war ein Kollege von Exact-Sciences-Chef Kevin Conroy. Einer Erstattung für Epi Procolon könnte womöglich eine Übernahme von Epigenomics folgen. Nur sehr risikobereite Anleger setzen - begrenzt - auf ein Einmalereignis.
 

dass "die Forschung findet mehrheitlich in den USA statt"?
Lt. GB nimmt "die Epigenomics AG als Muttergesellschaft die zentralen Konzernfunktionen (wie Rech-nungs-, Personal-, Lizenz- und Patentwesen) wahr. Die Forschungs- und Entwicklungstätigkeit des Konzerns wird ebenfalls von Berlin aus betrieben."  

aufgrund der ähnlichen Sens.-Werte müßte FIT ähnlich viele falsch Positive in die Koloskopie schicken.
Und diese Personen sind m. E. dann erst mal für die nächsten 10 Jahre raus aus dem Screening-Intervall der anderen Screening-Methoden (FIT, FIT-DNA, proColon etc.) raus.
Wenn die falsch Positiven die Anzahl der Darmspiegelungen erhöht, wird eigentlich doch auch der Wunsch der Inanspruchnahme der Koloskopie als Goldstandard erfüllt. Wie schon in den CMS-Kommentaren beschrieben, wird m. Meinung nach deshalb proColon erstmal auch nur für die Ungescreenten erstattet werden.  

Auch mal an die Intervallkarzinome denken, das sind beispielsweise die bösartigen Darmtumore, die trotz durchgeführter Darmspiegelung plötzlich („im Intervall“) auftreten

https://www.lebensblicke.de/...zinome-der-albtraum-des-endoskopikers/

Aus diesem Grunde ist es durchaus denkbar, dass EpiproColon den Ungescreenten angeboten wird, aber vllt irgendwann auch „im Intervall“ der Darmspiegelungen  

https://www.epigenomics.com/wp-content/uploads/...v-2019_DE_final.pdf

Seite 3 unten: Das wichtigste Ergebnis dieser Studie ist, dass EpiproColon bei jährlicher Durchführung als effektive nicht-invasiveCRC-Screening-Strategie die gleichen langfristigen Vorteile anderer derzeit empfohlener CRCScreening-Methoden bietet...(...)....

———-

 

Zur Zeit laufen drei Studien. Eine findet in Nancy statt zu HCC, das ist eine Eigeninitiative von dem Arzt dort, epi hat nicht den Auftrag dazu gegeben. Die zwei anderen Studien laufen in den USA, die HCC Studie und die Post Approval Studie zu Septin9. Der Forschungschef Garces ist in den USA, die beiden Hauptforscher DeVos und Potter sind in den USA. In Berlin schieben die vielleicht noch ein paar Reagenzgläser rum, mehr nicht.