Epigenomics Enrolls First Participant in its FIT Comparative Study with Epi proColon®

OneMedRadio interviewed Thomas Taapken, CFO of Epigenomics, a Berlin based molecular diagnostics company for the early detection of cancer. The company’s products enable doctors to diagnose cancer earlier and more accurately, leading to improved outcomes for patients.

Epigenomics’ lead product, Epi proColon®, is a blood-based test for the early detection of colorectal cancer, which is currently marketed in Europe and is in development for the U.S.A. The Company’s technology and products have been validated through multiple partnerships with leading global diagnostic companies including Abbott, QIAGEN, Sysmex, and Quest Diagnostics. Epigenomics is an international company with operations in Europe and the U.S.A. The company recently announced the start of the head-to-head comparative study of Epi proColon® with fecal immunochemical testing (FIT) for colorectal cancer detection. The first study subject has been enrolled.

Click below to hear the full audio interview and see transcript to follow.

Brett Johnson:           Welcome. This is Brett Johnson with OneMedRadio in New York City. Today, I am with Thomas Taapken, who is the CFO of Epigenomics. Epigenomics is a Berlin-based firm, became public in 2004 developing personalized medicine in the diagnostics area, tools especially for lung and colon cancer most notably. They’re traded on the Frankfurt Stock Exchange under the symbol ECX. Thanks for joining us today, Thomas.

Thomas Taapken:      It is my pleasure, good afternoon and good morning.

BJ:  So tell us a little bit about the background of Epigenomics and in particular your colon cancer test.

TT:   Yeah, it would be my pleasure. So Epigenomics is a company that was formed around the concept of epigenetic variations of DNA as a method of identifying cancer in different sample types. We started off our research more in the tissue area and moved slowly from there and developed blood-based test for the detection of different cancers, one of the most advanced being now our blood-based test for the detection of colorectal cancer.

BJ:   Now colorectal cancer obviously has been a problem and one that’s recognized as easily addressed if it’s diagnosed early enough. Obviously, the colonoscopy is the principal way that this diagnosis is occurring. I assume that the appeal of the blood-based test is because it’s less invasive? Is that what you’re seeing as a driver here?

TT:   Absolutely, Brett. That’s correct. The invasiveness of colonoscopy and the alternative being stool-based test have the big drawback that a lot of people choose not be screened for colorectal cancer, and that is really one of the biggest drivers for the deadliness of the disease and for the number of fatalities that we see each year and also for the huge amount of cost to the healthcare system that is incurred by colorectal cancer. So by screening more people, it will be possible to increase the compliance and therefore also to detect colorectal cancer earlier and with that of course bring more people into treatment early enough when the disease is still curable.

BJ:  Can you talk about the comparative effectiveness of the test versus the existing diagnostic tools?

TT:   Absolutely. I mean obviously still for the detection of colorectal cancer, colonoscopy remains the gold standard. It is certainly an invasive procedure, but it’s the best procedure that you can have out there and it is recommended for every person over the age of 50 in the US for example. Nevertheless, next to colonoscopy, there is also other testing modalities like stool-based test and also with our test now there is a blood-based test out there that are performance wise still good enough to catch a fair amount of colorectal cancer cases. With the performances that we have shown in more than 14 clinical studies that we have performed so far, we are of the opinion that it will be possible to detect a significant amount of colorectal cancer cases early enough. To highlight the exact specificity and sensitivity of our test, we have seen in studies that we have run in Europe for registration processes here, sensitivities in the 90% range with the specificities in the mid 80 percentage points. We just completed a very big prospective study in the US where we saw a sensitivity for cancer of about 68% at a specificity of slightly above 80%.

BJ:   How does that compare with existing tests in terms of specificity and sensitivity?

TT:  Well that’s a very important point. It is so that there is fairly little data out there that has been collected on these kind of prospective studies as there are required for example for registration purposes under PMA with the FDA. So we are basically now at the forefront of generating some of these data and one of the things that we are doing ahead of our submission for PMA in the US is to run a study in which we will compare our tests head to head to the most sophisticated fecal-based test out there, which is called the FIT test. The goal here is to show that our test is non-inferior to the fecal testing that is available today.

BJ:   Interesting. So what’s the status of this test and when it would reach the market?

TT:  Well in the European markets, we have initiated selling the product about a year and a half, two years ago and we have just introduced the more advanced version of the test a couple of weeks ago here into the European market. For the US market though, it is necessary to gain FDA approval and what we have initiated now is a process of submitting a premarket authorization approval to the FDA. The way of doing it has been for us to divide the application in different modules that are going to go subsequently into the agency for their review. We have by now submitted two of the four modules necessary to the FDA, one in December of last year, one just a few days ago. We plan to deliver the modules three and four still in this year to the FDA for their review expecting 2013 approval of the product in the US.

BJ:    Okay. In terms of the marketing and distribution of this test, how will that occur?

TT:   Well that is a very interesting question because we realized that as a small company, we will not be able to address the entire market. So what we have decided to do is to grant licenses to big players in the diagnostic space so that we are — basically a number of companies out there offering tailor-made and customized solutions to the customers out there, which will be the testing laboratories in the US. So apart from our own version of the test, we expect that our partner Abbott will develop their own version or is in the process of developing their own version of the test. We have also given a license to Qiagen or better said an option to a license to Qiagen who is now working on adapting the test on their own instrumentation platform in order to be able to develop it for the US market as well.

BJ:  Has there been any sort of studies or any sort of basic view of the size of the market for this test and sort of the economic impact the test could have in terms of revenues for your firm?

TT:  Well of course. I meant the market that is associated with colorectal cancer screening certainly is an immensely big market. As I said earlier, there is a healthcare cost of $14B to the US healthcare system that is incurred every year through colorectal cancer so everything that can avoid any of that cost will be a huge contribution to the health economic equation. We have demonstrated in health economic studies that our test has a health economic benefit if it manages to do what we expect it to do, which is to increase the number of people that adhere to colorectal cancer screening early on. So we expect conservatively that the market for such products should be in the hundreds of millions of US dollars a year if not in the low billions a year and that is basically something that has been confirmed with market research in different areas.

BJ: I see. So once this test would be approved assuming you can get good distribution, there could be a very large topline revenue that would accrue to your company for the success of this test?

TT:   Well in fact, we expect of course to be able to generate a significant amount of topline revenue from the sale of our own product into the market. But nevertheless as I mentioned, we also have our partners so they will also contribute to generate sales in this market, which will then translate into royalty income for us as a firm. In the meantime, before there is an FDA approved product out there, we have started to grant licenses to some testing laboratories in the United States, which under the clear regulation in the US have started to offer the test already today under so-called LDT licenses.

BJ:  Interesting. Are there other competitors now who are developing some personalized sort of medicine or blood test or other alternative test in the colonoscopy field, the colon field?

TT:  Well we are aware of a couple of companies out there that are trying to develop tests for early detection of colorectal cancer and obviously, there are different concepts out there. There are blood-based concepts which we feel as far as we can judge so far have all their certain limitations so we feel quite optimistic about being able to offer the best blood-based test that is out there. There is a lot of companies out there that are improving on the concept of doing fecal testing and we expect of course there to see also an improvement in performance as we have seen over the last 20 years in which fecal testing has been done.

BJ:   Terrific. Can you tell us a little bit about — shifting gears here to your lung cancer test about the status of that and how does that different than I guess the methodology on the colon cancer test?

TT:    Yeah, indeed. It’s a very interesting product. It targets a totally different market because this is not a screening or early detection test, but nevertheless, it is a test that is based on the very same technology that our colon cancer test is based on, which is detection of DNA methylation in specific genes.

So our Epi proColon test, that’s the name of the test as we are offering here in Europe, is a very helpful aid in the diagnosis of lung cancer. As you might know, lung cancer is a disease at times is very difficult to diagnose and we see many situations where the diagnosis is inconclusive. The typical consequence of an inconclusive diagnosis is to wait a bit longer and to do additional analysis by chest x-ray analysis, which of course adds to the problem. Because if you wait longer and if you have to tell patients to come back in a couple of months or a couple of weeks, you will have a prognosis of the disease which will then of course deteriorate the outcome of the testing. So with this test, what we can do is we can provide to the oncologist and the pathologist basically with the tool to do a much better diagnosis early on in lung cancer also with the same goal to be able to treat the disease as early as possible.

BJ:  What is the status of that product in terms of marketability? Is it on the market and its prospect for its approval or use in the United States?

TT:   Well actually the product is again here in Europe now on the market. We have concluded a series of very interesting studies with top university hospitals in which it has been confirmed that the utility for the pathologist is actually quite high and we have now first customers starting to buy the test here in the European markets. For the time being, we’re not developing the test for the US. What we are trying to do though is we are looking for partners that would be willing, laboratory partners that would be willing to offer this as an LDT based test in the North American market.

BJ:  Well it sounds like it’s some very exciting developments. What do you see as the big milestones for 2012?

TT:   Well very clearly to complete the outstanding task that we have to do to complete our submission to the FDA. We are still in the process of running the direct comparison study of our colorectal cancer blood-based screening test head to head against the stool-based test, and we expect to be able to have all these results and all the study, the outcome from these studies completed before the end of the year to be able to submit it to the FDA.

BJ:   Terrific. Well we look forward to following your continued progress and we’ll certainly get back at you when you get some results back from the FDA. Thanks for joining us today.

TT:  It’s been my pleasure. Thank you very much.

BJ:   So that was Thomas Taapken, the CFO of Epigenomics, a Berlin-based company in the personalized medicine developing some interesting tests in colon cancer and lung cancer. The company is traded in the Frankfurt Stock Exchange under ECX. Thanks for joining us. It’s Brett Johnson in New York City with OneMed Radio. Good day.

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