Metabiomics is developing a noninvasive screening test for colon polyps in colorectal cancer based on human microbiome markers.
The company’s diagnostic test is the result of more than 10 years of research through which the company was able to discover and apply advances in next generation genome-sequencing technology to the microbiome in order to categorize microbiome communities. The data they amassed through their research has left them with a clear picture of how colon polyps in colorectal cancer influence the microbiome.
Specifically, they believe they can safely detect whether or not a patient has colorectal cancer based on the genetic code at a set of specific biomarkers in the microbiome that they have found to be associated with colorectal cancer. The company thus believes they have identified the genetic signature of colorectal cancer in the microbiome.
The early results of trials of their CLIA-certified test show that their assertion may, in fact, be true.
In an interview with OneMedRadio, Gregory Kuehn, Vice President of Business Development at Metabiomics, explained that the preliminary data showed “sensitivity in excess of 97%” and specificity “as high as 93%.” Mr. Kuehn thinks Metabiomics’ noninvasive test, which only requires a stool sample from the patient and returns results within 2 business days, represents a significant improvement over colonoscopies.
As he explains, 47% of patients avoid colonoscopies because of their invasiveness and inconvenience, and as it’s easy for doctors to miss small polyps during the examination. In short, it will both “cut healthcare costs and save lives,” and so could be well-positioned to make a dent into the $7.5 billion yearly market for colorectal cancer screening.
Metabiomics will present at the upcoming OneMedForumNY 2013 on June 27th.
Click to listen to the full OneMedRadio interview and view the interview transcript below.
Matt Margolis: OneMedRadio welcomes Gregory Kuehn, Vice President of Business Development of Metabiomics. Metabiomics is developing noninvasive screening tests for colon polyps in colorectal cancer based on human microbiome biomarkers. Thank you for joining us, Greg.
Gregory Kuehn: Thanks for having me, Matt.
MM: So I want to start with your platform technology. Give us an overview here.
GK: Metabiomics is developing a noninvasive screening test for colon polyps in colorectal cancer based on human microbiome biomarkers. Now we started looking at the microbiome more than 10 years ago from a microbial ecology perspective. In order to get a clear picture, our chief scientist Dr. Pat Gillevet was able to make some advances in next generation sequencing technology in order to categorize microbial communities. And through this profiling of microbial communities we were able to get a picture of colon polyps in colorectal cancer because of the way the polyps disrupt the microbiome.
MM: What is the concept here with how it’s developed into a commercialized product?
GK: Well, we’re ready to take our tests through the clinical validation process. We’re bringing the tests to market as a CLIA certified test initially. So we’re looking at raising series A in order to put together a roughly 1000-page clinical validation study in order to get our test commercialized. We have strong preliminary data showing sensitivity in excess of 97% with high specificity as well as high as 93%. We’re also taking the test to market in China, where we’ve recently partnered with Kind Star Diagnostics, in order to do a clinical validation study and commercialization in China.
MM: What do you anticipate the market opportunity to be?
GK: Colorectal cancer is a major problem. It’s one of the biggest cancer killers and it’s one of the most difficult to diagnose, yet if it’s caught early it can be prevented. Currently colonoscopy is the gold standard in screening, but it’s really not a good screening test. And there’s been a call for better, more sensitive screening tests in order to raise compliance and catch more cancers early where the survival rate drops drastically and costs rise dramatically. The global market for colorectal cancer screening is estimated to be $7.5 billion/year. Our test is one of those rare tests that benefits all stakeholders. It can cut healthcare costs and save lives.
MM: So you mention previously raising money for Series A in order to engage in further clinical development. Can you give me an idea of the financial structure to this date how much cash you’ve raised and how that money has been allocated?
GK: Metabiomics has been able to develop our technology platform and IP portfolio so far with all non-dilutive funding. We’ve entered into collaborative grants and contracts and developed the platform through NIH contracts and sub-awards.
MM: And this microbial DNA analysis platform has applications beyond colorectal cancer, correct?
GK: Absolutely. We actually have a pipeline of tests and we’ve taken a look at a variety of gastrointestinal maladies, including almost 4,700 different samples associating the microbiome with various GI diseases.
MM: So why does colorectal cancer jump out as the most favorable opportunity to reach markets?
GK: Really it’s because of the need for a non-invasive CRC test. IBB and IBS are also highly correlated with the microbiome dysbiosis, and we fully plan to commercialize that test as well, but we decided to highlight CRC because of the, again as I said, such a great need. It’s really a low-hanging fruit because the CRC really dramatically affects the microbiome and we’re able to detect that signature using our next generation sequencing assay.
MM: So going back to achieving success through non-dilutive financing, I’m curious if you can give me a little bit of history about how this technology was developed.
GK: Dr. Gillevet has been at George Mason University for the past 10-15 years. He’s the head of the Microbiome Analysis Center at George Mason University and he started looking at the microbiome from a microbial ecology perspective and was able to really elucidate some of the major relationships between the microbiome and health. He’s an innovator on both the next generation sequencing side in his development of a special primer set and biomarkers, and also in the analysis side, so in our advanced computational analysis platform that we’re actually coining as computational diagnostics.
MM: This particular space experiences a lot of debate with regards to what can be considered intellectual property. Can you give our listeners an understanding of why your platform can have particularly proprietary elements to it?
GK: Absolutely. Well, really our process can be protected via the method-patent route. So we have a combination of biomarker patents, which is the unique signature in the microbiome that we’re able to detect. We also have proprietary and analysis techniques that we use to discern the signature of cancer. We have two key patents so far that we will build on. The first patent is a microbiome biomarker patent that allows us to characterize colon disorders using microbial biomarkers. The second is a next generation sequencing-based patent that allows us batch process samples and really makes a big impact on our cost curve.
MM: Greg, give us an idea of cost of goods sold and manufacturing logistics.
GK: Well that’s one thing that’s remarkable about our technology platform. Our patent-pending next generation sequencing technology method allows us not only to pioneer a new target in microbiome biomarkers, it also offers disruptive cost advantages over the last generation of molecular diagnostics. We’ve actually seen a 10x reduction in operating costs due to next generation sequencing advances. And we can run 96 samples in parallel in one next generation sequencing run. We are platform agnostics (?) so we can use any machine that we like to run our assay in.
MM: So following up on that, let’s talk a little bit about ease of use on a patient level. Also why non-invasive is so important.
GK: In colorectal cancer diagnostics, it really is a big problem getting people to have their colonoscopies on a regular basis. Early detection and polyp removal has been shown to be the key to CRC survival. Yet 47% of Americans don’t comply with AMA screening recommendations and gastroenterologists often miss small polyps, which results in 60% of cancers not being detected until late-stage. Fifty five thousand deaths in the US annually and $14 billion in US healthcare costs.
We’re hoping to alleviate all those concerns by developing a highly accurate non-invasive screening test. The American Medical Association recommends colonoscopy at least once every ten years for patients who are at risk, that’s patients over age 40, and noninvasive tests every 1-2 years. Our test brings the benefit of having a highly sensitive noninvasive test, and we can do it with a stool sample. Additionally we only need a small amount of stool and we can extract the DNA from the stool sample, analyze the DNA, run our computational diagnostics assay, and return the results to our doctor or gastroenterologist within 2 working days is really what we’re aiming for.
MM: I want to explore the paradigm shift away from normative medicine towards personalized medicine. How is this affecting the general medical community and also the patient population?
GK: There are several different technologies bringing us toward personalized medicine, and the microbiome science is certainly one of them. The microbiome is every day being discovered to be related to more and more different diseases, and it also affects the way drugs are metabolized. So really if you want to get a good picture of human health and wellness, and illness, you have to look at the microbiome in addition to genomic profiles. And another reason the microbiome is interesting is it may end up being more actionable, because you can change the microbiome more easily than we can change our own genes.
MM: That was a company snapshot of Metabiomics, with Gregory Kuehn, Vice President of Business Development. Metabiomics will be a presenting company at the upcoming OneMedForum taking place June 27th in New York City. This is Matthew Margolis signing off.
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