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How Univ. of Utah Spinout Episona Is Taking On Male Fertility Testing

Story by Benjamin F. Kuo

 

How do you take a new, genetic test to market, and how do you bridge the gap between research and the market? Our interview today is with Alan Horsager, the CEO of Episona (www.episona.com), a which has developed and has been offering up an epigenetic test for male fertility. Episona's technology is based on research from the Huntsman Cancer Center, University of Utah and University of Southern California, and one of the company's co-founders is Douglas Carrell, a Professor at the University of Utah. (a version of this was also published on our sister site in Southern California.)

s What is Episona?

Alan Horsager: We are an epigenetics data company. First and foremost, we're focused on reproductive health. Our first product is called Seed, which is a screening test for male infertility. The way it works, is we look for epigenetic abnormalities in sperm, DNA, and DNA methylation, which is broadly related to fertility and embryo development. We have done both retrospective proof-of-concept and also prospective studies to prove out the concept, which is based on probably 100 papers worth of articles published in scientific journals. There's a lot of foundational science here. We've translated that into a screening test, which started offering out in October of last year.

Where was the technology for this developed?

Alan Horsager: This was developed at the University of Utah and the University of Southern California. Two of our founders are from those schools. I also have a visiting appointment at USC. The two other co-founders, one at USC and the other at the University of Utah are professors at those universities. They're not operating at the company, although they are still co-founders.

How did you decide to turn this into a company?

Alan Horsager: Andrew Smith, who is at USC and I knew each other, as we'd collaborated on some other academic projects together. I had asked him what other things he was working on in epigenetics. He mentioned his work on sperm, and I thought it was interesting, so we dug into it a little bit. We found that a fair amount of work in the reproductive space was being done by Doug Carrell. The more the three of us talked about it, the more interested we became in how epigenetics could inform human health and disease. It made a lot of sense to start looking first at sperm DNA and reproduction, because much of the data out there was in the area. That's essentially how it started.

When did you roll out your tests?

Alan Horsager: We started selling the test in October last year, when we launched at the American Society for Reproductive Medicine, at their annual conference. We've been selling it every since, and have several dozen clinics that are now offering the test now. Things are good, and moving in the right direction.

Let's talk a bit about diagnostic tests like this. For those who aren't familiar with the process, how is it that you're able to go to market so quickly with something like this without having to deal with a long FDA review?

Alan Horsager: In the genetic testing world, most companies are CLIA (Editor's note: Clinical Laboratory Improvement Amendments) certified. That means, if you do a test in a single laboratory, you can get the designation of a lab developed test, which is regulated under the Clinical Laboratory Improvement Amendment, part of Medicare. The onus for us is really about the technical validation of the assay. Is it repeatable, is it stable? The clinical utility is left up to the clinician. The requirement is that it's a physician ordered test. You can't go selling it on the street corner, which is pretty true of most diagnostic tests, particularly in the genetics space. If you look at Counsyl or Good Start and other carrier screening companies, they are all essentially lab developed tests, which are physician ordered, and regulated by the CLIA.

What's the biggest challenge you've had in bringing this product to market?

Alan Horsager: We've been pretty lucky, as things have been pretty smooth. I think the thing that is hard, is getting people to recognize how this product impacts their practice. It's getting a clinician to understand how to use the information. To frame that, to date, there's been a big bias in reproductive medicine on the female. Most of the energy has gone to understanding the problems a female might have, and where the focus has been as the source of a couple's infertility. However, 50 percent of infertility is on the male side. Not all of that manifests itself in semen analysis, as a low count or poor motility. There's many other problems. It's a side of the equation that is not well addresses. It's about how to educate the importance of that, and get them to recognize how the information fits into their treatments.

Let's talk about the recent funding round?

Alan Horsager: The funding originally started with a convertible note, through the Pasadena Angels. We then got some additional funding, of essentially high net worth individuals, not insittutional funds. Then, we converted that into a seed round, which is what we recently announced. Not everyone in that round was from the Pasadena Angels. The use of the proceedshas really been about ramping up commercialization and sales. We hired a VP of Sales, have been building out a sales team. The other part of it has been thinking about the platform. We've been working on an array-based platform, and are now exploring a sequencing-based platform. Those are the two big things. Our technology platform and also building out our sales.

Commercialization of research usually takes a lot of time, but you have managed to get this to market fairly quickly. Can you talk about the process and why?

Alan Horsager: Thinking about the universities as partners is very helpful. It's not just thinking of them as someone you take stuff from. That's not a good relationship. Looking at it from a partnership perspective with the university, and having some founder representation in the institutions whree the technology comes from is important. It help support you, from a research perspective, and it also helps you think about the research questions right. That's a big important part of it. It's also about helping folks think through how this is different from an academic project. Commercialization is actually a little easier with these sort of things, especially when one of the people involved is from the clinical side. People who are more aware of the clinical aspects of biotechnology and biological sciences typically understand commercialization a little better than others. Having a good partnership, and communication how commercialization occurs, and how it fits the academic process is very important. It keeps everyone on the same page, and keeps you thinking in the right way.

Finally, what's next for you, and what should we be watching?

Alan Horsager: I think I would go back to the first thing I mentioned, which is we're an epigenetics data company. We're broadly interested in how epigenetics informs human health. There are lots of opportunities beyond our current assay, and we're looking for very novel ways to provide access to that, as well.

Thanks, and good luck!