Phthisis Diagnostics' President on Translating Research into Diagnostic Products

Here's a nice interview from MD+DI with Crystal Icenhour, Ph.D., President and Chief Science Officer with Phthisis Diagnostics.

Charlottesville, VA–based startup Phthisis Diagnostics began operations in 2006 with a mission to bridge the translational gap between infectious disease research and diagnostic products that help patients. The company now has its first product on the international marketplace and it is making progress in expanding its distribution channels. Only recently, Phthisis has announced distribution agreements for its products in Latin America, Asia, and the United Kingdom. In July, the company received a second round of angel funding.
MD+DI recently had the opportunity to speak with the company’s president and chief science officer, Crystal Icenhour, PhD, who was the recent recipient of the Kauffman Outstanding Postdoctoral Entrepreneur award and our very own “40 Under 40” feature. In this Q&A, Icenhour provides an overview of her plans for the company and how she became an entrepreneur.

MD+DI: Could you explain how the different distribution agreements Phthisis Diagnostics has signed recently are helping you to tap into the global diagnostics market?

Icenhour: Our first product is a tool that clinical laboratories use for doing the downstream diagnostic but it is not a diagnostic itself. Our second product, for which we are getting ready to start clinical trials, is a clinical diagnostic. Our strategy is to get all of our international distributors in place now so that once we get [regulatory approval for] the first diagnostic, we will be able to very quickly and efficiently push that out into [a number of markets]. Actually, before we get it cleared by FDA, we will be able to introduce it into a lot of the international markets because we are able to do the CE Marking more efficiently than going through the FDA clearance process.

MD+DI: I’ve heard a lot about how the CE Mark process is generally more efficient than going through the U.S. system. I’d be interested to hear your thoughts on this.

Icenhour: For us, the CE Mark has been much more efficient than the FDA 510(k) clearance. It allows us to begin sales in Europe before we technically get our FDA clearance here in the United States. From a cash flow standpoint, that is ideal because we can begin bringing in revenue for the products. We can also begin collecting a lot more data about the product before it ever hits the U.S.-based market. There are a couple of different reasons why it has been beneficial to do that, but, right now, everybody is facing the same economic crunch. Getting revenues rolling in on each individual product as efficiently as we can is really important.

MD+DI: When you say “economic crunch,” are you referring to the global efforts to cut costs in healthcare?

Icenhour: More basic than that: we are an early stage company and we only have a certain amount of funds to carry us through. Our last round of funding was specifically invested to get us through clinical trials. If we expend those funds before we are able to make it all the way through our clinical trials without bringing in some sales revenues, that would be an issue because we don’t have unlimited resources to fund the company.

MD+DI: Another thing I was interested in relates to MD+DI’s selection of you for our “40 Under 40” features. Can you give me some background on how you became a healthcare entrepreneur at a young age?

Icenhour: To be honest, I didn’t really even think about it. I grew up in a family-run business and that was simply the way that my world existed. You see a problem, you create a solution for it and you run a company. In my case, it has been a much different industry. My family owns a truck repair shop. So I am definitely not in the same industry but the idea of working for yourself and of being able to step into a business setting wasn’t a foreign idea to me.

MD+DI: The mission of Phthisis Diagnostics is to bridge "the translational gap between infectious disease research and the patient." Could you provide some more context on how it does that?

Icenhour: A lot of my earlier days as a researcher were spent investigating things such as sugar transport pathways. Although it was very interesting, as a researcher I didn’t feel very fulfilled by that because it didn’t have an immediate or even a sometime-in-the-future impact on an actual patient who was suffering from the infectious diseases. Certainly, those questions are incredibly important and worth finding the answers to, but for me, I really wanted to be able to apply my scientific knowledge to problems and come up with some more tangible solutions to things and to actually measure the benefits that you are able to create.

Some of the technology that has been explored more thoroughly is real time PCR. It is a fairly well understood technology from the science realm but from the clinical diagnostic perspective, it is newer. I want to be able to take that basic biology understanding and be able to develop products that will solve a need, which is to diagnose patients who have different infectious diseases. That is something I have a passion for and something I think I am good at.