Stories of Technology, Innovation, & Entrepreneurship in the Southeast

Knoxville Business News Tennessee Mountain Scenery Background
February 20, 2023 | Tom Ballard

Knowing someone can really make a difference in business

Two members of the Board of Life Science Tennessee sealed a deal because they knew and trusted each other.

Relationships really matter. If you don’t believe it, just ask two Tennessee entrepreneurs who serve on the Board of Directors of Life Science Tennessee (LST) and have forged a partnership that came as a result, not only of their respect for each other, but evolutions in their business interests.

Eric Mayer is Chief Executive Officer (CEO) at EDP Biotech Corporation, a Knoxville-based company that was focused exclusively on early detection of colorectal cancer until it broadened its offerings to include testing as COVID-19 emerged as a significant healthcare issue in 2020. Today, those early efforts have snowballed into what Mayer describes as a “full-service diagnostic firm” that designs and runs its own clinical research trials, conducts testing for others, and deploys new tests.

“We have tripled our employment in the past two years, growing to 20 people,” he says, stretching the capacity of its current Bearden area location.

For Paul Fitzpatrick, it’s been more of an evolution. Many know him as the CEO of Chattanooga-based Advanced Catheter Therapies Inc. and the immediate Past Chair of LST. Probably not as many people know of other professional, life science-related endeavors such as serving for a number of years until 2017 on the Board of Directors of QuantuMDx Group Ltd, a United Kingdom-based company.

QuantuMDx states on its website that it “solves real-world diagnostic problems by creating multiplex PCR (polymerase chain reaction) solutions for the Point of Need, for anyone, anywhere. Our mission is to make transformative multiplex diagnostic solutions accessible to everyone, so that diseases can be detected and treated earlier.”

The company’s signature product is the Q-POCTM platform, a portable and simple to use molecular testing device for infectious diseases that delivers rapid, accurate, and actionable results using a sealed, single use test cassette that is designed to reduce contamination risk.

Last May, Fitzpatrick agreed to rejoin QuantuMDx and open its U.S. subsidiary. In so doing, he knew that QuantuMDx USA would need to secure 510(k) clearance from the U.S. Food and Drug Administration for its device.

“We knew we needed a CRO (clinical research organization), so we issued a request for proposals, and received four responses,” Fitzpatrick said, adding he was not satisfied with the responses. “We really wanted more of a boutique firm.”

Then, someone suggested EDP Biotech. He knew Mayer from their LST involvement but was not aware of the evolution of the company into a CRO that had performed 16 or 17 of these sorts of studies in the last two years, according to Mayer who told us, “We can move quickly.”

Having the familiarity with EDP Biotech’s CEO, Fitzpatrick says, “I immediately recused myself from any involvement in the evaluation,” but EDP Biotech still came out on top.

Under the partnership, Mayer says the company he leads is serving as one of the clinical sites, managing the others, performing all analytics, and providing the results to QuantuMDx USA which will then file for the 510(k).

“We are focused on COVID now but will be pursuing clearance for a full respiratory panel in 2023 to include SARS-CoV-2, Flu A and B and RSV (Respiratory syncytial virus),” Fitzpatrick says.


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