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August 26, 2024 | Tom Ballard

It’s been a whirlwind year for New Day Diagnostics

While seeing its cancer diagnostic work to fruition, the future is becoming a national leader in clinical trial management along with contract research.

The last 12 months or so for the Knoxville-headquartered New Day Diagnostics LLC could best be described as a whirlwind of activities.

Last July, the local company then known as EDP Biotech Corporation announced that it was combining its assets with those of Boca Raton, FL-based New Day Diagnostics to form a vertically integrated force in the expedited development and commercialization of the diagnostic tests sector. As part of the integration of the assets of the two companies, EDP adopted its merger partner’s name.

Less than three weeks later, New Day Diagnostics announced an asset purchase agreement with Epigenomics AG, a Berlin, Germany-based molecular diagnostics company focused on blood testing for early detection of cancer.

We sat down recently with Eric Mayer, New Day Diagnostics President and Chief Executive Officer (CEO), and Jessica Etheridge, Marketing Director, for a review of the last 12 months and a look to the future that includes a relocation by the end of the year to the new Innovation South Building at the University of Tennessee (UT) Research Park.

“We want to take on research in a big way once we are at UT,” Mayer said.

Over the past year, he says that New Day Diagnostics has leveraged the assets of the merged companies that allowed it to expand into products. The first is called ColoHealthTM, acquired through the asset purchase agreement with Epigenomics AG which had the first, and at the time only, U.S. Food and Drug Administration (FDA)-approved blood test for the early detection of cancer.

A slightly revised lab-developed version of that test was pilot-launched locally in Knoxville in April 2024. Those wanting to be tested come to the New Day Diagnostics facility on Baum Drive to have their blood drawn. New Day is generating additional data by way of its local pilot program to amend the existing FDA approval by the end of this year.

There are plans already underway, however, to expand the geographic reach beyond the local area to anywhere within 200 miles of Knoxville this fall. Continue reading on TEKNOVATION.