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. That would include Atlanta, Charlotte, Lexington, and Nashville. With that expansion and certainly, as the ColoHealthTM test becomes available nationally, Mayer says the local lab will not be the sole processor of the test. It will be contracted out to others like Quest Diagnostics which currently runs the lab-developed test version for providers under their brand name ColoVantage™. Self-pay patients and their providers can schedule the test today by visiting ColoHealthy.com or ordering from Quest’s provider portal.
“We need to see the cancer diagnostic work to fruition,” he says but adds that the future for New Day Diagnostics is becoming a national leader in clinical trial management along with contract research.
Mayer and Jason Liggett, the company’s Chief Scientific Officer, were two of the authors of a recently published study in the Gastrointestinal Endoscopy (GIE) journal. Titled “Development of an Algorithm Combining Blood-Based Biomarkers, Fecal Immunochemical Test, and Age for Population-Based Colorectal Cancer Screening,” it was based on research undertaken in collaboration with Abbott Laboratories and Copenhagen University Hospital. First announced on the Innov865 Alliance’s “Start-up Day” stage in 2019, the research collaboration included nearly 2,000 patients verifying the clinical efficacy of New Day’s cancer biomarkers.
As we concluded the interview, Mayer teased that readers should look for an exciting new announcement soon.
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