By Tom Ballard, Chief Alliance Officer, PYA
If everything goes as planned, EDP Biotech Corporation expects to be selling its ColoMarker® product in Europe by the end of this year.
That’s the word from Eric Mayer, Chief Executive Officer (CEO) of the company that is located on Baum Drive in West Knoxville. After joining EDP Biotech as Vice President of Business Development in early 2013, he was named Interim CEO in June 2015 and later had the interim title removed.
“We’re a first-in-class, easy-to-use, accurate and cost-effective early test for colon cancer,” Mayer says of the ColoMarker® product. Those characteristics are important since colon cancer is the third leading cause of cancer deaths in the U.S. annually. If the cancer is detected and treated early, the survival rate is about 90 percent after five years.
The technology was initially discovered in Knoxville at a firm named JCL Laboratories. In 2005, Tom Boyd, a well-known Knoxville entrepreneur, acquired all assets of the lab including the biomarker for the colon cancer detection. He later spun-out one of the acquired technologies into a separate animal genetics company named BioPet Laboratories, also located in Knoxville.
“ColoMarker® remains our top target,” Mayer says even though EDP Biotech has other innovative technologies in its portfolio that can help with early detection. The company’s tagline – early detection products – says it all. EDP performs research and develops products to identify and purify proteins present in the early stages of biological changes for production of in vitro diagnostic tests.
Mayer describes the ColoMarker® blood-based test as a “simple liquid biopsy process”. Doctors will take a routine blood draw during a patient’s annual physical exam and send it to the reference lab for ColoMarker® testing, just like any other blood test.
What problem does EDP Biotech hope to address? It is the fact that many people are not tested due to the high cost, inconvenience, and invasiveness of current options.
“We will not replace colonoscopies,” Mayer says. Instead, the company sees its role as helping address those who are reluctant to be screened by providing a test that is more reliable than many on the market today and affordable. A confirmatory colonoscopy will remain the “gold standard,” and ColoMarker® will aid the physician in making an early diagnosis.
“We feel this is a global product,” Mayer adds, noting that the company is nearing completion of clinical research studies at six different sites in five European countries. Once those are finished and the results are known, EDP Biotech expects to begin offering the product as a tool to improve the effectiveness of national screening programs.
Acknowledging that it is much easier to launch a new biotech product in Europe rather than the U.S., Mayer says clinical trials in this country might begin in 2017 with a goal of securing U.S. Food and Drug Administration (FDA) approval to launch by the middle to end of 2019.
“That schedule could be accelerated with the right partner,” he says.
There’s also the opportunity for the underlying technology to migrate to other platforms.
Mayer brings a technical and business background to his CEO duties at EDP Biotech. After earning his undergraduate degree in biochemistry at the University of North Carolina in Chapel Hill, he earned a Micro Master’s degree in biotechnology and an MBA. Having been involved with several start-ups in Research Triangle Park and in Knoxville, he has “worn many hats.” His career includes work as a bench scientist, marketing and sales manager, and directing business development.