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Knoxville, Tenn. –(Knoxville Sentinel) — 03/12/2015

Knoxville-based EDP Biotech Corp. will begin selling its blood test for early detection and monitoring of colon cancer overseas this year.

The privately-held, medical device company said it has received its CE Mark certification — or aproval to market in the European Economic Area — for its trademarked ColoMarker. The company can now market the test in 73 countries, including 27 in the European Union.

The company is also preparing to submit a packet to the Food and Drug Administration, which would tell the company what it will have to do in clinical trials to get FDA approval.

CEO Alan Jernigan said the company anticipates being ready for the U.S. market in about a year. The company has already increased personnel by 80 percent and expects to hire approximately 50 new people within the next 24 months

“One in 20 people die from colon cancer and it’s really unnecessary,” Jernigan said. “In the U.S. alone, there will be 50,000 patients who die this year. It doesn’t have to be that if there’s a convenient test to detect it early.”

ColoMarker is a blood test that detects a protein biomarker shown to exist in elevated levels in colorectal cancer patients. It is noninvasive and requires no fasting or other preparation, helping to overcome screening roadblocks.

It’s also cost effective, Jernigan said, noting the test will cost less than $100 when it hits the market.

In preclinical studies, the test has shown promising results.

“You really do need to get screened early. The challenge is the current methods on the market give people pause because they’re cumbersome or really invasive,” he said. Colonoscopies are the primary screening tool, but too many people aren’t having them, he noted. “It’s going to be a game changer,” Jernigan said. “It really does change the paradigm.”