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Germantown Firm Receives FDA OK for Cancer Screening Test

May 13, 2016

With its US headquarters located within the Germantown Innovation Center, Epigenomics recently announced that its blood-based test for colorectal cancer screening, Epi proColon, will be available in the US.  This deal is an example of the success of a company in Montgomery County’s Business Innovation Network, specifically in the life sciences incubator, earning significant revenue from the marketplace.

   Epi proColon was recently approved by the US Food and Drug Administration and has been made available to laboratories in the United States under a joint commercialization agreement with Polymedco, Inc.

   "It's truly hard to express how proud we are when an incubator company makes it through FDA approvals and gets their product to market," said Sally Sternbach, Acting Director of Montgomery County Department of Economic Development.

   "Our most recent study showed that 99.5 percent of patients who were non-compliant to colorectal cancer screening by other methods would accept an Epi proColon blood test," said Noel Doheny, CEO of the company’s US subsidiary, Epigenomics Inc., in Germantown. "This made national availability of the method a key priority for us," he added. "With LabCorp now offering the test, this addresses immediate national availability for the patient and further demonstrates the ability of Epi proColon to become a key element of colorectal cancer screening participation."

   “We are excited that LabCorp is the first laboratory to launch Epi proColon in the United States, where we were recently FDA-approved,” said Dr. Thomas Taapken, CEO/CFO of Epigenomics. “LabCorp´s strong commitment and broad commercial capabilities will significantly contribute to the successful market penetration of our blood-based colorectal cancer screening test. We are already extremely pleased with the initial interest from the laboratory community. Together with our partner Polymedco, we are focusing our efforts on market adoption of the Epi proColon® test.”

   “Colorectal cancer is one of the most curable diseases when detected in its early stages and treated surgically,” said Dr. Mark Brecher, Chief Medical Officer for LabCorp Diagnostics. “Many people are not properly screened because they are reluctant to collect a stool sample or undergo a colonoscopy. Tested from a simple blood draw, Epi proColon is a convenient, accurate alternative for those patients who should be screened for colorectal cancer. LabCorp is committed to delivering world-class diagnostics, and Epi proColon will contribute to our mission to improve health and improve lives."

   Epigenomics is a molecular diagnostics company focused on blood-based detection of cancers using its proprietary DNA methylation biomarker technology. The company develops and commercializes diagnostic products across multiple cancer indications with high medical need. Epigenomics' lead product, Epi proColon, is a blood-based screening test for the detection of colorectal cancer. For more information, visit www.epigenomics.com.

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