EQS-News

Epigenomics Initiates prospective multi-center clinical trial for “Next-Generation” blood-based colorectal cancer test

EQS-News: Epigenomics AG / Key word(s): Study Epigenomics Initiates prospective multi-center clinical trial for “Next-Generation” blood-based colorectal cancer test 19.09.2022 / 07:00 CET/CEST The issuer is solely responsible for the content of this announcement. Epigenomics Initiates prospective multi-center clinical trial for “Next-Generation” blood-based colorectal cancer test

• First subject has been enrolled in the Company’s CRC-DRAW trial
• Data to be used as basis for planned PMA submission to FDA

Berlin (Germany) and San Diego, CA (U.S.A.), September 19, 2022 - Epigenomics Inc, a wholly-owned subsidiary of Epigenomics AG (Frankfurt Prime Standard: ECX, OTCQX: EPGNY; the "Company"), today announced it has enrolled its first subject in a new pivotal clinical trial supporting the Company’s “Next-Generation” blood-based diagnostic screening test for the detection of colorectal cancer (CRC).

The prospective, multi-center study titled CRC-DRAW (CRC-Detection Reliable Assessment With Blood) will enroll screening eligible participants 45 years of age and older who are at average risk for colorectal cancer.  Over the course of the trial, it is expected to enroll over 15,000 subjects to achieve the proposed statistical endpoints needed for the study.  Clinical outcomes generated from CRC-DRAW will be used to support the planned Pre-Market Approval (PMA) submission of the Company’s “Next-Generation” CRC screening test with the U.S. Food and Drug Administration (FDA).

“CRC is still the number two cause of cancer deaths in the U.S. because numerous patients remain unscreened due to barriers with access” said Greg Hamilton, CEO of Epigenomics.  “More than ever physicians need options that patients will embrace and we believe that a reliable blood-based test that is effective and affordable provides a meaningfully differentiated solution to this problem.  We have initiated our CRC-DRAW trial because we are confident the improved performance of our “Next-Gen” test will give patients, physicians and providers an easy-to-use non-invasive option that will dramatically increase screening rates and ultimately save lives.”