DGAP-News

Epigenomics AG Plans to Challenge NCD Decision and Unveils Its Next Generation Liquid Biopsy Test for Colorectal Cancer Screening

DGAP-News: Epigenomics AG / Key word(s): Miscellaneous/Scientific publication Epigenomics AG Plans to Challenge NCD Decision and Unveils Its Next Generation Liquid Biopsy Test for Colorectal Cancer Screening 21.01.2021 / 10:02 The issuer is solely responsible for the content of this announcement. Epigenomics AG Plans to Challenge NCD Decision and Unveils Its Next Generation Liquid Biopsy Test for Colorectal Cancer Screening

• Company evaluating all options to challenge CMS' decision to non-cover the Epi proColon test
• New blood-based test demonstrates performance characteristics that would satisfy the latest sensitivity and specificity requirements outlined in the final National Coverage Determination (NCD) issued by CMS: Decision Memo for Screening for Colorectal Cancer - Blood-Based Biomarker Tests (CAG-00454N)

Berlin (Germany) and San Diego, CA (USA), January 21, 2020 - Epigenomics AG (Frankfurt Prime Standard: ECX, OTCQX: EPGNY; the "Company") announces that the management disagrees and is extremely disappointed with the non-coverage decision for Epi proColon as part of the NCD issued by CMS on Tuesday. While the Company was pleased to see the elimination of guideline requirements as part of the final NCD, it was disappointed that CMS chose to retain the concept of performance criteria and a fixed testing interval. Together with several professional societies such as the American Cancer Society, which outlined its concerns as part of the public comment period for the NCD, Epigenomics believes the arbitrary performance criteria in the NCD is in conflict with the scientific evidence. The company is currently evaluating all available alternatives (appeal and/or litigation) to challenge the final decision.

"Randomly selecting sensitivity, specificity, and testing interval values from various tests and assuming it will reduce CRC mortality is not the appropriate way to make evidence-based coverage decisions", said Greg Hamilton, CEO of Epigenomics AG. "By denying coverage for the only FDA approved blood test at this time, a portion of Medicare beneficiaries will needlessly die of colorectal cancer. This is especially true for underserved populations including minority groups and the impoverished."