DGAP-News: Epigenomics AG / Key word(s): Miscellaneous
CMS Still Actively Working on Proposed Decision Memo with Goal to Publish As Soon As Possible
Berlin (Germany) and San Diego, CA (USA), August 31, 2020 – Epigenomics AG (Frankfurt Prime Standard: ECX, OTCQX: EPGNY; the “Company”) announces that the Centers for Medicare & Medicaid Services (CMS) did not issue the proposed decision memo for its National Coverage Analysis (NCA) for Screening for Colorectal Cancer with Blood-Based Biomarker Tests by the statutory due date of August 28, 2020. CMS is actively working on the decision, and its goal is to publish the decision as soon as possible.
“While we are disappointed CMS did not meet its statutory timeline, we recognize the agency’s resources are stretched because of the pandemic,” said Greg Hamilton CEO of Epigenomics. “We remain confident that CMS will issue a positive proposed decision based upon the clinical evidence and are hopeful the agency will publish it as quickly as possible.”
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(R), is a blood-based screening test for the detection of colorectal cancer. Epi proColon has received approval from the U.S. Food and Drug Administration (FDA) and is currently marketed in the United States, Europe, and China and selected other countries. Epi proLung(R), a blood-based test for lung cancer detection, and HCCBloodTest, a blood-based test for liver cancer detection in cirrohtic patients, have received CE mark in Europe.
For more information, visit www.epigenomics.com.
Epigenomics legal disclaimer
This communication expressly or implicitly contains certain forward-looking statements concerning Epigenomics AG and its business. Such statements involve certain known and unknown risks, uncertainties and other factors which could cause the actual results, financial condition, performance or achievements of Epigenomics AG to be materially different from any expected results, performance or achievements expressed or implied by such forward-looking statements. Epigenomics AG is providing this communication as of this date and does not undertake to update any forward-looking statements contained herein as a result of new information, future events or otherwise.
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