Publication of Inside Information according to Article 17 MAR
Berlin, 3 May 2019 – Epigenomics AG (Frankfurt Prime Standard: ECX, OTCQX: EPGNY; the “Company”) announces that the Centers for Medicare & Medicaid Services (CMS) has accepted the company’s application for a National Coverage Determination (NCD) review of Epi proColon, Epigenomics’ blood test for colorectal cancer screening. The NCD is one of two options to obtain CMS coverage for Epi proColon, which would represent a major U.S. market breakthrough for the company. With this step, no decision has yet been made on coverage, but CMS has determined that there is a rationale to accept the NCD review at this time.
While CMS has accepted the application, due to the limitation of resources, CMS will not “Open” the NCD review process immediately. Once CMS resources are available the NCD will be “Opened” by initiating a 30-day public comment period and CMS will issue a proposed decision within six months per legal statute. If this proposed coverage decision is positive, another 30-day comment period follows. CMS will publish its final decision within 90 days of the initial proposed decision.
Epigenomics AG, Geneststrasse 5, 10829 Berlin, Tel +49 (0) 30 24345 0, Fax +49 (0) 30 24345 555, E-Mail: firstname.lastname@example.org
IR.on AG, Frederic Hilke, Tel +49 221 9140 970, E-Mail: email@example.com
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.