DGAP-News: Epigenomics AG: Centers for Medicare & Medicaid Services publish preliminary rate for Epigenomics' colorectal cancer screening test Epi proColon(R)

Press release

Centers for Medicare & Medicaid Services publish preliminary rate for Epigenomics' colorectal cancer screening test Epi proColon(R)

Medicare Administrative Contractors determine rate of $192 per test

Berlin (Germany) and Germantown, MD (U.S.A.), June 11, 2018 - Epigenomics AG (Frankfurt Prime Standard: ECX, OTCQX: EPGNY), announced that the Centers for Medicare & Medicaid Services (CMS) published a preliminary rate of $192 per Epi proColon test. Epi proColon is the first and only FDA-approved blood-based test for colorectal cancer screening.

"The new rate published by CMS is a significant milestone for the company as it appropriately values our innovative blood-based colorectal cancer screening test," said Greg Hamilton, CEO of Epigenomics AG. "Medicare pricing sets a benchmark for value and is an important component of successful commercialization."

The publication of the preliminary rate as developed by the Medicare Administrative Contractors is part of the "gapfilling" method to determine the rate for novel tests when no comparable, existing test is available.

Based on the proposed preliminary rate, CMS will determine the final rate. The publication of the final rate to be included in the 2019 Clinical Laboratory Fee Schedule is expected in November 2018.

Parallel to the CMS payment determination process, Epigenomics continues its efforts to gain coverage for Epi proColon either through a National Coverage Determination (NCD) or through legislative action by the U.S. congress.

In March 2018, Senators Shelley Moore-Capito (R -WV) and Martin Heinrich (D - NM), introduced the "Colorectal Cancer Detection Bill'' to the United States Senate in Washington D.C. This Senate Bill is parallel to House Bill (H.R. 1578) ''Donald Payne Sr. Colorectal Cancer Detection Act'' introduced by Congressman Donald M. Payne, Jr. (D - NJ). These bipartisan initiatives aim to provide coverage under the Medicare program for FDA-approved qualifying colorectal cancer screening blood-based tests.

About colorectal cancer (CRC)

Colorectal cancer remains the second-leading cause of cancer death in the United States with over 140,000 new diagnosed cases and over 50,000 deaths, annually. Regular screening and early detection of colorectal cancer can save lives: The American Cancer Society projects increasing screening rates from 65% to 80% would prevent 277,000 new cases of colorectal cancer and 203,000 deaths within 20 years.

About Epi proColon

Epi proColon is the first and only FDA-approved blood-based test indicated for colorectal cancer screening in average-risk patients who are unwilling or unable to perform colorectal cancer screening by colonoscopy and stool-based methods.

For patients, the test only requires a simple blood sample drawn as part of routine healthcare provider visits. There are no dietary restrictions or alterations in medication required for the test. The sample will be analyzed at a national or regional diagnostic laboratory.

For more information on Epi proColon, visit www.epiprocolon.com.

About Epigenomics

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, has received CE mark in Europe.

For more information, visit www.epigenomics.com.

Contact in the U.S.
David Bull
Director of Marketing
Phone: 240.912.6430
David.Bull@Epigenomics.com

Contact Epigenomics AG
Peter Vogt
Vice President Corporate Communication & Investor Relations
Phone +49 (0) 30 24345 386
ir@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.