Centers for Medicare & Medicaid Services open NCD review process for Epi Pro Colon

• Opening of review process guarantees reimbursement decision within next nine months
• Results of microsimulation model published in November 2019 show competitiveness of Epi proColon compared to other currently recommended colorectal cancer (CRC) screening methods

Berlin (Germany) and San Diego, CA (USA), 02.03.2020 - Epigenomics AG (Frankfurt Prime Standard: ECX, OTCQX: EPGNY; the "Company") announces that the U.S. Centers for Medicare & Medicaid Services (CMS) have opened the 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. The opening of the review process obliges CMS by statute to take a decision on the reimbursement of Epi proColon within a maximum period of nine months.

Greg Hamilton, CEO of Epigenomics AG: "The opening of the NCD review process is a milestone for our company. For nearly four years since FDA approval of Epi proColon, there has been uncertainty as to when and whether CMS will reimburse Epi proColon. Now we know that a reimbursement decision will be made within the next nine months. We hope that the findings of the microsimulation model developed by experts at Harvard Medical School along with the key studies supporting FDA-approval of the product will result in CMS making a positive reimbursement decision."

The microsimulation model demonstrates that Epi proColon administered annually can reduce the incidence and mortality of colorectal cancer nearly equivalent or better than other approved methods. Additionally, when adherence is included as a variable in the model, the blood test can outperform all other CRC screening strategies in terms of long-term benefits including the reduction in CRC incidence and mortality rates.

With the opening of the NCD, a 30-day period for public comments begins. This comment period is part of a six-month review period during which CMS is required by legal statute to publish a proposed decision. If this proposed coverage decision is positive, another 30-day comment period follows. A final decision on the reimbursement will then be published by CMS within 90 days of the initial proposed decision.
 

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, and HCCBloodTest, a blood-based test for liver cancer detection in cirrohtic patients, have received CE mark in Europe.

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Epigenomics AG, Geneststrasse 5, 10829 Berlin, Tel +49 (0) 30 24345 0, Fax +49 (0) 30 24345 555, E-Mail:

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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.