On March 2, 2020 Epigenomics AG (Frankfurt Prime Standard: ECX, OTCQX: EPGNY; the "Company") reported 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 (Press release, Epigenomics, MAR 2, 2020, View Source [SID1234555014]). 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.

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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.