DGAP-News: Epigenomics AG / Key word(s): Miscellaneous
19.12.2018 / 12:59
Centers for Medicare & Medicaid Services issue official 2019 Clinical Lab Fee Schedule including Epi proColon(R)
Berlin (Germany) and San Diego, CA (U.S.A.), December 19, 2018 – Epigenomics AG (Frankfurt Prime Standard: ECX, OTCQX: EPGNY) today announced that the Centers for Medicare & Medicaid Services (CMS) have issued its official 2019 Clinical Lab Fee Schedule (CLFS) on December 14, 2018, including the final reimbursement rate of $192 for Epi proColon(R), the first and only FDA-approved blood test for colorectal cancer screening. Epigenomics is confident that this new rate, which is a 130% increase from the originally published Medicare rate of $83.67 in 2017, will lead to increased sales in 2019. Epigenomics will provide 2019 guidance on the next earnings call, which will take place on March 27, 2019, on the occasion of the 2018 full-year results. The finalization of the rate increase is another important step for Epigenomics on its way to reimbursement, as per Protecting Access to Medicare Act (PAMA) regulations the rate of $192 per test will remain unchanged for at least three years.
Epigenomics gives update on the Donald Payne Sr. Colorectal Cancer Detection Act
Furthermore, Epigenomics has briefed the CBO (Congressional Budget Office) on HR 6919, the Donald Payne Sr. Colorectal Cancer Detection Act, and provided additional information about the colorectal screening market. There is no formal estimate on the CBO score at this time, but we will continue to provide updates if new information becomes available.
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 test for lung cancer detection, and HCCBloodTest, a test for liver cancer, have received CE mark in Europe.
For more information, visit www.epigenomics.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 future 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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