Berlin (Germany) and San Diego, CA (USA), January 21, 2020 – Epigenomics AG (Frankfurt Prime Standard: ECX, OTCQX: EPGNY; the “Company”) announces that the management disagrees and is extremely disappointed with the non-coverage decision for Epi proColon as part of the NCD issued by CMS on Tuesday. While the Company was pleased to see the elimination of guideline requirements as part of the final NCD, it was disappointed that CMS chose to retain the concept of performance criteria and a fixed testing interval. Together with several professional societies such as the American Cancer Society, which outlined its concerns as part of the public comment period for the NCD, Epigenomics believes the arbitrary performance criteria in the NCD is in conflict with the scientific evidence. The company is currently evaluating all available alternatives (appeal and/or litigation) to challenge the final decision.
“Randomly selecting sensitivity, specificity, and testing interval values from various tests and assuming it will reduce CRC mortality is not the appropriate way to make evidence-based coverage decisions”, said Greg Hamilton, CEO of Epigenomics AG. “By denying coverage for the only FDA approved blood test at this time, a portion of Medicare beneficiaries will needlessly die of colorectal cancer. This is especially true for underserved populations including minority groups and the impoverished.”
Despite the egregious decision by CMS, the Company will continue to pursue a leadership position in the colorectal cancer screening market and in liquid biopsy technology. Building on its expertise in liquid biopsy and DNA methylation biomarkers, Epigenomics AG has developed and validated a new colorectal cancer screening assay with clinical performance characteristics that meet the coverage criteria outlined in the final NCD.
The interpretive algorithm for this novel assay was trained in a study with 454 samples comprising CRC patients and clinical controls. Clinical performance was then established using a total of 2,504 plasma specimens, including 136 well-characterized colorectal cancer samples, available from two independent clinical screening trials in the average-risk population. This next generation multi-target real-time PCR blood test is based on a new proprietary core DNA methylation technology. The automated assay is highly robust, providing valid results for greater than 99% of samples analyzed, and provides a fast, easy to use and affordable option for detecting CRC in a liquid biopsy.
Greg Hamilton, CEO of Epigenomics AG: “We have been working on this new technology for the past few years and are extremely excited by the data. We look forward to pursuing multiple strategic options with this new assay either as a stand-alone entity or in partnership with other key players in our industry.”
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.
For more information, visit www.epigenomics.com