Epigenomics AG announced 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. 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.