COMPANY:

Epigenomics

"Epigenomics AG...has decided to restructure the Company and to significantly reduce the Company’s operations...The Restructuring is carried out to minimize the Company’s costs. In addition, this is intended to extend the time period available to the Company to secure financing for the further development of the 'Next-Gen'-test for detecting colorectal cancer (CRC)...The Company will stop the sale of Epi proColon and recall the product."

"Epigenomics Inc...announced...The new updated version of the “Next-Gen” assay, which incorporates in-licensed technology, achieved 84% sensitivity at 90% specificity and an advanced adenoma detection rate of 20% in pre-clinical testing. Results were based on a total of 241 subjects, ranging in age from 45-to-85, excluding advanced adenomas and including 70 CRC positive samples equally distributed between early (Stages 1&2) and late (Stages 3&4) stages of the disease. The Next-Gen test is a simple, easy to use, multiomics-solution that employs both DNA methylation markers with protein targets to assess an individual patient’s risk of having colorectal cancer."

"Epigenomics Inc...announced that it has licensed from The University of Texas MD Anderson Cancer Center certain patent and technology rights to biomarkers associated with colorectal cancer detection...Epigenomics intends to utilize this technology to complement its “Next-Gen” blood-based colorectal cancer screening test, which includes protein biomarkers as well as the Company’s proprietary DNA methylation markers such as Septin9."

"Epigenomics Inc...announced it has enrolled its first subject in a new pivotal clinical trial supporting the Company’s 'Next-Generation' blood-based diagnostic screening test for the detection of colorectal cancer (CRC)...The prospective, multi-center study titled CRC-DRAW (CRC–Detection Reliable Assessment With Blood) will enroll screening eligible participants 45 years of age and older who are at average risk for colorectal cancer."

"Epigenomics AG...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."

"Epigenomics AG…is appalled and vehemently disagrees with the negative, preliminary reimbursement proposal by the U.S. Centers for Medicare & Medicaid Services (CMS) in connection with the National Coverage Determination (NCD) of Epi proColon published on Friday."