DGAP-News

Epigenomics AG Plans to Challenge NCD Decision and Unveils Its Next Generation Liquid Biopsy Test for Colorectal Cancer Screening - Seite 2

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."
 

About Epigenomics

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.