On September 19, 2022 Epigenomics Inc, a wholly-owned subsidiary of Epigenomics AG (Frankfurt Prime Standard: ECX, OTCQX: EPGNY; the "Company"), reported 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) (Press release, Epigenomics, SEP 19, 2022, View Source [SID1234619641]).
Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:
Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing
Schedule Your 30 min Free Demo!
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. Over the course of the trial, it is expected to enroll over 15,000 subjects to achieve the proposed statistical endpoints needed for the study. Clinical outcomes generated from CRC-DRAW will be used to support the planned Pre-Market Approval (PMA) submission of the Company’s "Next-Generation" CRC screening test with the U.S. Food and Drug Administration (FDA).
"CRC is still the number two cause of cancer deaths in the U.S. because numerous patients remain unscreened due to barriers with access" said Greg Hamilton, CEO of Epigenomics. "More than ever physicians need options that patients will embrace and we believe that a reliable blood-based test that is effective and affordable provides a meaningfully differentiated solution to this problem. We have initiated our CRC-DRAW trial because we are confident the improved performance of our "Next-Gen" test will give patients, physicians and providers an easy-to-use non-invasive option that will dramatically increase screening rates and ultimately save lives."
"Epigenomics has been a long-standing pioneer in the liquid biopsy space with the first ever FDA approved cancer test from blood," said Dr. Andrew A. Lukowiak, President and Chief Scientific Officer. "We have utilized this know-how and experience to augment our previous test with additional biomarkers to significantly improve the performance. We look forward to presenting preliminary test performance data within the next couple of months."