EQS-News: Epigenomics Initiates prospective multi-center clinical trial for Next-Generation blood-based colorectal cancer test

Epigenomics Initiates prospective multi-center clinical trial for Next-Generation blood-based colorectal cancer test

• First subject has been enrolled in the Companys CRC-DRAW trial
• Data to be used as basis for planned PMA submission to FDA

Berlin (Germany) and San Diego, CA (U.S.A.), September 19, 2022 - Epigenomics Inc, a wholly-owned subsidiary of Epigenomics AG (Frankfurt Prime Standard: ECX, OTCQX: EPGNY; the "Company"), today announced it has enrolled its first subject in a new pivotal clinical trial supporting the Companys 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.  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 Companys 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.
 

About Epigenomics

Epigenomics AG is a molecular diagnostics company focused on blood testing for the early detection of cancer. Based on its proprietary biomarker technology for the detection of methylated DNA, Epigenomics develops and markets blood tests for various cancer indications with high unmet medical need. Epigenomics' lead product is the blood test Epi proColon® for the early detection of colorectal cancer. Epi proColon is approved by the U.S. Food and Drug Administration (FDA) and is marketed in the United States and Europe as well as other selected countries.

For further information please visit www.epigenomics.com.

Contact:

Company
Epigenomics AG, Geneststrasse 5, 10829 Berlin,
Tel +49 (0) 30 24345 0, Fax +49 (0) 30 24345 555, E-mail: contact@epigenomics.com

Investor Relations
IR.on AG, Frederic Hilke, Tel +49 221 9140 970, E-mail: ir@epigenomics.com

Epigenomics legal disclaimer

This communication expressly or implicitly contains certain forward-looking statements concerning Epigenomics AG and its business. Such statements involve certain known and unknown risks, uncertainties and other factors which could cause the actual results, financial condition, performance or achievements of Epigenomics AG to be materially different from any expected results, performance or achievements expressed or implied by such forward-looking statements. Epigenomics AG is providing this communication as of this date and does not undertake to update any forward-looking statements contained herein as a result of new information, future events or otherwise.