Epigenomics Releases Performance Data on Next Generation Test

Epigenomics Releases Performance Data on Next Generation Test

• Epigenomics’ Next Generation test demonstrates 84% sensitivity in pre-clinical testing.
• Performance exceeds on-market standard of FIT testing for CRC screening.

Berlin (Germany) and San Diego, CA (U.S.A.), December 14, 2022 – Epigenomics Inc, a wholly-owned subsidiary of Epigenomics AG (Frankfurt Prime Standard: ECX, OTCQX: EPGNY; the “Company”), an oncology focused molecular diagnostics company, today 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.

“We are very pleased with the pre-clinical performance of our new multiomics-solution for CRC testing. An annual, blood-based test that outperforms FIT has the opportunity to be compelling solution for CRC screening that will drive higher screening rates and lower the mortality of this preventable disease”, said Greg Hamilton, CEO of Epigenomics. “With the increased sensitivity of the Next-Gen test we are confident that we will exceed the CMS threshold of 74% sensitivity at 90% specificity in our prospective clinical trial thus achieving Medicare reimbursement upon future FDA approval.”

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

Note on forward-looking statements

This publication expressly or implicitly contains forward-looking statements concerning Epigenomics AG and its business. These statements involve certain known and unknown risks, uncertainties and other factors that may cause Epigenomics AG’s actual results, financial condition and performance to be materially different from any future results, performance or achievements expressed or implied by such forward-looking statements. Epigenomics makes this announcement as of the date of this release and does not intend to update any forward-looking statements contained herein as a result of new information or future events or otherwise.