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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.

• Combined technologies have the potential to create a high-performance, cost-effective, blood-based CRC testing solution

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”), today 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.  The Company’s goal is to produce an annual screening test that outperforms the accuracy of FIT and can be performed by local, regional, and reference laboratories throughout the U.S.

“Epigenomics is committed to eliminating colorectal cancer and we believe we have the opportunity to create a novel cost-effective blood-based test that will play a significant role in reducing the mortality of the disease”, said Greg Hamilton, CEO of Epigenomics. 

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. HCCBloodTest, a blood test for the detection of liver cancer, have received the CE Mark for marketing in Europe.

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, Email: contact@epigenomics.com

Investor Relations
IR.on AG, Frederic Hilke, Tel +49 221 9140 970, Email: 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.

Berlin, December 14, 2022- Epigenomics Inc, a wholly-owned subsidiary of Epigenomics AG (Frankfurt Prime Standard: ECX, OTCQX: EPGNY; the “Company”) announces that today it has licensed certain patent and technology rights to biomarkers associated with colorectal cancer detection and that its “Next-Gen” assay for the detection of colorectal cancer, integrating such licensed patent and technology rights, 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, including 70 CRC positive samples representative of all four stages of the disease (Stages 1-4) equally distributed between early (Stages 1&2) and late (Stages 3&4) stages.

If the company is able to achieve similar results in its prospective clinical trial CRC-DRAW, it will exceed the CMS criteria of 74% sensitivity and 90% specificity required for Medicare reimbursement upon FDA approval.

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.