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Press release

Epigenomics AG Announces Veterans Administration’s Adherence Study using Epi proColon(R) Colorectal Cancer Screening Blood Test

Berlin (Germany) and San Diego, CA (U.S.A.), October 31, 2018 – Epigenomics AG (FSE: ECX, OTCQX: EPGNY) today announced the Veterans Administration – New York Harbor Healthcare System (VA-Manhattan) is commencing a study to assess the adherence impact of offering a blood-based colorectal cancer screening test and colonoscopy completion in patients who have refused colonoscopy and fecal immunochemical test (FIT).

The VA-Manhattan has received grants from the American Society for Gastrointestinal Endoscopy (ASGE) and New York Society for Gastrointestinal Endoscopy (NYSGE) to assist in the performance of this study. The study will be managed through The Narrows Institute. Epigenomics will provide testing and budgetary support for testing.

Colorectal cancer (CRC) is the fourth most common cancer and the second deadliest cancer in the US. However, CRC is a preventable condition with screening being one of the most impactful public health contributions to prevention. Screening rates are suboptimal due to patient barriers to colonoscopy or stool-based testing. Unscreened patients contribute to approximately 43% of new CRC cases, 70% of CRC deaths, and 76% of CRC treatment expenditures.

The goal of the VA-Manhattan study is to assess the potential of a blood-based test as an acceptable alternative for these screen-resistant individuals. If the proposed study shows high acceptance of the blood test as well as reliable colonoscopy follow up for positive tests, then the blood test could play an important adjunctive role in improving overall screening rates.

“Some people simply don’t want colonoscopy or stool-based colorectal cancer screening, so we need to understand how effective alternative methods such as a blood-based test are at engaging these individuals,” said Dr. Peter Liang, the study principal investigator and a gastroenterologist at the VA-Manhattan.

“Unscreened patients contribute significantly to new CRC cases, deaths, and treatment costs,” said Greg Hamilton, CEO of Epigenomics AG. “Addressing the unscreened challenge with a blood test could unquestionably have an impact to colorectal cancer management. We look forward to the study outcomes as they have the potential to support the use of a blood test on screening-resistant patients.”

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 test for lung cancer detection, and HCCBloodTest, a test for liver cancer, have received CE mark in Europe.

For more information, visit www.epigenomics.com.

About Narrows Institute of Biomedical Research & Education, Inc.

The Narrows Institute of Biomedical Research & Education was established to provide a flexible funding mechanism for the conduct of VA-approved research and education protocols, the Narrows Institute began in 1989 as a New York State Nonprofit Research Corporation. The mission is to support and facilitate, directly and indirectly, peer-reviewed, approved research and educational activities at the VA New York Harbor Healthcare System (VA NYHHS).

The Narrows, along with the VA NYHHS, consist of the Brooklyn, Manhattan campuses and the St. Albans Community Living Center, as well as, we are affiliated with the New York University (NYU) School of Medicine and the State University of New York (SUNY) at Downstate.

The Narrows, together with VA physicians and their staff, and others who are involved in research throughout the VA New York Harbor Healthcare System, are committed to conducting research with the highest regard for the welfare of human subjects. Learning from our predecessor’s trials and tribulations, to join forces with our colleagues, and be a champion for Veteran research throughout the Veteran communities.

Contact in the U.S.
David Bull
Director of Marketing
Phone: 240.912.6430
David.Bull@Epigenomics.com

Contact Epigenomics AG
Peter Vogt
Vice President Corporate Communication & Investor Relations
Phone +49 (0) 30 24345 386
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.

Press release

Epigenomics AG obtains CE Mark for Liquid Biopsy Test for Liver Cancer Detection

– CE Mark for liver cancer blood test enables commercialization in Europe

– Prospective U.S. trial for FDA submission to be initiated in 2019

– Investigating optimal path for CFDA approval in China

Berlin (Germany) and San Diego, CA (U.S.A.), October 29, 2018 – Epigenomics AG (FSE: ECX, OTCQX: EPGNY) today announced that it has received CE Mark for its blood test to aid in detecting liver cancer among patients with cirrhosis two months ahead of schedule. The test will be commercialized under the brand name “HCCBloodTest”. In 2019, the company plans to initiate a prospective clinical trial in the U.S. for submission to the FDA. Additionally, Epigenomics is evaluating options to expedite CFDA approval in China.

In a recently reported clinical study, the HCCBloodTest demonstrated high sensitivity of 90.6 percent at a specificity of 87.2 percent for the indication of liver cancer. Furthermore, the blood test exhibited higher diagnostic accuracy compared to alpha-fetoprotein (AFP), a widely used serum diagnostic marker for liver cancer.

According to the World Health Organization (WHO), liver cancer is the second most common cause of death from cancer worldwide with Hepatocellular carcinoma (HCC) accounting for 70-90 percent of primary liver cancers (PLC)*. A major risk-factor for developing HCC is liver cirrhosis. Globally, Epigenomics estimates the liver cirrhosis surveillance market to be in excess of 10 million tests per year making it more than a three billion Euro market opportunity globally.

In Europe, liver cirrhosis is responsible for over 170,000 deaths per year* and Epigenomics estimates approximately three million patients per year in Western Europe are eligible for liver surveillance resulting in a total available market of over one billion Euros per year. Epigenomics is currently evaluating the best potential commercial partnership opportunities for the distribution of the product.

“We are very excited about the opportunity to launch the first liquid biopsy IVD test for liver cancer”, said Greg Hamilton, CEO of Epigenomics AG. “Detecting liver cancer in cirrhosis patients represents a significant medical need worldwide. Based on the initial performance data of the test, we are moving forward with prospective clinical studies to capitalize on the opportunity to address this deadly disease.”

*Journal of Hepatology Volume 58, Issue 3 March 2013, Blachier et.al.

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, has received CE mark in Europe.

For more information, visit www.epigenomics.com.

Contact:
Epigenomics AG, Investor Relations, Peter Vogt, Geneststrasse 5, 10829 Berlin, Tel +49 (0) 30 24345 386, Fax +49 (0) 30 24345 555, 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.