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Epigenomics AG Announces Initiation of a Prospective Clinical Study for Liver Cancer Detection

Berlin (Germany) and San Diego, CA (U.S.A.), 20 December, 2018 – Epigenomics AG (FSE: ECX, OTCQX: EPGNY) today announced the initiation of a multi-center validation and development study of its methylated cell free DNA biomarkers to aid in the detection of hepatocellular carcinoma (HCC) in patients with cirrhosis.

As an expansion of its molecular diagnostic product offering, the company recently CE marked the HCCBloodTest for cirrhotic patients at risk for HCC, based on a published clinical study, demonstrating a high sensitivity of 90.6 percent at a specificity of 87.2 percent. Furthermore, the blood test exhibited higher diagnostic accuracy compared to alpha-fetoprotein (AFP), a widely used serum diagnostic marker for liver cancer.

The company is now initiating a cross-sectional, prospective clinical trial at three medical centers to assess its methylated cell free DNA biomarkers and validate the performance of HCCBloodTest for a similar indication in the U.S. population. Key findings from this current study will bridge to a longitudinal study for FDA submission that will initiate in the second half of 2019.

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 ten 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 euro per year.

“The current methods for diagnosing the progression of liver cancer in cirrhotic patients are not perfect,” said Dr. Edward Mena, Hepatologist and Medical Director of the Pasadena Liver Center, President and CEO of California Liver Research Institute (CLRI), “and, I am optimistic that potential new biomarkers may improve outcomes in these patients.”

“We feel this important cross-sectional, prospective study of cirrhotic patients will further support the applicability of HCCBloodTest in early liver cancer detection”, said Greg Hamilton, CEO of Epigenomics AG. “Reliably detecting liver cancer is a worldwide challenge. Based on the initial performance data of the test, we have made this prospective clinical study a corporate priority.”
 

*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, and HCCBloodTest, a blood-based test for liver cancer detection in cirrhotic patients, have received CE mark in Europe.

For more information, visit www.epigenomics.com.

Contact:

Company

Epigenomics AG, Investor Relations, Geneststrasse 5, 10829 Berlin, Tel +49 (0) 30 24345 386,
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.

Centers for Medicare & Medicaid Services issue official 2019 Clinical Lab Fee Schedule including Epi proColon(R)

Berlin (Germany) and San Diego, CA (U.S.A.), December 19, 2018 – Epigenomics AG (Frankfurt Prime Standard: ECX, OTCQX: EPGNY) today announced that the Centers for Medicare & Medicaid Services (CMS) have issued its official 2019 Clinical Lab Fee Schedule (CLFS) on December 14, 2018, including the final reimbursement rate of $192 for Epi proColon(R), the first and only FDA-approved blood test for colorectal cancer screening. Epigenomics is confident that this new rate, which is a 130% increase from the originally published Medicare rate of $83.67 in 2017, will lead to increased sales in 2019. Epigenomics will provide 2019 guidance on the next earnings call, which will take place on March 27, 2019, on the occasion of the 2018 full-year results. The finalization of the rate increase is another important step for Epigenomics on its way to reimbursement, as per Protecting Access to Medicare Act (PAMA) regulations the rate of $192 per test will remain unchanged for at least three years.

Epigenomics gives update on the Donald Payne Sr. Colorectal Cancer Detection Act

Furthermore, Epigenomics has briefed the CBO (Congressional Budget Office) on HR 6919, the Donald Payne Sr. Colorectal Cancer Detection Act, and provided additional information about the colorectal screening market. There is no formal estimate on the CBO score at this time, but we will continue to provide updates if new information becomes available.
 

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.

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

Forward-Looking Statements

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 future 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.