New Report Shows CRC Screening Rates Increased When a Medically Underserved Population is Offered Epi proColon Blood Test

Berlin (Germany) and San Diego, CA (U.S.A.), May 20, 2019 – Epigenomics AG (FSE: ECX, OTCQX: EPGNY; the “Company”), a molecular diagnostics company focused on blood-based detection of cancers using its proprietary DNA methylation biomarker technology, today reported new results that underscore Epi proColon(R) colorectal cancer’s (CRC) high acceptance rate compared with stool-based screening tests in a medically underserved population in South Florida. The results were presented today in a poster session at Digestive Disease Week(R) (DDW(R)) 2019 in San Diego. Epi proColon received U.S. Food and Drug Administration approval in 2016 and is indicated for the screening of adults ages 50 years or older who have an average risk for CRC and who have been offered and have a history of non-compliance with CRC screening.

“CRC screening is known to reduce the incidence and increase survival of this deadly disease,” said Amar R. Deshpande, MD, Associate Professor of Clinical Medicine at the University of Miami and senior author on the report. “Despite its clear benefits, CRC screening in medically underserved populations is challenging due in part to its cost and accessibility. While previous studies have found low rates of uptake with stool-based screening tests, the results presented today demonstrate that a blood-based test has a high acceptance rate in this population. These findings suggest Epi proColon could help improve CRC screening rates in medically underserved populations, which is a critical step in reducing their CRC-associated risks.”

Dr. Deshpande’s colleagues presented the data today in a poster titled “Increasing uptake of colon cancer screening in a medically underserved population with the addition of blood-based testing” (Abstract #1667). Participants attended free health fairs hosted by the University of Miami Mitchell Wolfson Sr. Department of Community Service (DOCS) in South Florida, between April 2017 and April 2018. Those eligible for screening and at average risk for CRC were offered a stool-based fecal immunohistochemical test (FIT), and those who declined FIT were then offered the Epi proColon blood test. Blood samples were drawn from participants who accepted Epi proColon and sent for analysis. Participants with positive Epi proColon results were contacted by student navigators to try to facilitate colonoscopy. Key findings from the report include:

• Of 1,241 health fair attendees, 249 were eligible to participate in CRC screening.
• A total of 233 eligible participants (93.6%) elected to undergo Epi proColon screening.
• Of the 249 eligible participants, only 16 (6.4%) elected to receive a take-home FIT, of which only 1 was returned for processing.
• In free health fairs conducted in the prior year, which only offered FIT, 414 accepted FIT and 52 (12.5%) were processed.
• The authors conclude that the availability of the Epi proColon blood test resulted in a marked increase in screening uptake compared with FIT in medically underserved patients.

“Approximately one-third of Americans are not in compliance with current CRC screening recommendations,” said Greg Hamilton, Chief Executive Offer of Epigenomics AG. “Improving screening rates in this population demands new testing approaches that overcome the patient barriers that lead to non-compliance. The results presented today add to the growing body of data demonstrating a high acceptance rate of Epi proColon. We believe that the best CRC screening test is the one that gets done, and we are proud that Epi proColon is helping to reduce barriers to potentially lifesaving screening that gives patients and physicians important information that they can use to reduce CRC risks.”

About colorectal cancer (CRC)

Colorectal cancer remains a leading cause of cancer death in the United States. Although screening and early detection of colorectal cancer can save lives, about 35% of eligible U.S. patients are not being screened regularly. The unscreened population disproportionately results in 43% of new colorectal cancer cases and about 76% of colorectal cancer deaths and costs. Approximately $18 billion is spent annually on this preventable disease. Over $13 billion is spent on cases from unscreened individuals.

By increasing screening and detecting more cancers early, the costs and deaths from this disease both can be addressed.

About Epi proColon(R)

Epi proColon(R) is indicated for colorectal cancer screening in average-risk patients who are unwilling or unable to perform colorectal cancer screening by colonoscopy and stool-based methods. It is a qualitative, in vitro diagnostic blood test for CRC that uses real-time PCR to detect methylation of a target DNA sequence within the Septin 9 gene promoter; methylation of this DNA sequence is associated with the occurrence of CRC and can be detected in cell-free DNA that circulates in the plasma.

For patients, the test only requires a simple blood sample draw as part of routine healthcare provider visits. There are no dietary restrictions or alterations in medication required for the test. The sample will be analyzed at a national or regional diagnostic laboratory.

Epi proColon is recipient of the 2019 Excellence in Molecular Diagnostics by Corporate LiveWire’s Innovation and Excellence Awards.

For more information on Epi proColon, visit www.epiprocolon.com.

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, 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) and HCCBloodTest, blood-based tests for lung and liver cancer detection, has received CE mark in Europe.

For more information, visit www.epigenomics.com.

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