New Study Published in the Journal of the National Cancer Institute Concludes that Epi proColon® is the Test of Choice for the Millions of Individuals Not Willing to Participate in FIT or Colonoscopy Screening

BERLIN and SAN DIEGO, Aug. 10, 2020 (GLOBE NEWSWIRE) — Epigenomics AG (Frankfurt Prime Standard: ECX, OTCQX: EPGNY; the “Company”) announces that a study published by the NCI-sponsored cancer intervention and surveillance modeling network (CISNET) in the Journal of the National Cancer Institute reported that by comparing the incremental cost-effectiveness of CTC, PillCam, mtSDNA (Cologuard) and mSEPT9 (Epi proColon), the study revealed that of these CRC screening alternatives annual screening with Epi proColon is cost-effective. Annual screening with Epi proColon had an incremental cost-effectiveness ratio (ICER) of $63,253 per QALYG. Other efficient strategies were CTC screening every 5 years (ICER: $1,092 per QALYG) and annual (but not every three years) mtSDNA screening (ICER: $214,974 per QALYG), which were not optimal given the willingness-to-pay threshold ($100,000 per QALYG).

Jorge Garces, President and CSO of Epigenomics AG: “CISNET microsimulation models are the gold-standard by which the American Cancer Society (ACS), United States Preventative Services Task Force (USPSTF), and other clinical societies base their guideline recommendations for CRC screening. This study supports the findings from another recent study published in Cancer Medicine and adds to the mounting evidence indicating that Epi proColon administered annually can reduce the incidence and mortality of colorectal cancer as effectively or better than other approved methods and most importantly highlights the opportunity for the Epi proColon blood test to serve as the test of choice for those currently resistant to colonoscopy and stool-based screening methods.”

The JNCI publication analyzed the clinical effectiveness and performance of various screening strategies under five different scenarios:

Screening from age 50 through 75 years in an-average risk population, with perfect adherence to screening, diagnostic follow-up and surveillance recommendations.
Assuming screening from age 45 to age 75 with outcomes presented per 1,000 45-year olds at 100% adherence.
Using the model version that was used to inform the 2016 USPSTF screening guidelines, in which screening starts at 50 years of age and does not account for the increasing incidence. 100% adherence assumed.
Assuming that 90% of the people that participated in a previous round would participate in a subsequent round, and 15% of the people that did not participate in the previous round would participate in the subsequent round. An 80% adherence to diagnostic follow-up and surveillance was assumed.
Assuming 12% of advanced adenomas and 18% of colorectal cancers are systematically missed by the mSEPT9.
Under all scenarios examined, annual Epi proColon was more cost-effective than Cologuard. The authors also conclude that ultimately, the best test is the “one that gets done”.

Greg Hamilton, CEO of Epigenomics AG: “This is an important publication as it further validates the clinical and cost-effectiveness of Epi proColon. It is also timely as we await the preliminary National Coverage Determination (NCD) from CMS later this month”.

As the JNCI authors clearly state: “A well-established microsimulation model demonstrates that for people who are unwilling to be screened with FIT or colonoscopy, annual screening with the mSEPT9 is the test of choice given its cost-effectiveness profile compared to CTC, PillCam and mtSDNA.”

Epigenomics will hold a conference call on Tuesday August 11, 2020 at 9:30am ET (3:30pm CET) to discuss the publication in more detail and answer questions. Please use the link in the Financial Calendar on the website to join the conference call.

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®, 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.

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