Berlin (Germany) and Germantown, MD (U.S.A.) – Epigenomics AG (Frankfurt Prime Standard: ECX, OTCQX: EPGNY), the German-American cancer molecular diagnostics company, today announced the completion of subject enrollment into its ADMIT trial (ADherence to Minimally Invasive Testing – NCT02251782) for its non-invasive blood-based test for colorectal cancer (CRC) screening, Epi proColon®. The Company expects to announce results from this study during the second quarter of 2015.
Epigenomics has successfully completed enrollment in the ADMIT clinical trial this week. Study subjects were identified as historically non-compliant to CRC screening according to current screening guidelines by its partners, Kaiser Permanente and Geisinger Health Systems, who actively manage CRC screening programs in the U.S.A. Subjects were invited to a clinic visit and once enrolled into the trial, were randomized to either the FIT test to take home to complete and send back within six weeks, or to a blood draw for the Epi proColon® test, to be completed in the same time frame.
The trial was requested by the US Food and Drug Administration (FDA) in the context of Epigenomics’ pre-market approval (PMA) application for Epi proColon®. It was designed to compare adherence to CRC screening in subjects offered blood-based testing with Epi proColon® to stool-based testing with a fecal immunochemical test (FIT), a guideline recommended method. The primary endpoint is a statistically significant increase in adherence to testing by subjects offered the Epi proColon® test compared to subjects given the FIT test. The study’s secondary objectives include a measurement of compliance to colonoscopy in subjects with positive result for either test.
Trial results will be submitted to the FDA following data analysis after completion of the six week response window.
“We are encouraged and excited that we have reached our goal of achieving this important milestone”, stated Dr. Thomas Taapken, CEO/CFO of Epigenomics. “We thank our partners Kaiser Permanente and Geisinger Health System for their strong support in the conduct of this trial and, more than ever, we look forward to having the opportunity of offering screening eligible adults in the United States an easy, non-invasive option for regular colorectal cancer screening once we receive approval from the FDA.”
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Epigenomics (www.epigenomics.com) is a molecular diagnostics company developing and commercializing innovative products for cancer. The Company’s products enable doctors to diagnose cancer earlier and more accurately, leading to improved outcomes for patients. Epigenomics’ lead product, Epi proColon®, is a blood-based test for the early detection of colorectal cancer, which is currently marketed in Europe, has received approval by the Chinese Food and Drug Administration for China and is under regulatory review by the U.S. Food and Drug Administration (FDA). Additionally, the Company markets its tissue assay for use in lung cancer diagnosis, Epi proLung®, in Europe. The Company’s technology and products have been validated through multiple partnerships with leading global diagnostic companies and testing laboratories. Epigenomics is an international company with operations in Europe and the U.S.A.
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