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 that first patients have been enrolled into its ADMIT trial (ADherence to Minimally Invasive Testing) for its noninvasive blood-based test for colorectal cancer (CRC) screening, Epi proColon®.
The trial, which was requested by the US Food and Drug Administration (FDA) in the context of Epigenomics’ pre-market approval (PMA) application for Epi proColon®, will be conducted in 420 patients that have been historically non-compliant to CRC screening according to current screening guidelines. Epigenomics has partnered with two major U.S. health care systems, Kaiser Permanente and Geisinger Clinic, who actively manage CRC screening programs and who will identify the appropriate patients for the study within their managed patient populations. The trial aims to demonstrate that blood-based testing with Epi proColon® will increase compliance in CRC screening as compared to FIT stool-based testing.
Patients will be invited to a clinic visit and once enrolled into the trial, they will be randomized to either the FIT test to take home to complete and send back or to a blood draw for completion of the Epi proColon® test. The primary endpoint aims to show a statistically significant increase in CRC screening participation by the patients in the trial as measured by the completion rate of either test.
The study’s secondary objectives will comprise a measurement of compliance to colonoscopy in those patients with positive test results with Epi proColon® or FIT. Based on initial estimates, the company expects the trial to be enrolled within a few months.
“We are delighted to announce that we have started this trial hand in hand with two strong partners.” stated Thomas Taapken, CEO of Epigenomics. “Kaiser Permanente and Geisinger have access to our ideal patient populations and will help to expedite this very important step in Epi proColon’s path to approval. Colorectal cancer can be successfully treated if found early, and we believe the introduction of Epi proColon® will be crucial in reaching the 35 million eligible Americans that have not yet been screened.”
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Epigenomics (www.epigenomics.com) is a molecular diagnostics company developing and commercializing a pipeline of proprietary 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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