Berlin (Germany) and Germantown, MD (U.S.A.), August 30, 2017 – Epigenomics AG (Frankfurt Prime Standard: ECX, OTCQX: EPGNY), today announced the initiation of a Post Approval Study (PAS), Performance of Epi proColon in Repeated Testing in the Intended Use Population (PERT) – NCT03218423.
The PERT trial is being conducted in concert with the US Food and Drug Administration (FDA) following the 2016 Post Market Approval (PMA) of the blood based Epi proColon screening test for colorectal cancer. Epi proColon is intended for patients who are unwilling or unable to be screened with other methods including colonoscopy and take-home stool tests.
The trial is designed to assess the participation and performance of the Epi proColon test in consecutive years as well as the willingness of patients with a positive Epi proColon test to be referred to colonoscopy. The multi-center PERT trial is initiating at Beaumont Hospital in Royal Oak MI, Geisinger Clinic in Danville PA, West Virginia University in Morgantown WV and three additional centers of excellence within the US. The study will enroll 4,500 subjects over the next three years, with anticipated completion in 2022.
“Epi proColon meets a critical clinical need in the colorectal cancer screening landscape. One in three Americans are still unscreened despite awareness campaigns and sophisticated patient navigation systems. A blood test addresses the typical patient barriers associated with colonoscopy and stool tests,” stated Greg Hamilton, CEO of Epigenomics. “This trial will be instrumental in defining the longer-term acceptance and performance of Epi proColon. We are confident that the results will further demonstrate the value of Epi proColon in reaching the millions of eligible Americans that have not yet been screened.”
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. Epigenomics’ second product, Epi proLung®, is in development as a blood-based test for lung cancer detection.
For more information, visit www.epigenomics.com.
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