11.04.2012 | 120411_Epigenomics_Press_release_fit_first_patient
Berlin, Germany, and Seattle, WA, U.S.A. – Epigenomics AG (Frankfurt Prime Standard: ECX), the German-American cancer molecular diagnostics company, today announced the start of the head-to-head comparative study of Epi proColon® with fecal immunochemical testing (FIT) for colorectal cancer detection. Meanwhile the first study subject has been enrolled.
As previously announced, the US Food and Drug Administration (FDA) has requested Epigenomics to perform a head-to-head comparative study for colorectal cancer detection through comparison with FIT for the purpose of demonstrating non-inferiority of Epi proColon® to FIT.
Site recruitment and initiation is currently ongoing with the aim of including up to 75 clinical sites. The study will compare FIT and Epi proColon® analyses for 100 subjects with confirmed cancer (post colonoscopy) and 200 asymptomatic average risk individuals (pre-colonoscopy). Epigenomics plans to complete this study in the second half of 2012 and the results will be an integral part of the company’s Modular Premarket Approval (PMA) submission to the FDA. The company already submitted the first two PMA modules and is on track to file its third and fourth modules in the second quarter and second half of 2012, respectively.
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Antje Zeise Manager IR | PR
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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 and is in development for the U.S.A. The Company’s technology and products have been validated through multiple partnerships with leading global diagnostic companies including Abbott, QIAGEN, Sysmex, and Quest Diagnostics. Epigenomics is an international company with operations in Europe and the U.S.A.
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