Epigenomics AG Completes U.S. Clinical Validation Study for Colorectal Cancer Blood Test Epi proColon

14-Dec-2011 - Germany

Epigenomics AG  reported the completion of the clinical validation study for its second-generation colorectal cancer blood test Epi proColon in the U.S. The study was designed to measure the clinical performance of Epi proColon for the detection of colorectal cancer in comparison to colonoscopy and is part of the required data package to seek regulatory approval of the product in the U.S. In the reported study, Epi proColon detected 68% of the colorectal cancer cases (sensitivity) while correctly identifying 80% of the patients free of disease (specificity). While the results of the study represent the lower end of the expected performance data, the findings of the study confirm the results obtained in a previously conducted clinical study with the first generation of the company’s Epi proColon test in the same cohort of patients.

Study subjects tested were selected from a prospectively collected cohort of 7.940 individuals, defined as being at average risk for colorectal cancer by current screening guidelines and who underwent colonoscopy for colorectal cancer screening. The tested study cohort included 45 cancer cases. All plasma samples selected were blinded, randomized, and tested with Epi proColon at three independent laboratories in the U.S.

After consultation with the U.S. Food and Drug Administration (FDA), the company confirmed that the clinical data would be assessed as part of the regular Premarket Approval (PMA) review process. The Company will begin the regulatory process with the FDA by submitting the first module of its PMA this month. In addition to the clinical validation study data, Epigenomics will also perform a head-to-head comparative study for colorectal cancer detection through comparison with fecal immunochemical testing (FIT) for the purpose of demonstrating non-inferiority of Epi proColon to FIT. This study will also become an integral part of the PMA submission to the FDA and is anticipated to be completed in 2012.

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