ARCA Biopharma announces IDE submission for Gencaro test ARCA biopharma (ABIO) announced that Laboratory Corporation of America (LH) has informed ARCA that LabCorp has submitted an Investigational Device Exemption application to the U.S. FDA for the planned companion diagnostic test for Gencaro, a pharmacologically unique beta-blocker and mild vasodilator being developed for atrial fibrillation. If accepted by the FDA, the IDE will allow the companion diagnostic test to be used in the planned GENETIC-AF clinical trial. ARCA’s Gencaro Investigational New Drug application for AF has been accepted by the U.S. FDA and is active. ARCA has identified common genetic variations that it believes predict individual patient response to Gencaro, giving it the potential to be the first genetically-targeted AF prevention treatment. LabCorp and ARCA have developed the companion diagnostic test for Gencaro to identify patient genotypes based on these genetic variations of the beta-1 cardiac receptor. LabCorp will provide the patient genetic testing for ARCA’s GENETIC-AF clinical trial of Gencaro, which is expected to begin patient enrollment in the first quarter of 2014.
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