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ARCA biopharma Announces IDE Submission To FDA For Gencaro Companion Diagnostic Test


12/5/2013 9:45:30 AM

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WESTMINSTER, Colo.--(BUSINESS WIRE)--ARCA biopharma, Inc. (Nasdaq: ABIO), a biopharmaceutical company developing genetically-targeted therapies for cardiovascular diseases, today announced that Laboratory Corporation of America (LabCorp®) (NYSE: LH) has informed ARCA that LabCorp has submitted an Investigational Device Exemption (IDE) application to the U.S. Food and Drug Administration (FDA) for the planned companion diagnostic test for GencaroTM (bucindolol hydrochloride), a pharmacologically unique beta-blocker and mild vasodilator being developed for atrial fibrillation (AF). 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 (IND) application for AF has been accepted by the U.S. Food and Drug Administration (FDA) and is active.

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