ARCA biopharma Announces FDA Acceptance Of Gencaro Companion Diagnostic Test IDE
1/8/2014 9:54:24 AM
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 the U.S. Food and Drug Administration (FDA) has accepted LabCorp’s Investigational Device Exemption (IDE) application for the planned companion diagnostic test for GencaroTM (bucindolol hydrochloride), a pharmacologically unique beta-blocker and mild vasodilator being developed for atrial fibrillation (AF). The IDE allows 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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