FDA Accepts LabCorp's IDE Application for Atrial Fibrillation CDx | GenomeWeb

NEW YORK (GenomeWeb News) – Arca biopharma today said that Laboratory Corporation of America has told it that the US Food and Drug Administration has accepted LabCorp's investigational device exemption application for a companion diagnostic test for an atrial fibrillation drug under development.

The test is for use with Arca's Gencaro (bucindolol hydrochloride), a beta blocker and mild vasodilator, and the IDE allows the test to be used in a planned clinical trial for the drug.

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