Market Overview

ARCA Biopharma Announces FDA Acceptance of Gencaro Companion Diagnostic Test IDE


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.

ARCA has identified common genetic variations that it believes predict

See full press release

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