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FDA Accepts LabCorp's IDE Application for Atrial Fibrillation CDx

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.

Arca said that it identified common genetic variations that may predict individual patient response to Gencaro, and it and LabCorp developed the CDx test to identify patient genotypes based on the genetic variations of the beta-1 cardiac receptor. LabCorp is providing the patient genetic testing for Arca's clinical trial called Genetic-AF, which is anticipated to begin accepting patient enrollment in the current quarter. Medtronic is collaborating with Arca on the trial.

The FDA also has accepted Arca's investigational new drug application for Gencaro for treating atrial fibrillation, the Westminster, Colo.-based biopharmaceutical said.