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.

Get the full story

This story is free
for registered users

Registering provides access to this and other free content.

Register now.

Already have an account?
Login Now.

In Nucleic Acids Research this week: transcriptome patterns of Zika-infected cells, updated Comparative Toxicogenomics Database, and more.

BMJ study says that about half of former hematology-oncology regulators now work for industry.

Science should wish PhDs who leave academia well, a Nature editorial says.

New York-based doctors announce the birth of a baby boy whose parents underwent mitochondrial transfer therapy, New Scientist reports.