Celera Files for FDA OK for KIF6 Test | GenomeWeb

By a GenomeWeb staff reporter

NEW YORK (GenomeWeb News) – Celera today said that it has filed for US Food and Drug Administration clearance to market its KIF6 Genotyping Assay.

The Alameda, Calif.-based firm filed the Premarket Approval Application for the test to run on Abbott's m2000 molecular diagnostics instrument system. Celera's Berkeley HeartLab business currently offers a KIF6 test in the US as a laboratory-developed test.

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