Celera Seeks Premarket Approval for KIF6 Coronary Heart Disease Test | GenomeWeb

This article has been updated to note that the KIF6 test being submitted for regulatory approval is called the KIF6 Genotyping Assay, and not StatinCheck, which is the LDT-version of the test.

Originally published Jan. 3.

Celera this week filed a premarket approval application with the US Food and Drug Administration for its KIF6 StatinCheck genotyping test, an in vitro diagnostic for gauging the risk of coronary heart disease and statin benefit.

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