Celera Provides Update on Recent Scientific Findings on KIF6 and PMA Application

Celera Corporation

today provided an update on recent scientific findings pertaining to the KIF6 gene variant and its pre-market approval application (

) with the United States Food and Drug Administration (FDA) for its KIF6 Genotyping Assay. In nine previously published peer-reviewed articles on genetic studies of KIF6, including 4 prospective randomized clinical trials of statin therapy (CARE, WOSCOPS, PROSPER, and PROVE IT), KIF6 carriers had greater risk for coronary heart disease (

) and received greater benefit from pravastatin therapy (or from high-dose atorvastatin compared with pravastatin in the PROVE IT trial) than did noncarriers. Two recent papers in peer-reviewed publications, and two posters presented at the annual meeting of the American College of Cardiology earlier this month, provided new information relative to KIF6 that differed in several important respects from the above-mentioned genetic studies.