KIF6 Genotyping for Predicting Cardiovascular Risk and/or Effectiveness of Statin Therapy
Summary
KIF6 genotyping is considered investigational for predicting cardiovascular risk and/or the effectiveness of statin therapy. The policy states that KIF6 Trp719Arg genotyping is being evaluated as a test to predict the risk of future cardiovascular events and response to statin therapy, and that there is no strong evidence that the KIF6 protein plays a direct biologic role in atherosclerosis or coronary artery disease. In 2011 the FDA found that the data submitted for Celera's KIF6 Genotyping Assay were insufficient to demonstrate its safety and effectiveness, and it indicated that clinical utility data, possibly from a randomized controlled trial, might be required.
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