Celera achieved a CE mark for its real-time PCR KIF6 variant assay, allowing the cardiovascular-disease test to be marketed throughout the EU and other regions that recognize the CE mark. The firm said it expects to submit the test to FDA later this year.
The KIF6 gene encodes a kinesin protein, and the KIF6 variant assay has been developed to help predict the risk for coronary heart disease and response to statin therapy. Celera says prospective population genetic studies have demonstrated that a variant of the KIF6 gene has been shown to increase the risk of coronary heart disease and myocardial infarction. Separate data from the placebo arm of trials evaluating the statin drug pravastatin have also confirmed that the KIF6 variant increases the risk of primary and recurrent coronary heart disease events by up to 55%, with statin therapy significantly lowering this risk, the firm points out.
“The application of the CE mark to our KIF6 test represents a significant milestone for Celera, allowing commercialization of the first in vitro diagnostic genetic product to predict risk for coronary heart disease and response to statin therapy,” comments Kathy Ordonez, Celera’s CEO.