Celera applies CE mark to real-time PCR test for detection of variant in KIF6 gene

Celera Corporation (NASDAQ:CRA) today announced that it has signed a Declaration of Conformity and applied the CE mark to a real-time PCR (polymerase chain reaction) test for detection of a variant in the KIF6 gene, allowing the test to be marketed in the European Union and other geographic areas that recognize the CE Mark.

KIF6 encodes a kinesin, a member of a family of proteins involved in microtubule-mediated intracellular transport. Previous research has shown that a variant of the KIF6 gene is associated with up to a 55% increased risk of primary and recurrent coronary heart disease (CHD) events in the placebo arms of pravastatin clinical trials, and that this increased risk was significantly reduced with statin therapy.

"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. We also expect to submit a KIF6 test for pre-market approval to the Food and Drug Administration later this year as we continue to move our pipeline of proprietary genetic tests into routine clinical practice," said Kathy Ordoñez, Chief Executive Officer of Celera.