Celera 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.
Celera said that 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 the increased risk was significantly reduced with statin therapy.
Kathy Ordonez, chief executive officer of Celera, said: “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.”
Celera is a healthcare business focusing on the integration of genetic testing into routine clinical care through a combination of products and services incorporating proprietary discoveries. Berkeley HeartLab, a subsidiary of Celera, offers services to predict cardiovascular disease risk and improve patient management.
Celera also commercialises a wide range of molecular diagnostic products through Abbott and has licensed other relevant diagnostic technologies developed to provide personalized disease management in cancer.