Celera Corporation (NASDAQ:CRA) today announced that it has submitted a Premarket Approval Application (PMA) to the U.S. Food and Drug Administration (FDA) for its KIF6 Genotyping Assay, a new molecular In Vitro diagnostic (IVD) test designed to detect a marker for risk of coronary heart disease (CHD) independent of traditional risk factors and aid clinical evaluation when statin treatment is being considered.
“This test has been designed to contribute to the prediction of risk for coronary heart disease and response to statin therapy.”
"We're pleased to have filed for regulatory approval on our KIF6 Genotyping Assay in line with our year-end goal," said Kathy Ordoñez, Chief Executive Officer of Celera. "This test has been designed to contribute to the prediction of risk for coronary heart disease and response to statin therapy."
Celera is seeking regulatory approval to perform the KIF6 Genotyping Assay on Abbott's m2000™ instrument system. More than 870 m2000 systems have been placed in laboratories worldwide. In June 2010, Celera 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. In September 2010, Celera and Abbott signed an exclusive distribution agreement allowing Abbott to market and distribute Celera's CE-marked KIF6 diagnostic test for use on the CE-marked m2000 system in the European Union, other geographic areas that recognize the CE mark, and elsewhere worldwide, excluding the U.S.
Research on KIF6
The association between KIF6 and event reduction during pravastatin (Pravachol®) therapy has been demonstrated in three prospective, placebo-controlled randomized clinical trials of statin therapy for the prevention of CHD events: the secondary prevention Cholesterol and Recurrent Events (CARE) study; the primary prevention West of Scotland Coronary Prevention Study (WOSCOPS); and the PROspective Study of Pravastatin in the Elderly at Risk (PROSPER) study. Additionally, a genetic study of PROVE IT-TIMI 22 reported that in patients who experienced an acute coronary syndrome (ACS), high-dose atorvastatin (Lipitor®), compared with standard dose pravastatin, was significantly more effective at reducing CHD events in KIF6 carriers than in noncarriers. To date, a differential benefit of statin therapy for KIF6 carriers versus noncarriers has only been reported for atorvastatin and pravastatin therapy.
The KIF6 gene variant has also been reported to be associated with increased risk of CHD in prospective population cohort studies. This gene variant was associated with increased risk of CHD in Caucasian and African American participants of the Atherosclerosis Risk in Communities (ARIC) study of 13,907 middle aged Americans, and with increased risk for myocardial infarction (MI) in both the Cardiovascular Health Study of 4,522 Americans, aged 65 or older, and the Women's Health Study of 25,283 women older than 45 years and without a previous history of CHD.
The increased risk of CHD events observed in KIF6 carriers has been shown to be independent of other well-known CHD risk factors, including smoking, hypertension, cholesterol level, age, and sex.