Celera has submitted a Premarket Approval Application (PMA) to the US Food and Drug Administration (FDA) for its KIF6 Genotyping Assay, a new molecular In Vitro diagnostic (IVD) test.
The KIF6 Genotyping Assay is 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.
Celera is seeking regulatory approval to perform the KIF6 Genotyping Assay on Abbott’s m2000 instrument system.
In June 2010, 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.
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 US.
Celera CEO Kathy Ordonez said that they are pleased to have filed for regulatory approval on KIF6 Genotyping Assay in line with their year-end goal.
"This test has been designed to contribute to the prediction of risk for coronary heart disease and response to statin therapy," Ordonez said.