NEW YORK (GenomeWeb News) – Celera today said that it has filed for US Food and Drug Administration clearance to market its KIF6 Genotyping Assay.
The Alameda, Calif.-based firm filed the Premarket Approval Application for the test to run on Abbott's m2000 molecular diagnostics instrument system. Celera's Berkeley HeartLab business currently offers a KIF6 test in the US as a laboratory-developed test.
The KIF6 test is used to detect a variant in the KIF6 gene that the may be used in conjunction with clinical evaluation and patient assessment for identifying individuals at risk for coronary heart disease, and in patients for whom statin treatment is being considered.
In June 2010, Celera applied the CE Mark to the test allowing it to be marketed throughout the European Union and other countries that recognize the CE Mark. It followed that action in September with a license granted to Abbott to exclusively distribute the KIF6 test for use on the m2000 instrument system in those countries that recognize the CE Mark, but not in the US.
Celera noted that more than 870 of Abbott's m2000 systems have been placed in laboratories worldwide.