Gene-variant assay is Celera’s first cardiovascular diagnostic to gain CE mark.
Abbott and Celera inked an exclusive distribution agreement for the latter’s CE-marked KIF6 diagnostic test for use on Abbotts m2000™ system. Under terms of the four-year deal Celera will manufacture the test kit and Abbott will distribute it in the EU and other regions that recognize the CE mark, and worldwide excluding the U.S.
The agreement follows Celera’s application for a CE mark for the KIF6 test in June. The real-time PCR assay detects a variant in the kinesin gene KIF6 and is the first of the firm’s cardiovascular genetics products to receive European clearance. Celera claims data from the placebo arms of previous pravastatin clinical trials have shown that the gene variant correlates with up to a 55% increase in the risk of primary and recurrent coronary heart disease events, and that this risk can be reduced by administering statin therapy.
“Celera’s KIF6 test represents the first cardiovascular assay on the m2000 system, and will provide an innovative, new test for physicians in helping them identify patients at risk of coronary heart disease,” comments Stafford O’Kelly, head of molecular diagnostics at Abbott. The firm says its m2000 system offers a range of assays outside the U.S., including tests for HIV, hepatitis B and C viral load, hepatitis genotyping, cytomegalovirus, EBV, and colorectal cancer. Tests currently approved in the U.S. include those for HIV, HBV, chlamydia, and gonorrhea.