Celera and Abbott have signed an exclusive distribution agreement to market Celera's CE-marked KIF6 in-vitro diagnostic test for use on Abbott’s CE-marked m2000 instrument system.
Under the 4-year agreement, the KIF6 test kit manufactured by Celera, will be distributed by Abbott in the European Union and other geographic areas excluding the US.
The KIF6 genotyping assay detects a genetic marker that may be used in conjunction with clinical evaluation and patient assessment for the identification of individuals at risk for coronary heart disease (CHD), and in patients for whom statin treatment is being considered.
The agreement follows the application by Celera for the CE mark in June 2010, of its real-time PCR (polymerase chain reaction) test for detection of a variant in the KIF6 gene.
Celera chief executive officer Kathy Ordonez said that they’re pleased that Abbott will commercialise their CE-marked KIF6 test outside the US as the first in-vitro diagnostic genetic product to predict risk for coronary heart disease and response to statin therapy.
Abbott Molecular Diagnostics Business head Stafford Kelly said that Celera’s KIF6 test represents the first cardiovascular assay on the m2000 system, and will provide a new test for physicians in helping them identify patients at risk of coronary heart disease.