Abbott to commercialize Celera's CE-marked KIF6 genotyping assay outside U.S.

Sep 20 2010

Celera Corporation (NASDAQ:CRA) and Abbott (NYSE:ABT) today announced that they have signed an exclusive distribution agreement to market Celera's CE-marked KIF6 diagnostic test for use on Abbott's CE-marked m2000™ instrument system. 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.

“We believe the combination of Abbott's marketing reach, expertise in cardiovascular disease and the widespread placement of the m2000 presents a good opportunity for this test to impact the personalized treatment of cardiovascular disease.”

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. This is the first of Celera's proprietary cardiovascular genetics products to be CE marked. Under the 4-year agreement, Celera will manufacture the KIF6 test kit that Abbott will distribute in the European Union, other geographic areas that recognize the CE mark, and elsewhere worldwide, excluding the U.S. Financial details of the agreement were not disclosed.

KIF6 encodes a kinesin, a member of a family of proteins involved in microtubule-mediated intracellular transport. Previous research has shown that a variant of the KIF6 gene is associated with up to a 55% increased risk of primary and recurrent CHD events in the placebo arms of pravastatin clinical trials, and that this increased risk was significantly reduced with statin therapy.

"We're pleased that Abbott will commercialize our CE-marked KIF6 test outside the U.S. as the first in vitro diagnostic genetic product to predict risk for coronary heart disease and response to statin therapy," said Kathy Ordoñez, Chief Executive Officer of Celera. "We believe the combination of Abbott's marketing reach, expertise in cardiovascular disease and the widespread placement of the m2000 presents a good opportunity for this test to impact the personalized treatment of cardiovascular disease."

"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," said Stafford O'Kelly, head of Abbott's molecular diagnostics business.

The Abbott m2000 system offers a broad menu of assays outside the United States, including tests for HIV, hepatitis B and C viral load, hepatitis genotyping, cytomegalovirus, Epstein-Barr virus, and colorectal cancer. Tests approved in the United States include those for HIV, HBV, chlamydia and gonorrhea.