Celera Corporation and Abbott 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.

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 US. 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 per cent 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 US 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 gonorrhoea.

The association between KIF6 and event reduction during pravastatin (Pravachol) therapy has been demonstrated previously in three prospective, placebo-controlled randomized clinical trials on the prevention of CHD events: the secondary prevention Cholesterol and Recurrent Events (CARE) study; the primary prevention West of Scotland Coronary Prevention Study (WOSCOPS); and the PROspective Study of Pravastatin in the Elderly at Risk (PROSPER) study. Additionally, a genetic study of PROVE IT?TIMI 22 reported that in patients who experienced an acute coronary syndrome (ACS), high-dose atorvastatin (Lipitor), compared with standard dose pravastatin, was significantly more effective at reducing CHD events in KIF6 carriers than in noncarriers. To date, the benefits of statin therapy for KIF6 carriers has only been demonstrated with atorvastatin and pravastatin therapy.

The KIF6 gene variant has also been reported to predict risk of CHD in prospective population genetic studies. This gene variant was associated with increased risk of CHD in Caucasian and African American participants of the Atherosclerosis Risk in Communities (ARIC) study (a study of 13,907 middle aged Americans), and with increased risk for myocardial infarction (MI) in both the Cardiovascular Health Study (a study of 4,522 Americans, aged 65 or older), and the Women’s Health Study (a study of 25,283 women older than 45 years without a previous history of CHD). Thus, this KIF6 gene variant has been investigated in studies that included a total of approximately 55,000 people.

In a case-control analysis of subjects in the Ottawa Heart Study, no association was found between KIF6 and >50% coronary artery narrowing, which is a different clinical endpoint than the acute CHD event end point examined in the other KIF6 studies referenced above. Furthermore, 89% of the cases in the Ottawa Study were on statin therapy, which Celera believes may have suppressed the increased risk of KIF6 carriers.

The increased risk of CHD events observed in KIF6 carriers has been shown to be independent of other well-known CHD risk factors, including smoking, hypertension, cholesterol level, age, and sex, further supporting the conclusion that the KIF6 gene variant is an independent predictor of risk for CHD. Recently, the KIF6 protein was also shown to be expressed in atherosclerotic lesions in both mouse and human coronary arteries but not in normal arteries.

Celera is a healthcare business focusing on the integration of genetic testing into routine clinical care through a combination of products and services incorporating proprietary discoveries.

Abbott is a global, broad-based health care company devoted to the discovery, development, manufacture and marketing of pharmaceuticals and medical products, including nutritionals, devices and diagnostics.