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Abbott to Distribute Celera's KIF6 Test in EU

By a GenomeWeb staff reporter

NEW YORK (GenomeWeb News) – Celera today announced that Abbott has licensed exclusive distribution rights to the firm's CE-marked KIF6 diagnostic test for use on Abbott's m2000 instrument system in the European Union and other areas that recognize the CE mark.

Under the four-year deal, Celera will manufacture the test, which Abbott will distribute in certain markets worldwide, but excluding the US.

Alameda, Calif.-based Celera filed an application for the CE mark in June for a real-time PCR-based test for detecting a variant in the KIF6 gene that the firm said 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. Celera's Berkeley HeartLab business currently offers a KIF6 test in the US as a laboratory-developed test.

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

Outside of the US, Abbott offers several tests that run on the m2000 system, including tests for HIV, hepatitis B and C viral load, hepatitis genotyping, cytomegalovirus, Epstein-Barr virus, and colorectal cancer. In the US, the system can run tests for HIV, HBV, Chlamydia, and gonorrhea.

Financial and other terms of the alliance were not disclosed.

Abbott and Celera have an alliance covering tests to run on the m2000 system dating back to 2002. In late 2008, the firms revised the terms of that alliance, shifting from a profit-sharing arrangement to a worldwide distribution and royalty plan.

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