Coronary Heart Disease Genetic Marker Test Cleared in Europe


February 25, 2011

February 25, 2011 – A diagnostic test used to help treat patients with high cholesterol received CE mark approval in Europe. The KIF6 genotyping assay, from Abbott, 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). Often, statin treatment is being considered for these patients.

Previous research has shown that carriers of the KIF6 risk variant (60 percent of the population) have had significantly fewer fatal or nonfatal coronary events from statin therapy.

"The new pharmacogenetic KIF6 biomarker is very useful for my daily practice in cardiovascular risk factor management, particularly for patients with intermediate cardiovascular risk,” said Herbert Schuster, M.D. Ph.D., geneticist and preventive cardiologist, Berlin, Germany. “I use this marker to reclassify patients to further support individualized indication of statin therapy. In addition, carriers of the variant will significantly benefit from statin therapy and are more likely to benefit from continuous therapy."

In September 2010, Celera Corp. and Abbott announced a nonexclusive distribution agreement to market a CE-marked KIF6 diagnostic test for use on Abbott's m2000 instrument system. Under the agreement, Celera will manufacture the KIF6 test kit which Abbott Molecular will distribute in the European Union, other geographic areas that recognize the CE mark, and elsewhere worldwide, excluding the United States.

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