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Abbott launches CE-marked KIF6 diagnostic test in Europe

Wiesbaden, GermanyThursday, February 24, 2011, 10:00 Hrs  [IST]

Abbott announced the availability of the CE-marked KIF6 diagnostic test for use on the 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 treatment of patients with elevated cholesterol, for whom statin treatment is being considered.

Previous research has shown that carriers of the KIF6 risk variant (60 per cent of the population) have had significantly fewer fatal or nonfatal coronary events from statin therapy. According to Herbert Schuster, MD PhD, Geneticist and Preventive Cardiologist, Berlin, Germany, “The new pharmacogenetic KIF6 biomarker is very useful for my daily practice in cardiovascular risk factor management, particularly for patients with intermediate cardiovascular risk. 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.”

On September 22, 2010, Celera Corporation and Abbott announced their non-exclusive distribution agreement to market a CE-marked KIF6 diagnostic test for use on Abbott’s m2000 instrument system. Under the 4-year 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.

Abbott Molecular, abbottmolecular.com, is a leader in molecular diagnostics – the analysis of DNA, RNA, and proteins at the molecular level. Abbott Molecular's instruments and reagents also detect subtle but key changes in patients' genes and chromosomes. These tests have the potential for earlier detection or diagnosis, can influence the selection of appropriate therapies, and may improve monitoring of disease progression.

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.

 
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