High Sensitivity CRP Assay

A new high sensitivity test for C-reactive protein has been cleared as an independent predictor of risk for future cardiovascular and peripheral vascular disease by the U.S. Food and Drug Administration (FDA).

Called N High Sensitivity CRP, the assay is the product of Dade Behring (Deerfield, IL, USA). When used in conjunction with traditional clinical laboratory evaluation of acute coronary syndromes, the test may also be useful for risk stratification in patients with stable coronary disease or acute coronary syndromes. Experts on heart disease recommend against screening the entire population as a public health measure. However, they concluded that measurement of high sensitivity CRP is an independent marker of risk in those judged to be at intermediate risk (i.e., 10-20% risk of coronary disease over 10 years) and may be useful in determining the need for further evaluation and therapy in primary prevention of cardiovascular disease.

"Having this expanded use cleared by the FDA is key for the millions of people at risk for heart disease,” said Jim Reid-Anderson, chairman, president, and CEO, Dade Behring. "This clearance follows our earlier lead in licensing the high sensitivity CRP assay for cardiac risk assessment.”





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