March 25, 2009 - Siemens Healthcare Diagnostics’ C-reactive protein (hsCRP) test is cleared by the FDA for use as a predictor of risk for cardiovascular disease, and educational materials about the cardiac utility of the hsCRP test will be available in the company's booth (#1842) at the American College of Cardiology’s (ACC) Annual Scientific Session, March 29-31 in Orlando, FL.
The test was differentiated as the CardioPhase hsCRP test, and cleared with the cardiac-specific claim in January 2004 for use on the BN nephelometry systems. With the launch of this test on its ADVIA chemistry systems, Siemens extends use of a cardiac-specific hsCRP test across six leading-brand instrument platforms.
The JUPITER trial (Justification for the Use of statins in Primary prevention: an Intervention Trial Evaluating Rosuvastatin) specifically investigated the effect of statin therapy in apparently healthy individuals. The patients tested had low LDL cholesterol levels (2 mg/L), as determined by Siemens' BN II CardioPhase hsCRP test(1). The JUPITER trial concluded early because the statin therapy was significantly more beneficial than placebo in reducing cardiovascular morbidity and mortality by 43 percent(2).
The FDA has cleared all of Siemens' hsCRP tests for both risk assessment of future cardiovascular disease and risk stratification for the prognosis of recurrent cardiac events. When used in conjunction with traditional clinical laboratory evaluation of acute coronary syndromes, hsCRP measurements may also be useful as an independent marker of prognosis of recurrent events in patients with stable coronary disease or acute coronary syndrome.
Siemens' cardiac-specific hsCRP test is now available across multiple platforms including the BN nephelometry systems, Dimension and Dimension Vista integrated systems, the Stratus CS Acute Care Diagnostic System, ADVIA chemistry systems and the IMMULITE immunoassay systems.
(1) Glynn, MacFadyen, Ridker. Clinical Chemistry 2009; 55:2; pages 305-312.
(2) Ridker PM, et al. New England Journal of Medicine 2008; 359; pages 2195-2207.
For more information: www.siemens.com/healthcare.