hsCRP test used in JUPITER trial extended across portfolio
ORLANDO, Fla., March 24 /PRNewswire/ -- According to a guidance document issued by the FDA(1), not all high sensitivity CRP (c-reactive protein) tests are cleared to identify and assess individuals at risk for future cardiovascular disease. Siemens Healthcare Diagnostics was the first company in the industry to introduce an hsCRP test cleared by the FDA with the cardiac-specific claim allowing its use as a predictor of risk for cardiovascular disease. The test was differentiated as the CardioPhase hsCRP test, and cleared with the cardiac-specific claim in January 2004 for use on the BN(TM) nephelometry systems. With the launch of this test on its ADVIA(R) 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 (<130 mg/dL), but elevated CRP levels (>2 mg/L), as determined by Siemens' BN II CardioPhase hsCRP test(2). The JUPITER trial concluded early because the statin therapy was significantly more beneficial than placebo in reducing cardiovascular morbidity and mortality by 43 percent(3).
Siemens will offer educational materials about the cardiac utility of the hsCRP test in the company's booth (#1842) at the upcoming 58th Annual Scientific Session of the American College of Cardiology (ACC) from March 29-31 in Orlando, Fla. On-site blood draws will also be offered for hsCRP testing in the Siemens' booth.
All of Siemens' hsCRP tests have been cleared by the FDA 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(R) and Dimension Vista(R) integrated systems, the Stratus(R) CS Acute Care(TM) Diagnostic System, ADVIA chemistry systems and the IMMULITE(R) immunoassay systems.
With a leadership position in the fast-growing cardiac testing market, Siemens offers a full line of tests that aid in the diagnosis of all stages of cardiovascular disease. The company's broad portfolio of cardiac tests can be run on multiple instrument platforms used in either the clinical laboratory or a point-of-care setting.
The Siemens Healthcare Sector is one of the world's largest suppliers to the healthcare industry. The company is a renowned medical solutions provider with core competence and innovative strength in diagnostic and therapeutic technologies as well as in knowledge engineering, including information technology and system integration. With its laboratory diagnostics acquisitions, Siemens Healthcare is the first integrated healthcare company, bringing together imaging and lab diagnostics, therapy, and healthcare information technology solutions, supplemented by consulting and support services. Siemens Healthcare delivers solutions across the entire continuum of care -- from prevention and early detection, to diagnosis, therapy and care. Additionally, Siemens Healthcare is the global market leader in innovative hearing instruments. The company employs around 49,000 people worldwide and operates in 130 countries. In the fiscal year 2008 (Sept. 30), Siemens Healthcare reported sales of euro 11.2 billion, orders of euro 11.8 billion, and Sector profit of euro 1.2 billion. Further information can be found by visiting http://www.siemens.com/healthcare.
(1) Guidance for Industry and FDA Staff; Review Criteria for Assessment of C-Reactive protein (CRP), High Sensitivity C-Reactive Protein (hsCRP) and Cardiac C-Reactive Protein (cCRP) Assays; U.S. Department of Health and Human Services Food and Drug Administration (FDA), Center for Devices and Radiological Health, Office of In Vitro Diagnostic Device Evaluation and Safety, Division of Chemistry and Toxicology Devices, September 22, 2005. View document on the following link http://www.fda.gov/cdrh/oivd/guidance/1246.html.
(2) Glynn, MacFadyen, Ridker. Clinical Chemistry 2009; 55:2; pages 305-312.
(3) Ridker PM, et al. New England Journal of Medicine 2008; 359; pages 2195-2207.
|SOURCE Siemens Healthcare Diagnostics|
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