Siemens Highlights Cardiac-Specific C-Reactive Protein (hsCRP) Test at ACC 2009

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Tue Mar 24, 2009 9:01am EDT

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.

(Logo:  http://www.newscom.com/cgi-bin/prnh/20070904/SIEMENSLOGO )

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

Lance Longwell, Siemens AG, Healthcare Sector - Diagnostics Division,
+1-610-448-1477, lance.longwell@siemens.com
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