Test Predicts Cardiovascular Disease Risk

The test has been cleared by the U.S. Food and Drug Administration (FDA) for both risk assessment of cardiovascular disease and risk stratification for the prognosis of recurrent events.

Dade Behring (Deerfield, IL, USA) has launched the cardiac-specific CardioPhase hsCRP test on the company's Dimension integrated chemistry and immunochemistry systems. In addition, a CardioPhase hsCRP is expected to be launched on Dade Behring's Stratus CS acute care platform in 2006.

‘The number of patients diagnosed with cardiovascular disease continues to increase and it remains the number one health threat worldwide,” said Jim Reid-Anderson, chairman, president and CEO of Dade Behring. The company "is committed to addressing this trend and providing clinicians with more options to better manage and assess cardiovascular disease, thus improving patient treatment.”

According to a guidance document released by the FDA, not all high sensitivity CRP tests are cleared to identify and assess patients at risk for future cardiovascular disease. Both of Dade Behring's CardioPhase hsCRP tests are cleared for assessment of individuals at risk for future cardiovascular disease. When used in conjunction with traditional clinical laboratory evaluation of acute coronary symptoms, CardioPhase hsCRP measurement may also be useful as an independent marker of prognosis of recurrent events in patients with stable coronary disease or acute coronary symptoms.

Dade Behring offers a full line of tests that aid in the diagnosis of all stages of coronary disease. Its portfolio of cardiac tests can be run on multiple instrument platforms used in either the clinical laboratory or the point-of-care setting.



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