Healthcare Industry News:  Acute Coronary Syndrome 

Diagnostics Cardiology

 News Release - May 15, 2006

Dade Behring Launches CardioPhase(R) hsCRP Test for Use on Its Dimension(R) Systems

Addition extends use of a cardiac-specific hsCRP test to multiple testing platforms

DEERFIELD, Ill.--(HSMN NewsFeed)--May 15, 2006--Dade Behring Inc.(NASDAQ:DADE ), the world's largest company solely dedicated to clinical diagnostics and a pioneer in cardiac diagnostic testing, today announced that it has launched the cardiac-specific CardioPhase® hsCRP test on the Dimension® integrated chemistry and immunochemistry systems. This cardiac-specific high sensitivity C-reactive protein (hsCRP) test has been cleared by the FDA for both risk assessment of future cardiovascular disease and risk stratification for the prognosis of recurrent events.

Dade Behring was the first company in the industry to introduce an hsCRP test cleared by the FDA with the cardiac-specific claim allowing it to be used as a predictor of risk for cardiovascular disease. This Dade Behring CardioPhase® hsCRP test was cleared with the cardiac-specific claim in January 2004 for use on the BN(TM) nephelometry systems.

Dade Behring will now offer a CardioPhase® hsCRP test on both the BN(TM) nephelometry and Dimension® integrated chemistry and immunochemistry systems, providing customers with one of the most complete cardiac test menus available on multiple platforms. In addition, a CardioPhase® hsCRP test is expected to be launched on the Stratus® CS Acute Care(TM) platform in the second half of 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, Dade Behring.

"Dade Behring 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 issued by the FDA(1), not all high sensitivity CRP tests are cleared to identify and assess individuals at risk for future cardiovascular disease. Both of Dade Behring's CardioPhase® hsCRP tests are cleared by the FDA for assessment of individuals at risk for future cardiovascular disease. When used in conjunction with traditional clinical laboratory evaluation of Acute Coronary Syndromes, CardioPhase® 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.

Dade Behring continues to be a leader in the fast-growing cardiac testing market and offers a full line of tests that aid in the diagnosis of all stages of cardiovascular disease. In addition to Dade Behring being the first to have a cardiac-specific hsCRP test, the company's leadership position in the cardiac market is illustrated by many other key events.

Dade Behring was also the first to introduce an automated high-sensitivity CRP test and was the first to offer the Acute Care(TM) high-sensitivity Troponin I(2) to clinical laboratories. Dade Behring's broad portfolio of cardiac tests can be run on multiple instrument platforms used in either the clinical laboratory or the point-of-care setting.

About Dade Behring

With 2005 revenue of nearly $1.7 billion, Dade Behring is the world's largest company solely dedicated to clinical diagnostics. It offers a wide range of products, systems and services designed to meet the day-to-day needs of laboratories, delivering innovative solutions to customers and enhancing the quality of life for patients. Additional company information is available on the Internet at www.dadebehring.com.

(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) defined as less than 10% coefficient variant at the 99th percentile of a normal reference population.


Source: Dade Behring

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