Healthcare Industry News: Acute Coronary Syndrome
News Release - September 28, 2006
Dade Behring Launches CardioPhase(R) hsCRP Test for Use on Its Stratus(R) CS Acute Care(TM) Diagnostic SystemAddition Extends Use of a Cardiac-Specific hsCRP Test to a Near-Patient Setting
DEERFIELD, Ill.--(HSMN NewsFeed)--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 company's Stratus® CS Acute Care(TM) Diagnostic System. 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 of recurrent events.
"According to the World Health Organization, over 17 million people died of a cardiovascular disease in 2005," said Jim Reid-Anderson, Chairman, President and CEO, Dade Behring. "As a leader in cardiac testing, Dade Behring takes this global health care issue very seriously. The company continues to invest in expanding our cardiac test offering in order to better serve our clinical laboratory customers and help improve patient care provided at their institutions."
The Stratus® CS Acute Care(TM) Diagnostic System is a near-patient setting instrument, now with an expanded menu of seven tests. This menu includes: NT-proBNP, high sensitivity Troponin I, D-dimer, myoglobin, mass CK-MB, BetahcG and CardioPhase® hsCRP.
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. The test was cleared with the cardiac-specific claim in January 2004 for use on the BN(TM) nephelometry systems.
Dade Behring now offers a CardioPhase® hsCRP test on three testing platforms: BN(TM) nephelometry systems, Dimension® integrated chemistry and immunochemistry systems, and the Stratus® CS Acute Care(TM) Diagnostic System. This comprehensive portfolio provides laboratory customers with one of the most complete cardiac test menus available across multiple platforms.
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. All 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.
With a leadership position in the fast-growing cardiac testing market, Dade Behring 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 near-patient setting.
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(a) to clinical laboratories.
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.
(a) defined as less than 10% coefficient variant at the 99th percentile of a normal reference population.
Source: Dade Behring
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