C-Reactive Protein Assay in Assessing Risk of Cardiovascular

[Guest guest]

New England Journal of Medicine Study Validates Use of Dade Berhing's High

Sensitivity C-Reactive Protein Assay in Assessing Risk of Cardiovascular Events

BOSTON, Mar 23, 2000 /PRNewswire via COMTEX/ -- A new study, published

yesterday in the New England Journal of Medicine, confirms that Dade Behring's

commercially available N High Sensitivity C-reactive protein (CRP) assay is

useful in assessing risk of cardiovascular and peripheral vascular events, such

as heart attack and stroke.

The study, C Reactive Protein and Other Markers of Inflammation in the

Prediction of Cardiovascular Disease in Women, was authored by M. Ridker,

M.D., M.P.H., cardiologist and associate professor of medicine, Harvard Medical

School and Brigham and Women's Hospital, Boston and colleagues. It affirmed the

value of high sensitivity C-reactive protein as the " strongest, univariate

predictor of the risk of cardiovascular events. "

The Dade Behring assay, cleared by the U.S. Food and Drug Administration in

November 1999, was the first test of its kind on the market at the time of

introduction. The N High Sensitivity CRP assay can detect levels of CRP in the

blood as low as 0.175mg/L, much lower than conventional C-reactive protein

assays. Dade Behring's new high sensitivity assay is highly reproducible and

demonstrates low variability.

The Harvard Medical School researchers conducted a study among 28,263 healthy

postmenopausal women over a period of three years. To assess the risk of

cardiovascular events associated with baseline levels of markers of

inflammation, results from 122 participants who suffered a cardiovascular event

were compared to the levels of 244 women who did not. Of the 12 different

markers measured in the study, high sensitivity CRP was found to be the most

significant indicator of the risk of future cardiovascular events (relative risk

of 4.4 for women in the highest quartile as compared with the lowest quartile).

The researchers' conclusions suggest that the addition of high-sensitivity CRP

to screening based on lipid levels may provide an improved method of identifying

persons at risk for cardiovascular events.

Commercial Availability

Dade Behring's assay is commercially available to physicians nationwide from

reference labs such as Quest Diagnostics Incorporated, the nation's largest

clinical laboratory company. Hospital-based physicians and independent physician

networks can currently obtain the N High Sensitivity CRP assay through Quest

Diagnostics' extensive nationwide network of laboratories and patient service

centers.

C-reactive protein

C-reactive protein is an acute-phase protein, which rises due to infection,

tissue injury, or inflammatory processes such as rheumatoid arthritis,

cardiovascular disease and peripheral vascular disease. Recent reports indicate

inflammation may be associated with atherosclerosis (fatty deposits lining walls

of blood vessels), and low levels of CRP may already be present as an indication

of atherosclerosis. The standard CRP assays, which many laboratories offer, are

not capable of detecting the low levels of CRP associated with atherosclerosis.

Clinical Studies

Over the last three years, C-reactive protein assays have been tested in a

series of large-scale prospective clinical studies(1), including the Physicians'

Health Study and the Women's Health Study, both of which demonstrated the value

of this marker in predicting risk of future heart attack, stroke, and peripheral

vascular disease in otherwise healthy men and women.

In 1997, Dr. Ridker reported that levels of C-reactive protein were elevated at

baseline among apparently healthy individuals who subsequently developed

first-ever heart attacks compared to those who did not. The men in the highest

C-reactive protein quartile had three times the risk of myocardial infarction,

two times the risk of ischemic stroke and four times the risk of developing

severe peripheral artery disease compared to the men in the lowest quartile.

Similar data were reported in 1998 concerning healthy middle-aged women.

Moreover, in both these studies, the clinical use of CRP significantly added to

the predictive value of total and HDL cholesterol. Other studies in the United

States and in Europe1 confirm the findings.

With 1999 revenues of $1.3 billion, Dade Behring is among the largest clinical

diagnostics companies worldwide, making it today's best resource by offering a

wide range of products and systems for diagnostics testing. The company is

headquartered in Deerfield, Illinois, and has operations in 40 countries.

Additional company information is available on the Internet at

www.dadebehring.com .