Source: J Am Coll Cardiol  |  Posted 6 years ago

HAYWARD, CA -- August 17, 2005 -- Adding high sensitivity C-reactive protein (hs-CRP) to routine cholesterol screening may improve cardiac health in the United States. According to a landmark study published in a recent issue of Journal of the American Medical Association, hs-CRP is as strong a predictor of cardiac risk as conventional risk factors such as cholesterol.

The study, conducted at Brigham and Women's Hospital (BWH), also showed that hs-CRP adds predictive value when used in conjunction with lipid tests related to cholesterol.

The BWH study showed that women with the highest levels of total cholesterol had twice the risk of future heart disease compared to women with the lowest levels. The research also demonstrated that women with the highest levels of hs-CRP had a three-fold increase in risk. In addition, researchers found that standard lipid measures -- in particular the ratio of total cholesterol to HDL cholesterol -- are as useful for primary risk detection as more complex lipid tests such as apolipoproteins A-1 and B100.

The study followed nearly 16,000 women aged 45 years and older for ten years and monitored for the occurrence of a first cardiovascular event.

C-reactive protein (CRP) is a systemic marker of inflammation. The hs-CRP test is used to detect low level increases in CRP in healthy individuals. These increases are due to more subtle forms of inflammation, such as inflammation in the blood vessels, and cannot be detected using conventional CRP assays.

An expanding body of research indicates that increased hs-CRP levels are associated with the development of atherosclerosis, independent of cholesterol. Atherosclerosis is now considered to be an inflammatory disorder of the blood vessels similar to how arthritis is an inflammatory disorder of the bones and joints.

Cholestech, a leading manufacturer of point of care lipid diagnostic testing devices, has received clearance from the US Food & Drug Administration to market the hs-CRP test on the Cholestech LDX(R) System for the measurement of CRP in whole blood or serum. The new test is expected to be available in the late summer of 2005.

"We endorse the scientific findings regarding the importance of using hs-CRP testing to aid in the detection of cardiac risk," said Warren E. Pinckert II, president and CEO of Cholestech. "This landmark study, coming after several other studies, reinforces the additive value of using hs-CRP along with cholesterol testing, and confirms that hs-CRP may have a dramatic impact on the detection and treatment of cardiac disease in this country."

Cholestech LDX(R) is a registered trademark and Cholestech GDX(TM) is a trademark of Cholestech Corporation. All other trademarks mentioned in this document are the property of their respective owners. For more information about Cholestech and its products, visit us on the web at http://www.cholestech.com.

SOURCE: Cholestech Corporation