FDA Approves Test for Coronary Heart Disease Risk

Dec 15, 2014

The U.S. FDA cleared a new screening test that predicts a patient’s risk of future coronary heart disease (CHD) events, such as heart attacks.

FDA cleared the test for use in all adults with no history of heart disease, but studies submitted by the company and reviewed by the FDA show that the test is better at discerning this risk in women, particularly black women.

“A cardiac test that helps better predict future CHD risk in women, and especially black women, may help health care professionals identify these patients before they experience a serious CHD event, like a heart attack,” said Alberto Gutierrez, director of the Office of In Vitro Diagnostics and Radiological Health in the FDA’s Center for Devices and Radiological Health. “We hope the clearance of this test will improve preventative care and reduce CHD-related mortality and morbidity in these patients.”

The PLAC Test for Lp-PLA2 Activity measures the activity of lipoprotein-associated phospholipase A2 (Lp-PLA2) in a patient’s blood. Lp-PLA2is a biological marker for vascular inflammation, a condition associated with the buildup of plaque in the arteries that supply blood to the heart. Over time, this buildup can result in a narrowing of the arteries and lead to CHD.

In the PLAC Test for Lp-PLA2 Activity validation study, researchers performed the test on 4,598 participants ranging in age from 45 to 92 with no history of CHD. The participants included 41.7 percent men and 58.3 percent women, and 41.5 percent blacks and 58.5 percent whites. Researchers followed the participants over the course of several years and recorded who experienced a CHD-related event.

The PLAC Test for Lp-PLA2 Activityis manufactured by diaDexus Inc., based in South San Francisco, California. Read the full release

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