FDA approves blood test that predicts risk of coronary heart disease

Coronary heart disease (CHD) kills more than 385,000 people in the United States each year, and more than half of those who die suddenly have no previous symptoms.

A new blood test that could reduce CHD-related illness and mortality by predicting the risk of future heart disease has been cleared by the US Food and Drug Administration (FDA). The PLAC Test for Lp-PLA2 screens for cardiovascular inflammation which can lead to a build up of rupture-prone plaque and result in a heart attack or stroke.

The PLAC Test for Lp-PLA2 is designed for people with two or more risk factors for cardiovascular disease who may have hidden risk or higher risk than expected for heart attack and stroke.

Although it has been approved for use in all adults with no history of heart disease, studies submitted by diaDexus, the medical diagnostics company that developed the test, and reviewed by the FDA, show that the test is better at predicting 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," says Alberto Gutierrez, director of the Office of In Vitro Diagnostics and Radiological Health in the FDA’s Center for Devices and Radiological Health.