Test Aimed at Predicting CHD Risk Approved by FDA

The Food and Drug Administration (FDA) on Dec. 15 approved a test that predicts a person’s risk of future coronary heart disease (CHD) events, including heart attacks, by measuring the activity of lipoprotein-associated phospholipase A2 (Lp-PLA2) in a patient’s blood. While the PLAC Test for Lp-PLA2 Activity was cleared for use in all adults without a history of heart disease, the FDA pointed out that studies have shown that the test is more accurate at determining risk in women, especially black women.

According to the FDA, “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.”

“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.”

Read the FDA’s announcement.

Keywords: 1-Alkyl-2-acetylglycerophosphocholine Esterase, Biomarkers, Coronary Artery Disease, Female, Inflammation, Myocardial Infarction, Risk Factors, United States Food and Drug Administration

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