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FDA Clears Test That Helps Predict Risk of Coronary Heart Disease
The FDA has cleared the PLAC Test for Lp-PLA2 Activity, a screening test that predicts a patient’s risk of future coronary heart disease (CHD) events, such as heart attacks.
The agency approved the test for use in all adults with no history of heart disease, but studies submitted by the manufacturer (diaDexus, Inc.) and reviewed by the FDA showed 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 Dr. 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-PLA2 is 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 narrowing of the arteries and can lead to CHD. Patients with test results that show Lp-PLA2 levels greater than 225 nmol/min/mL are at increased risk for a CHD event. Patients with test results below this level are at decreased risk for a CHD event.
According to the Centers for Disease Control and Prevention, heart disease is the leading cause of death in the U.S. for most racial/ethnic groups, including whites, blacks, and Hispanics. People of all ages and backgrounds are at risk of heart disease, and about the same number of men and women die of the disease each year. The most common type of heart disease is CHD, which kills more than 385,000 people annually. Almost two-thirds of women and half of men who die suddenly of CHD have no previous symptoms.
The FDA’s review included results from the PLAC Test for Lp-PLA2 Activity validation study, a substudy from the National Institutes of Health’s national Reasons for Geographic and Racial Differences in Stroke study, which targeted a balanced enrollment of gender and race.
In the PLAC Test for Lp-PLA2 Activity study, researchers performed the test on 4,598 participants ranging in age from 45 to 92 years with no history of CHD. The participants included 58.3% women and 41.7% men, and 58.5% whites and 41.5% blacks.
The investigators followed the participants over the course of several years and recorded who experienced a CHD-related event. The median follow-up period was 5.3 years. The study showed that participants with test results higher than 225 nmol/min/mL had a CHD event rate of 7.0%, whereas patients with test results below that level had a CHD event rate of 3.3%.
The FDA requested data analyses of additional subgroups, including black women, which showed that the latter group experienced a greater increase in the rate of CHD events compared with other participants when Lp-PLA2 levels were higher than 225 nmol/min/mL. As a result, the test’s labeling contains separate performance data for black women, black men, white women, and white men.
Source: FDA; December 15, 2014.