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FDA Clears Lab Test That Screens for Cardiac Event Risk

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A blood test that measures a biomarker for vascular inflammation has been cleared for use as a screening test for evaluating the risk of coronary heart disease events in adults with no history of heart disease, the Food and Drug Administration announced on Dec. 15.

Studies of the PLAC Test for Lp-PLA2 Activity, which measures the activity of lipoprotein-associated phospholipase A2 (Lp-PLA2), indicate that it is more accurate in determining risk in women, particularly black women, according to the FDA’s statement. “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,” Alberto Gutierrez, Ph.D., director of the Office of In Vitro Diagnostics and Radiological Health in the FDA’s Center for Devices and Radiological Health, said in the statement. “We hope the clearance of this test will improve preventative care and reduce CHD-related mortality and morbidity in these patients,” he added.

A test result over 225 nmol/min/mL indicates an increased risk for a cardiac event.

The FDA reviewed data from the Lp-PLA2 Activity study, a substudy from the National Institute of Health–sponsored Reasons for Geographic and Racial Differences in Stroke (REGARDS) project, which used the test in about 4,600 adults aged 45-92 years; 42% were men, 58% were women, 41.5% were black, and 58.5% were white. Over a median follow-up of 5.3 years, the rate of CHD events was 7% among those with a result that was over 225 nmol/min/mL and was about 3% among those with lower levels. Further analysis of subgroups “showed that black women experienced a higher jump in the rate of CHD events, compared with other participants when Lp-PLA2 levels were higher than 225 nmol/min/mL,” the statement said.

The manufacturer of the test is diaDexus, which defines Lp-PLA2 as a “vascular-specific inflammatory enzyme implicated in the formation of rupture-prone plaque.”

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