FDA-Approved Test Identifies Risk of Coronary Heart Disease

The FDA has approved the PLAC Test, a screening tool used to predict a patients risk of coronary heart disease (CHD) events like heart attacks.

The test works by measuring the activity of lipoprotein-associated phospholipase A2 (Lp-PLA2)—a biological marker for vascular inflammation—within a patients blood.
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The safety and effectiveness of the PLAC Test was evaluated in a study of 4598 participants between the ages of 45 years to 92 years. Of the participants, 58.3% were women, 41.7% were men, 41.5% were black, and 58.5% were white.

Over the course of several years, participants were followed and charted based on who manifested a CHD-related event (median follow-up was 5.3 years).

Researchers discovered that those with levels of Lp-PLA2 exceeding 225 nmol/min/mL had an increased risk of CHD events, while those with test results that were lower than that level had decreased risk.

While the test was approved for use in all adult patients, researchers found that the results were especially accurate when calculating the risk of African American 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, MD, 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,” he said.

The complete study is published on the FDA’s website.

-Michelle Canales

Reference:

US Food and Drug Administration. FDA clears test that helps predict the risk of coronary heart disease. December 15, 2014. www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm426799.htm. Accessed December 17, 2014.