FDA Clears Test to Predict Coronary Heart Disease Risk

The FDA has cleared a new screening test that predicts risk for future coronary heart disease (CHD) events, according to a press release from the agency.

The PLAC Test for Lp-PLA2 Activity (diaDexus Inc.) measures the activity of lipoprotein-associated phospholipase A2 (Lp-PLA2) — a biological marker for vascular inflammation — in the blood. Patients with Lp-PLA2 activity exceeding 225 nmol/minute/mL are considered to be at an increased risk for a future CHD event while patients with test results below this level have a lower risk for a CHD event, according to the release.

Currently, the test has been cleared for use in all adults with no history of heart disease, but studies indicate that the test better identifies risk in women, especially black women.

In considering clearance, the FDA reviewed the PLAC Test for Lp-PLA3 Activity study. In this substudy from the National Institutes of Health’s national Reasons for Geographic and Racial Differences in Stroke study, the researchers performed the test on 4,598 participants aged 45 to 92 years (41.7% men and 58.3% women; 41.5% black and 58.5% white participants) without a history of CHD.

After a median follow-up of 5.3 years, results revealed that participants with test results exceeding 225 nmol/minute/mL had a 7.0% CHD event rate vs. 3.3% for those with tests results below that level.

The FDA also requested analyses of additional subgroups, including black women. Data showed that the increase in the rate of CHD events, as compared with other participants, when Lp-PLA2 levels exceeded 225 nmol/minute/mL was higher. Consequently, labeling includes separate performance data according to race and gender.

“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, PhD, director of the Office of In Vitro Diagnostics and Radiological Health in the FDA’s Center for Devices and Radiological Health, said in the release.

“We hope the clearance of this test will improve preventative care and reduce CHD-related mortality and morbidity in these patients.”