Blood Test to Screen for Coronary Heart Disease Approved by FDA

The US Food and Drug Administration (FDA) cleared a screening test which predicts a patient’s future coronary heart disease (CHD) events such as heart attacks, according to a statement.

While the test is approved for all adults with no history of heart disease, the FDA reviewed studies which demonstrated the test is best suited for 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,” Alberto Gutierrez, director of the Office of In Vitro Diagnostics and Radiological Health in the FDA’s Center for Devices and Radiological Health, said in a press release. “We hope the clearance of this test will improve preventative care and reduce CHD-related mortality and morbidity in these patients.”

The new test is called the PLAC Test for Lp-PLA2 Activity, designed by the California based diaDexus company, which measures the activity of lipoprotein associated phospholipase A₂ in a patient’s blood. The Lp-PLA2 is a biomarker in blood that indicates vascular inflammation which is associated with the buildup of plaque in the arteries. This artery buildup can lead to CHD, which the PLAC Test aims to prevent. Patients whose test results show Lp-PLA2 activity greater than 225 nmol/min/mL are at increased risk for CHD. If test results are lower than 225 nmol/min/mL, patients are at a decreased risk for CHD events.

The FDA’s approval was based on a sub study of the National Institutes of Health’s national Reasons for Geographic and Racial Differences in Stroke study. The study included 4,598 patients targeted based on gender and race who were aged 45 to 92 years with no history of CHD. The study cohort consisted of 41.7 percent men, 58.3 percent women, 41.5 percent blacks, and 58.5 percent whites. The patients in the longitudinal study were observed for several years (median 5.3 years) to determine which patients experienced CHD related events. Participants whose test results were higher than 225 nmol/min/mL had a CHD event rate of 7 percent, while patients whose test results were below that level had a CHD rate of 3.3 percent.

The FDA requested further subgroup analysis, including black women, because the study demonstrated a strong correlation between black women and the rate of CHD events compared to other participants in the study whose test results were higher than 225 nmol/min/mL.

The test labeling will reflect different performance data for black women, black men, white women, and white men.

The US Centers for Disease Control and Prevention acknowledged the leading cause of death is heart disease for people of most races — blacks, Hispanics, and whites are all at risk. There is also no difference between CHD event risk between men and women. Most importantly, nearly two thirds of women and half of men who die suddenly of CHD demonstrate no prior symptoms.