FDA Clears Test for Coronary Heart Disease Risk

A new test cleared by the FDA will help determine a patient’s risk of coronary heart disease (CHD) events, such as a heart attack.

The FDA cleared the PLAC test for lipoprotein-associated phospholipase A2 (Lp-PLA2) activity to serve as a screening test for a patient’s risk of CHD events, according to an FDA press release. Studies on the test have shown that it works especially well for discerning that risk for women, and black women in particular.

If the LpPLA2 activity in a patient’s blood registers >225 nmol/min/mL, then the patient has a greater risk of a CHD event, according to the FDA.

Researchers used the test on 4598 individuals aged 45 to 92 years with no history of CHD and then followed the group, comprised of 41.5% black patients and 58.4% white patients, for several years to see who experienced a CHD event.

Individuals with test results >225 nmol/min/mL had a CHD event rate of 7%, compared with the 3.3% rate among patients with results below that level who experienced a CHD event.

The data also showed that black women saw a greater jump in their rate of CHD events compared with other individuals when both groups had levels >225 nmol/min/mL.

CHD is the most common type of heart disease and is responsible for the deaths of more than 385,000 individuals annually, according to the FDA.