The U.S. Food and Drug Administration (FDA) cleared a new blood test that could help predict a patient's risk of future coronary heart disease (CHD) events such as heart attacks.
The test was approved for adults with no history of heart disease the FDA reported. Studies have shown the novel test is most accurate in 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," said Alberto Gutierrez, 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."
The method, dubbed the PLAC test, looks for Lp-PLA2 Activitymeasures the activity of lipoprotein-associatedphospholipase A2 (Lp-PLA2) in a patient's blood. Lp-PLA2 is a biological marker that indicates vascular inflammation caused by a buildup of plaque in the arteries. Patients found to have Lp-PLA2activity greater than the level of 225 nanomoles per minute per milliliter (nmol/min/mL) have been shown to have an elevated risk of cardiovascular events while those whose activity is below these levels have a decreased risk.
To test the method researchers looked at 4,598 participants between the ages of 45 and 92 who had no history of CHD. The patients were followed for a median period of 58.3 years and their medical events were recorded during this time.
The study found participants with test results higher than 225 nmol/min/mL had a CHD event rate of 7 percent, while those who fell below this number had a CHD event rate of 3.3 percent. Black women were found to exhibit a higher jump in CHD events compared to other participants with high Lp-PLA2 levels.
