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FDA clears test that helps predict risk for CHD
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The FDA today announced clearance of a new screening test that predicts a patient’s risk for future CHD events.
The agency has cleared the test for use in all adults with no history of CHD. However, studies submitted by diaDexus, Inc. and reviewed by the FDA show that the test is better at discerning CHD risk in women, particularly black women, according to a press release.
The PLAC Test for Lp-PLA2 Activity measures the activity of lipoprotein-associated phospholipase A2 (Lp-PLA2) in a patient’s blood. Patients with test results that show Lp-PLA2 activity >225 nmol/min/mL are at increased risk for a CHD event, while patients with test results below this level have decreased risk for a CHD event, according to the release.
The FDA reviewed data from the PLAC Test for Lp-PLA2 Activity study, a substudy from the NIH’s national REGARDS study. In the PLAC Test for Lp-PLA2 Activity validation study, researchers performed the test on 4,598 participants aged 45 to 92 years with no history of CHD (41.7% men, 41.5% black). Researchers followed the participants for an average of 5.3 years to record CHD-related events. Results showed that participants with test results >225 nmol/min/mL had a CHD event rate of 7%, while patients with test results <225 nmol/min/mL had a CHD event rate of 3.3%. The FDA requested data analyses of additional subgroups, including black women, which showed that black women had a greater increase in the rate of CHD events compared with other participants when Lp-PLA2 levels were >225 nmol/min/mL, according to the release.
As a result, the labeling for the test contains separate performance data for black women, black men, white women and white men.
“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, stated in the release. “We hope the clearance of this test will improve preventative care and reduce CHD-related mortality and morbidity in these patients.”