FDA Clears New Screening Test for CHD Event Risk

The Food and Drug Administration (FDA) has granted clearance for the PLAC Test for Lp-PLA2 Activity, a new test that predicts a patient's risk of future coronary heart disease (CHD) events.

It is approved for use in all adults with no history of heart disease. However, data reviewed by the FDA show that the test is better at determining this risk in women, especially black women. The test works by measuring the activity of lipoprotein-associated phospholipase A2 (Lp-PLA2), a biomarker for vascular inflammation associated with plaque buildup in the arteries. Test results that show Lp-PLA2 activity >225nmol/min/mL are at increased risk for a CHD event. Conversely, test results that are below this level indicate a decreased risk for a CHD event.

The FDA's clearance was supported by data from a validation study where researchers tested 4,598 participants aged 45–92 years with no CHD history. Participants were followed for a median of 5.3 years and those who experienced a CHD-related event were documented. Results showed that participants with levels >225nmol/min/mL had a CHD event rate of 7%, as compared with 3.3% in participants with levels <225nmol/min/mL.

RELATED: Atherosclerotic Cardiovascular Disease Risk Assessment

Further, the FDA requested analyses of other subgroups, including black women. Data showed black women had a greater increase in the rate of CHD events vs. other participants when Lp-PLA2 levels were >225nmol/min/mL. The test's labeling reflects the separate performance results for black women, black men, white women, and white men.

The PLAC Test for Lp-PLA2 Activity is manufactured by diaDexus, Inc.

For more information call (877) 752-2837 or visit PLACTest.com.

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