FDA Clears CAD Screening Test
Test works particularly well for black women.
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The FDA cleared a blood test for lipoprotein-associated phospholipase A2 (Lp-PLA2) to screen for heart disease risk.
The PLAC Test for Lp-PLA2 Activity -- a marker of vascular inflammation produced within atherosclerotic plaques -- was cleared for use in all adults with no history of heart disease.
But the test is best at discerning risk in women, particularly black women, the FDA announcement noted, citing its review of subgroups within the validation study.
That study in a subset of 4,598 people ages 45 to 92 without any heart disease history in the NIH Reasons for Geographic and Racial Differences in Stroke study showed that individuals above the threshold level for Lp-PLA2 were more than twice as likely to have an event (rate 7.0% versus 3.3%).
Lp-PLA2 activity greater than the threshold of 225 nmol/min/mL is considered elevated risk for a heart attack or other coronary heart disease event.
The label will show separate performance data for black women, black men, white women, and white men.
A prior meta-analysis supported that activity as distinct from the inflammatory marker C-reactive protein.
The test is manufactured by diaDexus, based in South San Francisco, Calif.
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