New screening test predicts risk of future coronary heart disease

December 16, 2014

FDA has cleared a new screening test for the prediction of future coronary heart disease (CHD) events, such as myocardial infarction. It is cleared for use in all adults who have no history of CHD.

FDA has cleared a new screening test for the prediction of future coronary heart disease (CHD) events, such as myocardial infarction. It is cleared for use in all adults who have no history of CHD.

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Importantly, however, the test is more useful for determining the risk of future events in women, and especially in black women.

The activity of lipoprotein-associated phospholipase A2 (Lp-PLA2), a biologic marker for vascular inflammation, in a patient’s blood is measured by this new test known as the PLAC Test for Lp-PLA2 Activity (diaDexus, Inc.) Lp-PLA2 is associated with plaque buildup in the arteries, which can ultimately cause narrowing of the arteries and result in CHD. Anyone tested who is found to have Lp-PLA2 activity >225 nmol/min/mL is at increased risk for a future CHD event.

Results from the PLAC Test for Lp-PLA2 Activity were reviewed by FDA and form the basis for their decision to clear the test. A total of 4598 individuals aged from 45 years to 92 years with no history of heart disease participated in the study. Women accounted for 58.3% of the study cohort, and men accounted for 41.7%. The group also was defined racially as 41.5% black and 58.5% white.

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Study participants with test results >225 nmol/min/mL were determined to have a 7% CHD event rate, versus 3.3% for those with test results below that level. Median follow-up was 5.3 years. Data analyses of various subgroups found that black women with test results >225 nmol/min/mL had a higher jump in CHD event rate compared with others in the study.

CHD is the most common type of heart disease. It is estimated to kill more than 385,000 persons a year. Of those who die suddenly of CHD, about two-thirds of women and one-half of men have exhibited no previous symptoms.