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FDA Clears Test to Predict Coronary Heart Disease Risk

The PLAC Test for Lp-PLA2 Activity (diaDexus Inc.) measures the activity of lipoprotein-associated phospholipase A2 (Lp-PLA2) — a biological marker for vascular inflammation — in the blood. Patients with Lp-PLA2 activity exceeding 225 nmol/minute/mL are considered to be at an increased risk for a future CHD event while patients with test results below this level have a lower risk for a CHD event, according to the news release. Currently, the test has been cleared for use in all adults with no history of heart disease, but studies indicate that the test better identifies risk in women, especially African-American women. — FDA Announcement