diaDexus PLAC test for heart disease
This article was originally published in The Gray Sheet
Executive Summary
Adjunctive, predictive laboratory test for congestive heart disease receives 510(k) clearance July 18. The blood test measures the level of the enzyme lipoprotein-associated phospholipase A2, which is created by macrophages when a person has CHD, FDA explains. "An elevated PLAC test result with an LDL-cholesterol level of less than 130 mg/dL gives doctors increased confidence that patients have two-to-three times the risk of having [CHD] when compared with patients having lower PLAC test results," according to the agency. The test was developed by San Francisco-based diaDexus and GlaxoSmithKline (1"The Gray Sheet" June 10, 2002, p. 8)...