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This article was originally published in The Gray Sheet

Executive Summary

Genomic technology-based assay is under development by the Santa Clara, California firm to test for elevated levels of the enzyme lipoprotein-associated phospholipase A2 (Lp-PLA2). The enzyme exhibited a strong correlation with risk of congestive heart disease independent of other known risk factors, such as low-density lipoprotein cholesterol, in a study published in the Oct. 19 New England Journal of Medicine. The company intends to initially market the assay as a research diagnostic kit to help identify and manage patients at risk of a cardiac event, but hopes to eventually develop an FDA-approved diagnostic
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