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New form of diaDexus' PLAC Test

This article was originally published in Clinica

Executive Summary

A new, automated version of diaDexus' PLAC Test has gained 510(k) clearance from the US FDA. The new immunoassay is based on immunoturbidimetric technology, and is designed to run on common existing laboratory equipment. The product measures the levels of lipoprotein-associated phospholipase A2 (Lp-PLA2) in the patient's blood. Lp-PLA2 is an enzyme specific to vascular inflammation implicated in the formation of rupture-prone plaque. The PLAC Test is the only blood test cleared by the FDA to help assess the risk of both coronary heart disease and ischaemic stroke associated with atherosclerosis. Around 700,000 US patients have a stroke each year, and 87% of these are ischaemic. The updated version is manufactured for San Francisco, California-based diaDexus by Tokyo-based Denka Seiken.

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