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diaDexus gets US clearance for automated PLAC test

This article was originally published in Clinica

Executive Summary

An automated version of the PLAC Test developed by cardiovascular diagnostics specialist diaDexus has gained 510(k) clearance from the US FDA. The blood test measures levels of lipoprotein-associated phospholipase A2 (Lp-PLA2), and aids in predicting risk for both coronary heart disease and ischaemic stroke associated with atherosclerosis. The new version of the PLAC Test, based on turbidimetric immunoassay technology, is designed to run on most clinical chemistry analysers. The San Francisco, California firm says this will significantly expand the number of clinical labs and physician offices that are able to offer the test. US launch is expected in the second quarter of 2010.

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