diaDexus (San Francisco) has received FDA clearance for a new automated version of its PLAC Test. The new PLAC Test format, based on immunoturbidimetric technology, is an automated immunoassay designed to run on common existing laboratory equipment, including clinical chemistry analyzers from Hitachi, Roche/Hitachi, and Olympus, thus expanding the number of clinical labs and physician offices able to offer the test
Patrick Plewman, president/CEO of diaDexus, said that the new format of the PLAC Test will play a key role in the company’s focus on the early detection of risk of stroke and heart disease.
The PLAC Test is a blood test that measures lipoprotein-associated phospholipase A2 (Lp-PLA2), an enzyme specific to vascular inflammation implicated in the formation of rupture-prone plaque. The new PLAC Test format is manufactured for diaDexus by Denka Seiken (Tokyo).