New form of diaDexus' PLAC Test
This article was originally published in Clinica
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.
You may also be interested in...
Grail announced it will enroll about 6,200 people in an interventional, multi-center study evaluating its multi-cancer early-detection blood test. This is the first time health care providers will use this test to help guide patient care.
As of 5 February, the Scientific Committee on Consumer Safety is evaluating use of titanium dioxide – now officially classified as a Category 2 carcinogen in the EU – in cosmetic products that can expose consumers by way of inhalation. Without a favorable SCCS opinion, the ingredient’s use in those contexts will be banned under Article 15 of the Cosmetics Regulation.
Nanobiotix’s CEO outlines to Scrip how the biotech plans to develop and expand its lead asset into multiple cancer indications, and create a blockbuster.