FDA clears Roche's automated D-Dimer test:
This article was originally published in Clinica
Roche Diagnostics has received US FDA 510(k) marketing clearance to use its D-Dimer assay, for excluding a diagnosis of deep vein thrombosis (DVT) and pulmonary embolism, on an automated clinical chemistry platform. The assay can be run on the firm's Roche/Hitachi and Cobas Integra chemistry analysers and can produce a result in just 10 minutes. DVT affects around 1 million people in the US each year.