Clearance for Quidel's redesigned Helicobacter pylori test:
This article was originally published in Clinica
Executive Summary
US rapid diagnostics manufacturer Quidel has received clearance from the US FDA to market an updated version of its point-of-care test for H pylori infection. According to Quidel, the redesigned test produces quicker results and is performed on a smaller blood sample compared with the company's existing test. QuickVue One-Step H Pylori was originally cleared by the FDA in February 1996. Over 80% of peptic ulcer disease cases are believed to be associated with H pylori infection.