In Brief: Quidel
This article was originally published in The Gray Sheet
Executive Summary
Quidel: Files 510(k) application with FDA for its QuickVue "one-step" Helicobacter pylori test. Designed for use with whole blood at point-of-care locations, the new product represents an advance over earlier versions of the test and would provide greater ease-of-use than competing products, the firm claims. Quidel also announces 510(k) clearance of its QuickVue Chlamydia test. Described as "a lateral flow immunoassay containing highly specific antibodies reactive to the Chlamydia organism," the test combines "fewer steps and faster results" and the "highest sensitivity among rapid tests" to allow physicians "to perform immediate, in-office detection and treatment," the firm says. Quidel submitted the premarket notification in January...