NEW YORK (GenomeWeb) — The US Food and Drug Administration has cleared for marketing Quidel's AmpliVue GAS Assay for detection of Group A Streptococcus from throat swabs in patients with symptoms of pharyngitis, the company announced today.
Packaging isothermal PCR reagents in blisters and using lateral flow detection, researchers at Boston University hope to develop a low-cost, disposable assay for Bordetella pertussis, the causative agent of whooping cough.
NEW YORK (GenomeWeb News) – Quidel said after the close of the market on Monday that the US Food and Drug Administration has cleared the company's AmpliVue Group B Strep Assay, the second assay to receive FDA clearance to run on the AmpliVue handheld molecular testing platform.
With its acquisition this week of privately held molecular diagnostic developer BioHelix, clinical diagnostics firm Quidel adds to its portfolio of technologies to enable its burgeoning molecular diagnostics business.
Consulting company McKinsey says diagnostics companies will have to combine genomic data analysis, electronic medical records, effective reimbursement strategies, and regulatory compliance in order to win.