In Brief This Week: PerkinElmer, Rheonix, Genetic Signatures, More
News items for the week of July 25, 2022.
Thermo Fisher Scientific, Diazyme Laboratories, Rheonix, Others Obtain FDA Clearances in December
Thermo Fisher got the nod for its Sensititre 18 to 24 hour minimum inhibitory concentration or breakpoint susceptibility system with cefiderocol.
FDA Emergency Use Authorization for Rheonix SARS-CoV-2 Assay Expanded to Include Saliva Samples
The expanded EUA allows for testing of saliva samples collected in a sterile tube in a hospital setting.
Rheonix Gets FDA Emergency Use Authorization for Coronavirus MDx Test
The endpoint RT-PCR test is processed on the company's Encompass CARD cartridge, which runs on Rheonix's Encompass MDx workstation.
Commercial Coronavirus Test Developers Tweak Timelines, EUA Plans in Light of Loosened FDA Guidance
Test makers are preparing to ramp up production of new SARS-CoV-2 assays and designated testing systems in anticipation of increased demand.