coronavirus
Breaking news on coronavirus testing, with real-time reporting on assays to detect the SARS-CoV2 coronavirus, which causes COVID-19.
Check out our Coronavirus Test Tracker for the latest information on the regulatory status of these tests in the US, European, and Asian markets.
Visby Medical Gains FDA 510(k) Clearance, CLIA Waiver for POC Respiratory Panel
The Visby Medical Respiratory Health Test is a disposable handheld RT-PCR-based assay for the detection and differentiation of SARS-CoV-2 and flu A/B.
The pharmaceutical firm said the decision was related to the cost associated with the molecular tests.
BioMérieux Nabs Health Canada Approval for Respiratory, Sore Throat Panel
The PCR test detects and identifies nucleic acids from up to 15 of the most common bacteria, viruses, and viral subtypes responsible for respiratory infections or sore throat.
Hologic Gains FDA 510(k) Clearance for SARS-CoV-2 MDx Test
The company gained Food and Drug Administration Emergency Use Authorization in 2020 for the test, which is designed for use on the company's Panther instruments.
Roche, Abbott, Inflammatix, Paige, Others Gain 510(k) Clearances in January
The US Food and Drug Administration in January granted 510(k) marketing clearances for a 30-minute sepsis test, digital pathology software, and various infectious disease tests