RSV
BioMérieux Respiratory/Sore Throat Mini Panel Gets FDA Special 510(k) Clearance, CLIA Waiver
The firm said that it expects its SpotFire Respiratory/Sore Throat (R/ST) Panel Mini test to be available in the US in the third quarter of 2024.
Roche Molecular Respiratory Virus Panel Receives FDA Emergency Use Authorization
The PCR-based test detects SARS-CoV-2, influenza A/B, and respiratory syncytial virus from a nasal swab sample.
FDA Seeks More Data in Cue Health De Novo Request for RSV Molecular Test
The FDA determined that Cue's test does not meet the criteria for a Class I or Class II medical device for over-the-counter use and wants more data from the company.
The company's full-year 2023 revenues fell 85 percent to $70.9 million but beat the Wall Street consensus estimate.
Cue Health Anticipates Multiple Upcoming Test Launches as Q3 Revenues Fall 75 Percent
The company's product revenues fell 78 percent to $14.8 million, while grant and other revenues fell 7 percent to $2.7 million.
May 24, 2023
Domus Diagnostics Wins $2.4M NIH RADx Tech Contract
Feb 6, 2023