RT-PCR
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.
BD Gains FDA Clearance for Combination COVID-19, Flu, RSV Molecular Test
The RT-PCR-based BD Respiratory Viral Panel for BD Max received a CE mark in 2022 and FDA Emergency Use Authorization earlier this year.
Diatech, Janssen Partner to Develop Molecular Diagnostics for Bladder Cancer
The bladder cancer test in development will profile genetic alterations in bladder cancer in three hours using real-time PCR.
Hologic Nabs FDA 510(k) Clearance for Respiratory Assay
The multiplex real-time RT-PCR test for SARS-CoV-2, influenza A and B, and RSV is designed for use on the firm's high-throughput Panther Fusion instrument.
SD Biosensor Eyes Global Expansion as Evaluations Find Rapid MDx System on Par With Competition
Premium
The sample-to-answer system can multiplex up to 12 targets and can run both isothermal assays and RT-PCR with results in 30 minutes or 60 minutes, respectively.