influenza
On the heels of CLIA waiver, the Austin, Texas-based firm aims to submit additional respiratory tests for regulatory clearance.
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.
Demand remains low, but lab stakeholders said the industry is significantly better prepared to meet a spike in H5N1 testing needs than it was during the COVID-19 pandemic.
Cubit Diagnostics Gets $2.6M in NIH RADx Funding for COVID/Flu Test on Multimodal Platform
The funding will support assay development on the firm's combined immunoassay/molecular diagnostic system.
Oct 1, 2024
Jul 1, 2024