LEX Diagnostics Seeks 510(k) Clearance and CLIA Waiver Status for its VELO system to Deliver Highly Sensitive PCR Results

Shots:

• The US FDA has received 510(k) clearance & CLIA waiver application of VELO system for highly sensitive PCR results for respiratory pathogens
• LEX Diagnostics has completed US trials of the VELO system & Influenza/COVID assay during the 2024/2025 season & expects 510(k) clearance by late 2025 or early 2026, pending FDA review
• VELO system allows multiplex PCR testing for respiratory pathogens, incl. Influenza A/B & COVID-19 to provide results within 6 to 10min. with a cartridge-based design, eliminating the need of external liquid handling for easier integration into clinical workflows

Ref: GlobeNewswire | Image: LEX Diagnostics| Press Release

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