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

Shots:

• The US FDA has granted 510(k) clearance & CLIA waiver to 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 respiratory season, with US commercial activities anticipated in 2026
• 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 for external liquid handling for easier integration into clinical workflows

Ref: Globenewswire  | Image: LEX Diagnostics  | Press Release

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