FDA clears Lex’s Velo POC PCR and grants CLIA waiver – multiplex respiratory test cleared

Lex Diagnostics received 510(k) clearance and a CLIA waiver for its Velo point‑of‑care molecular system and an influenza A/B plus COVID‑19 assay. The cartridge‑based system delivers multiplex ultra‑fast PCR results from swabs in roughly six to 10 minutes, positioning it for primary care, urgent care, pharmacies, and decentralized acute settings. Lex expects U.S. commercial activities to begin this year; the company noted QuidelOrtho’s prior investment and potential acquisition terms tied to FDA clearance. Lex’s CEO framed the approval as a step to deliver lab‑quality molecular results at the point of care and accelerate clinical decision making. The clearance adds to a wave of rapid molecular diagnostics approvals and could reshape respiratory testing workflows if rollout scales as projected.