Lex Diagnostics secured 510(k) clearance and a CLIA waiver for its Velo point‑of‑care molecular diagnostic system and a multiplex respiratory cartridge for influenza A/B and SARS‑CoV‑2. The system delivers lab‑quality PCR results in six to ten minutes, according to company statements and media coverage. QuidelOrtho’s prior investment in Lex and an acquisition option tied the approval to commercial expectations; analysts noted that the Velo system’s speed and CLIA waiver broaden its use case across urgent care, pharmacies, and decentralized clinics. Lex said U.S. commercial activities will begin this year and highlighted compatibility with primary‑care workflows. The clearance underscores ongoing pressure to develop rapid, decentralized molecular diagnostics that reduce turnaround times and improve clinical decision‑making in outpatient settings.