QuidelOrtho told investors that its planned acquisition of UK molecular system developer Lex Diagnostics depends on imminent FDA clearance of Lex’s point‑of‑care PCR Velo system and the agency’s CLIA‑waiver decision. Company executives described FDA review as slower than hoped while multiple device attributes — hardware, software, cybersecurity and usability — are under evaluation. QuidelOrtho announced it would discontinue its Savanna POC molecular system and pivot to acquiring Lex once regulators clear Lex’s swab‑to‑result PCR platform. Management said the Velo system’s higher‑margin molecular testing could improve gross margins after an initially dilutive rollout and that QuidelOrtho expects to launch multiple platforms in 2026 via organic R&D and partnerships. Investors will watch the timing of the FDA decision closely because clearance triggers the acquisition and materially affects QuidelOrtho’s near‑term product roadmap.