Lex Diagnostics received 510(k) clearance and a CLIA waiver from the FDA for its Velo point‑of‑care molecular system and a multiplex assay detecting influenza A, influenza B, and SARS‑CoV‑2. The cartridge‑based platform delivers multiplex ultra‑fast PCR results in roughly six to ten minutes from swab samples. CEO statements and company releases positioned Velo as a rapid, clinic‑compatible molecular option for urgent care, pharmacies, and decentralized settings. QuidelOrtho has invested in Lex and has an option to acquire the company contingent on commercial milestones; Lex expects U.S. commercialization later this year. The clearance adds a fast molecular competitor to the point‑of‑care diagnostics market and could alter workflows by enabling rapid, lab‑quality decisions at the bedside.