Lex Diagnostics began commercial ramp‑up for its Velo point‑of‑care molecular platform after securing FDA 510(k) clearance and a CLIA waiver for a flu/COVID assay. The cartridge‑based system performs sample‑to‑answer qPCR in about 10 minutes, positioning Velo as the fastest instrument in the clinical POC PCR category. CEO Ed Farrell emphasized scalable cartridge manufacturing and a low‑cost design aimed at clinics and decentralized settings; the system detects up to four targets directly from swabs. Lex has produced >100,000 cartridges and is focused on supply chain scale‑up and clinic adoption during upcoming respiratory seasons. Hospitals and outpatient clinics will evaluate turnaround, cost per test, and integration into existing workflows as determinative factors for adoption.
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