Lex Diagnostics commenced commercialization of Velo, a point‑of‑care molecular diagnostic platform cleared by the FDA (510(k)) with a CLIA waiver for a flu/COVID assay. The Velo delivers cartridge‑based, sample‑to‑answer qPCR in roughly 10 minutes and is pitched as the fastest true POC system of its class. CEO remarks and company materials highlighted a compact cartridge design, ultra‑fast thermal cycles enabled by novel heater elements, and manufacturing scalability backed by over 100,000 produced cartridges. Lex said it will focus commercial efforts on outpatient clinics and other POC settings seeking rapid actionable viral testing within a patient visit. Regulatory clearance and the CLIA waiver underpin immediate commercial deployment; the company will track clinical adoption and reimbursement uptake as metrics of early success.
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