QuidelOrtho Adds Ultra-Fast PCR Platform with LEX Acquisition

The transaction adds the LEX VELO System to QuidelOrtho’s portfolio. The platform received U.S. Food and Drug Administration (FDA) 510(k) clearance and CLIA waiver in February 2026. QuidelOrtho expects to initiate the U.S. commercial launch later this year, with global expansion to follow subject to local regulatory approvals.

The LEX VELO System is as an ultra‑fast PCR platform designed to deliver highly sensitive, multiplex RT-PCR testing for Influenza A, Influenza B, and COVID‑19 directly from a swab sample. Its proprietary, cartridge‑based design eliminates external liquid handling to emphasize speed, reliability, and ease of use. The system is intended to fit seamlessly into point‑of‑care workflows and support rapid clinical decision‑making in decentralized care settings.

Strategically, the acquisition marks a milestone in QuidelOrtho’s plan to accelerate growth in point‑of‑care molecular diagnostics by integrating innovative technology. The addition of LEX VELO complements the company’s positions in immunoassay, clinical chemistry, and transfusion medicine, and is intended to reinforce delivery of integrated diagnostic solutions across the continuum of care.

"The FDA clearance of the LEX VELO System and the completion of our acquisition of LEX mark a pivotal moment for QuidelOrtho and for our customers," said Brian J. Blaser, President and Chief Executive Officer of QuidelOrtho. "This ultra-fast PCR platform is designed to deliver lab-quality results in minutes and fits seamlessly into point-of-care workflows. It empowers providers to act faster, make better-informed decisions and ultimately improve patient outcomes. It also reflects our long-term commitment to bringing advanced diagnostics closer to the patient."

“LEX achieved an extraordinary milestone with FDA clearance and CLIA waiver of the LEX VELO System. We are proud to join QuidelOrtho and to bring this technology to customers worldwide. We believe we can redefine what is possible in point-of-care molecular diagnostics,” said Ed Farrell, Chief Executive Officer of LEX.