QuidelOrtho Corp, one of the world’s leading manufacturers of innovative diagnostic products, proudly declared the completion of their purchase of LEX Diagnostics (“LEX”) in a deal worth approximately $100 million. This comes after FDA 510(k) clearance and CLIA waiver issued by the United States Food and Drug Administration for the LEX VELO System was granted in February 2026.
Re-defining Rapid Point of Care Molecular Testing
The LEX VELO System is a technological breakthrough for decentralized testing. The system, which is capable of delivering high sensitivity multiplex RT-PCR detection of Influenza A, Influenza B, and COVID-19 infection, provides lab quality results directly from a swab test sample in approximately six to ten minutes using a unique cartridge based technology that does not require external liquid handling.
This purchase marks an important component in QuidelOrtho‘s strategy towards rapid growth in the molecular diagnostics space, especially with regards to the point of care market segment.
Also Read: Toshiba Launches SmartMCD™ Motor Control IC with Advanced Sensorless Technology
“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.”
Expanding the Continuum of Care
By integrating LEX’s molecular capabilities into its existing portfolio-which already commands leadership positions in immunoassay, clinical chemistry, and transfusion medicine-QuidelOrtho is further cementing its ability to provide comprehensive diagnostic solutions across every clinical environment, from hospital laboratories to retail clinics.
“LEX achieved an extraordinary milestone with FDA clearance and CLIA waiver of the LEX VELO System,” said Ed Farrell, Chief Executive Officer of LEX. “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.”
Commercialization Strategy
The commercialization of the LEX VELO System in the United States is expected to begin in 2026. After the domestic commercialization, QuidelOrtho will move on to international expansion, pending local regulatory approval.
