QuidelOrtho has completed its acquisition of LEX Diagnostics following FDA 510(k) clearance and CLIA waiver for the LEX VELO™ System, a rapid molecular platform designed for decentralized respiratory testing.
The LEX VELO System performs multiplex RT-PCR testing for influenza A, influenza B, and SARS-CoV-2 directly from swab samples, delivering results in approximately 6 to 10 minutes. The cartridge-based system eliminates external liquid handling steps, enabling a simplified sample-to-answer workflow intended for use in urgent care clinics, clinician office laboratories, pharmacies, and hospital settings.
The system is designed to provide “highly sensitive, multiplex RT-PCR testing… directly from a swab sample in approximately six to ten minutes,” according to the announcement, positioning it within the growing category of ultra-rapid molecular diagnostics intended for near-patient use.
A shift in respiratory testing
For clinical laboratories, the development reflects a broader shift in respiratory testing toward decentralized models. CLIA-waived molecular platforms such as LEX VELO may reduce routine respiratory testing volume in core labs, particularly in outpatient and urgent care settings where rapid turnaround is prioritized at the point of care.
At the same time, this shift may increase the importance of laboratory oversight, result integration, and quality assurance across distributed testing sites.
Strengthening point-of-care testing
QuidelOrtho said the acquisition strengthens its position in point-of-care molecular diagnostics and complements its existing immunoassay, clinical chemistry, and transfusion medicine portfolios. The company described the platform as part of its strategy to “bring advanced diagnostics closer to the patient.”
“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 CEO of QuidelOrtho. “This ultra-fast PCR platform is designed to deliver lab-quality results in minutes and fits seamlessly into point-of-care workflows.”
LEX Diagnostics CEO Ed Farrell added that the clearance represents a key milestone for the technology, stating, “LEX achieved an extraordinary milestone with FDA clearance and CLIA waiver of the LEX VELO System.”
Integrating rapid testing into existing algorithms
The company expects to begin US commercial launch of the system later this year, with global expansion planned pending regulatory approvals. As ultra-rapid molecular testing platforms expand, laboratories will likely continue to evaluate how these systems integrate into existing respiratory testing algorithms and how performance compares to centralized PCR methods during both seasonal and outbreak-driven demand.
Note: This news summary was generated by AI based on a published press release, followed by a review from human editors.
