LEX Diagnostics has achieved a significant milestone with the recent clearance from the US Food and Drug Administration (FDA) for its VELO system. This approval, which includes 510(k) clearance and CLIA waived status, positions VELO as a cutting-edge point-of-care molecular diagnostics platform.
Rapid Testing Breakthrough
The VELO system is engineered to deliver rapid, highly sensitive PCR results for crucial respiratory pathogens directly from a swab sample in less than ten minutes. This rapid turnaround is a game-changer for healthcare providers, especially in settings requiring immediate diagnostic information.
Founded in 2020 at Melbourn Science Park as a spin-out from TTP Group, LEX Diagnostics has been on a mission to revolutionize molecular diagnostics. The FDA application for the VELO system was submitted in June 2025, highlighting the company’s commitment to advancing healthcare technology.
Multiplex Testing Capabilities
One of the standout features of VELO is its ability to perform multiplex testing for various respiratory pathogens, including Influenza A, Influenza B, and Covid-19. This capability allows providers to obtain comprehensive diagnostic information from a single sample quickly.
The system’s precision engineering ensures PCR results are available in just six to ten minutes. Its design facilitates seamless integration into point-of-care workflows across various environments, such as primary care facilities, urgent care clinics, pharmacies, and decentralized acute care settings.
User-Friendly Design
The innovative cartridge-based design of VELO eliminates the need for external liquid handling, which enhances both usability and reliability. This simplification encourages more widespread adoption of molecular diagnostics in clinical settings, where speed and accuracy are paramount.
Ed Farrell, CEO of LEX Diagnostics, emphasized the significance of this achievement, stating that it reflects years of innovation and dedication. He believes that the VELO system will transform point-of-care testing by providing healthcare providers with lab-quality results within minutes.
Anticipated Commercial Launch
Commercial activities for VELO are expected to commence in 2026, which aligns with the company’s strategic plans. The FDA approval serves as a critical factor in the acquisition of LEX Diagnostics by QuidelOrtho, a prominent US manufacturer of diagnostic healthcare products.
QuidelOrtho, based in San Diego, aims to integrate LEX’s advanced molecular diagnostics capabilities with its established immunoassay platforms. The acquisition is valued at approximately $100 million, with the agreement contingent on the FDA’s approval of VELO.
Strengthening Market Position
“The intended acquisition of LEX Diagnostics will enhance our presence in point-of-care molecular diagnostics, a rapidly growing segment within the diagnostics industry,” stated Brian J Blaser, president and CEO of QuidelOrtho. This strategic move is expected to bolster QuidelOrtho’s product offerings and market reach.
In its recent financial report, QuidelOrtho announced a full-year revenue of $2.73 billion for 2025, experiencing a slight decline from the previous year. Blaser noted that the company has shifted from the volatility associated with Covid-19 to a more stable and diversified diagnostics business model.
Future Prospects
The outlook for QuidelOrtho, bolstered by the integration of LEX Diagnostics, appears promising. The anticipated contributions from LEX are expected to positively impact the company’s earnings in 2026, aligning with its goal of generating stronger free cash flow.
QuidelOrtho’s focus on cost-saving initiatives has already led to improved margins, positioning the company favorably for future growth. As the diagnostics landscape continues to evolve, the incorporation of VELO could play a pivotal role in shaping the future of point-of-care testing.
Key Takeaways
- LEX Diagnostics has received FDA clearance for its VELO system, enhancing point-of-care molecular diagnostics.
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VELO can deliver PCR results for respiratory pathogens in under ten minutes, promoting rapid decision-making in clinical settings.
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The system supports multiplex testing, allowing healthcare providers to obtain comprehensive results from a single swab sample.
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QuidelOrtho plans to integrate VELO’s capabilities into its existing product lines following the acquisition of LEX Diagnostics.
In conclusion, the FDA’s approval of the VELO system marks a transformative step for LEX Diagnostics and the broader diagnostics industry. With its innovative design and rapid testing capabilities, VELO is set to redefine how healthcare providers approach molecular diagnostics. As commercial activities ramp up, the potential for significant advancements in patient care and diagnostic efficiency is on the horizon.
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