LEX Diagnostics has secured the US Food and Drug Administration (FDA) 510(k) clearance and Clinical Laboratory Improvement Amendments (CLIA) waiver for its VELO system.
The platform is a polymerase chain reaction (PCR) point-of-care diagnostics platform for respiratory pathogens that delivers sensitive PCR results from a swab sample in less than ten minutes.
The clearance marks a significant milestone in LEX Diagnostics’ business strategy as it aims to improve access to point-of-care molecular testing.
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VELO enables multiplex testing for influenzas A and B, as well as Covid-19, providing real-time PCR results within six to ten minutes.
Designed for integration into various clinical workflows, it is intended for use in urgent care clinics, primary care settings, physician office laboratories, pharmacies, and decentralised acute locations.
The cartridge-based design removes the need for external liquid handling, enhancing usability and reliability across various healthcare settings.
Clinical studies using the VELO system and its influenza/Covidassay were completed in the US during the 2024/2025 respiratory season.
According to the company, the product currently holds clearance solely from the FDA and has not received approval from any other regulatory authorities.
LEX Diagnostics CEO Ed Farrell said: “This groundbreaking achievement is a result of several years of innovation, problem-solving, and dedication to our mission to make molecular diagnostics faster, simpler, and more accessible. We believe our VELO system will redefine point-of-care testing by equipping healthcare providers with lab-quality results in a few minutes.
“This improved point-of-care workflow will enable faster clinical decisions and improved patient outcomes without compromising quality — an achievement that will set us apart in the marketplace. We anticipate US commercial activities will begin in 2026.”
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