LEX Diagnostics has received FDA clearance and CLIA waived status for its VELO system, an ultra-fast point-of-care molecular diagnostics platform that delivers lab-quality PCR results for key respiratory pathogens in under ten minutes.

 

“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,” said Ed Farrell, Chief Executive Officer of LEX Diagnostics. 

 

“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 U.S. commercial activities will begin in 2026.”

 

The VELO system supports multiplex testing for Influenza A, Influenza B, and COVID-19, producing PCR results in six to ten minutes. Its proprietary cartridge-based design eliminates external liquid handling, making it easy to integrate into primary care, urgent care, pharmacies, and decentralized acute settings. Clinical studies in the US during the 2024/2025 respiratory season validated the system and its Influenza/COVID assay.