June 6, 2025 – LEX Diagnostics, a leading innovator in molecular diagnostics, has submitted dual applications to the U.S. Food and Drug Administration (FDA) seeking 510(k) clearance and CLIA waived status for its VELO system, an ultra-fast point-of-care molecular diagnostics platform designed to deliver highly sensitive PCR results for key respiratory pathogens directly from a swab sample in under ten minutes. [1]
The FDA submission represents a pivotal step in LEX Diagnostics’ strategy and underscores the company’s commitment to advancing point-of-care testing with accurate, timely, and clinically actionable results.
“This milestone reflects the strength of our R&D and clinical validation programs, as well as our broader mission to make molecular diagnostics faster, simpler, and more accessible,” said Ed Farrell, Chief Executive Officer of LEX Diagnostics. “We believe the LEX VELO system will redefine point-of-care testing by equipping healthcare providers with lab-quality results in minutes, enabling faster clinical decisions and improved patient outcomes without compromising quality while improving workflow—an achievement that will set us apart in the marketplace.”
The LEX system supports multiplex testing for key respiratory pathogens, including Influenza A, Influenza B, and COVID-19, and is engineered to deliver PCR results in six to ten minutes, easily integrating into clinical workflows across primary care settings, urgent care clinics, pharmacies, physician office laboratories and decentralized acute settings. Its proprietary cartridge-based design eliminates the need for external liquid handling, promoting ease of use and reliability. LEX recently completed clinical studies in the United States with the VELO system and the Influenza/Covid assay during the 2024/2025 respiratory season.
LEX Diagnostics anticipates U.S. market clearance in late 2025 or early 2026, in alignment with expected FDA review timelines.
[1] This LEX Diagnostics product is currently under development and has not been cleared or approved by the U.S. Food and Drug Administration or any other regulatory authority. It is not available for sale or distribution in the U.S., the U.K. or any other jurisdiction. All product descriptions, data, or discussions are preliminary, subject to change, and do not represent final or FDA-approved claims, indications, or labeling.