LEX Diagnostics has received U.S. Food and Drug Administration (FDA) 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 10 minutes.¹

The FDA clearance 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, according to executives.

“This 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,” LEX Diagnostics CEO Ed Farrell said. “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 LEX system supports multiplex testing for key respiratory pathogens, including Influenza A, Influenza B, and COVID-19. It is precision-engineered to deliver PCR results in six to 10 minutes, easily integrating into point-of-care 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 completed clinical studies in the United States with the VELO system and the Influenza/COVID assay during the 2024/2025 respiratory season.

LEX Diagnostics is a privately held molecular diagnostics company developing products that enhance patient care by delivering clinical insights within minutes and when they are most valuable. Its ultra-fast thermal cycling technology delivers sensitive PCR results directly from a swab sample in a user-friendly system. The LEX Diagnostics system fits seamlessly into primary care workflows, bringing the sensitivity of PCR to urgent care centers, physicians’ office labs, and pharmacies at a much lower cost per test than competing molecular offerings.

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¹ This LEX Diagnostics product is cleared by the U.S. Food and Drug Administration and has not been approved for sale by any other regulatory authority.