LEX Diagnostics has secured US Food and Drug Administration 510(k) clearance and CLIA waived status for its VELO molecular diagnostics system, an ultra-rapid point-of-care platform capable of delivering highly sensitive PCR results for major respiratory pathogens directly from a swab sample in under ten minutes.

The regulatory milestone marks a significant step in the company’s commercialization strategy and highlights its focus on advancing point-of-care diagnostics with accurate, timely, and clinically actionable results.

Company leadership said the clearance reflects years of innovation aimed at simplifying molecular testing while maintaining laboratory-level performance. The VELO system is designed to help healthcare providers make faster clinical decisions, improving workflow efficiency and patient care without sacrificing diagnostic quality. Commercial rollout in the United States is expected to begin in 2026.

The platform supports multiplex testing for respiratory pathogens including influenza A, influenza B, and Covid-19. Engineered to generate PCR results within six to ten minutes, the cartridge-based system integrates easily into decentralized clinical environments such as primary care clinics, urgent care centers, pharmacies, and physician office laboratories. Its closed design removes the need for external liquid handling, enhancing usability and reliability. Clinical studies evaluating the VELO system and its respiratory assay were completed in the US during the 2024–2025 respiratory season.

LEX Diagnostics develops high-speed molecular diagnostic solutions intended to deliver critical clinical insights at the point of care, enabling faster and more informed treatment decisions.