Home / Health / FDA Clears VELO: Fast Molecular Diagnostics for Clinics
FDA Clears VELO: Fast Molecular Diagnostics for Clinics
17 Feb
Summary
- LEX Diagnostics' VELO system received FDA 510(k) clearance and CLIA waiver.
- The PCR platform provides respiratory pathogen results in under ten minutes.
- Commercial activities in the US are anticipated to commence in 2026.
LEX Diagnostics has successfully obtained US Food and Drug Administration (FDA) 510(k) clearance and a Clinical Laboratory Improvement Amendments (CLIA) waiver for its innovative VELO system. This platform represents a major advancement in point-of-care molecular diagnostics, designed to deliver sensitive polymerase chain reaction (PCR) results from a simple swab sample in under ten minutes.
The VELO system is capable of multiplex testing for influenza A and B, alongside Covid-19, providing accurate real-time PCR results within six to ten minutes. Its versatile design allows for seamless integration into various clinical workflows, including urgent care clinics, primary care settings, physician offices, pharmacies, and decentralized acute care locations.
Clinical studies supporting the VELO system and its influenza/Covid assay were successfully concluded in the United States during the 2024/2025 respiratory season. LEX Diagnostics anticipates initiating its US commercial activities in 2026. The company's CEO, Ed Farrell, expressed confidence that the VELO system will redefine point-of-care testing, offering lab-quality results in minutes to healthcare providers.
This groundbreaking clearance is the culmination of years of dedicated innovation aimed at making molecular diagnostics faster, simpler, and more accessible. The VELO system's cartridge-based design eliminates the need for external liquid handling, enhancing its usability and reliability across diverse healthcare environments.
