LEX Diagnostics has secured the US Food and Drug Administration (FDA) 510(k) clearance and Clinical Laboratory Improvement Amendments (CLIA) waiver for its VELO system.

The platform is a polymerase chain reaction (PCR) point-of-care diagnostics platform for respiratory pathogens that delivers sensitive PCR results from a swab sample in less than ten minutes.

The clearance marks a significant milestone in LEX Diagnostics’ business strategy as it aims to improve access to point-of-care molecular testing.