FDA Grants Breakthrough Device Designation to Same-Day Urine ID/AST Test

The FDA has granted Breakthrough Device Designation to Pattern Bioscience’s Urine ID/AST Panel, a single-cell microbiology assay that provides same-day pathogen identification and antimicrobial susceptibility results directly from uncultured urine specimens. This designation aims to speed development and review to better diagnose UTIs, which are a major driver of antibiotic use and sepsis risk, by compressing traditional test turnaround from days to hours.

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