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Rapid UTI test that returns antibiotic susceptibility in hours gets FDA breakthrough designation
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Fusion42 · 21 September 2026 · Fusion42 review
Pattern Bioscience's Urine ID/AST Panel received FDA Breakthrough Device Designation for a rapid UTI test that identifies pathogens and antibiotic susceptibility directly from urine within hours, potentially reducing traditional multi-day culture workflows and improving clinical decision-making and antimicrobial stewardship.
This Wire brief sits within Fusion42's coverage of Medtech, and 3 sources have reported it.
◆ ◆ The Wire takeaway
Your diagnostic startup now faces faster paths for rapid infection testing approvals in the US, shifting urgent clinical needs towards phenotypic antibiotic susceptibility tests that compress lab workflows. Regulators are opening a door that favours devices speeding treatment decisions in sepsis-prone infections like UTIs.
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3 sources · 21 Sep 2026
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