Pattern Bioscience Receives FDA Breakthrough Device Designation for Urine ID/AST Panel

Pattern Bioscience, an Austin, Texas-based innovator in rapid diagnostic technologies for bacterial infections, has announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Device Designation for its Urine ID/AST Panel. The panel is the company’s second assay to receive the designation, following the Pneumonia ID/AST Panel, reflecting Pattern’s continued focus on expanding a menu of rapid, direct-from-specimen assays.

The Urine ID/AST Panel is designed to deliver the answers laboratories and clinicians rely on from culture to support infection diagnosis: what organism is causing it and which antibiotics will treat it. It does this by detecting, identifying, quantifying, and providing same-day phenotypic antimicrobial susceptibility for pathogens directly from urine specimens. The assay uses the same single-cell microbiology platform as Pattern’s Pneumonia ID/AST Panel, the first and only direct-from-specimen platform designed to provide these results in hours rather than the days culture requires. Pattern Bioscience’s products are for Investigational Use Only and have not been cleared by the FDA.

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