FDA grants breakthrough device designation to urine ID/AST panel

The FDA has granted breakthrough device designation to an investigational urine ID/AST panel, a direct-from-specimen platform intended to support the diagnosis of urinary tract infection (UTI) by providing pathogen identification and antimicrobial susceptibility results within hours.¹

The assay is designed to deliver phenotypic antimicrobial susceptibility testing (AST) directly from urine specimens, potentially shortening the time to actionable microbiology results compared with conventional culture-based workflows.

Breakthrough device designation is granted to devices that provide for more effective diagnosis or treatment of life-threatening or irreversibly debilitating diseases or conditions. With this designation, the development pathway for the urine ID/AST panel can benefit from accelerated review.

“Urine is the highest-volume specimen type in nearly every clinical microbiology laboratory, and the conventional workflow hasn’t fundamentally changed in decades: culture overnight, identify, then set up susceptibility testing and wait again,” explained Sarah E. Turbett, MD, director for antimicrobial stewardship and a clinical microbiologist at Mass General Brigham in Boston, in a news release.¹ “A direct-from-specimen result would compress 2 to 3 days into a single shift. This has the potential to impact what the lab can offer the clinicians and patients that it serves.”

Investigational assay targets faster identification

Pattern Bioscience said the urine ID/AST panel is being developed to provide information typically obtained through urine culture, including the organism responsible for infection and its antimicrobial susceptibility profile. The company describes the assay as a rapid, direct-from-specimen test that detects, identifies, quantifies, and provides same-day phenotypic AST for pathogens in urine.

The company said the urine ID/AST panel uses the same single-cell microbiology platform as its pneumonia ID/AST panel. Pattern received Breakthrough Device Designation for the investigational pneumonia assay in December 2021.²

“Pneumonia and urinary tract infections (UTIs) are the 2 most common infection types that progress to sepsis, and with this designation Pattern now has breakthrough-designated programs for both,” said Carey-Ann Burnham, PhD, CEO of Pattern Bioscience, in the news release.¹ “UTI sits at the intersection of 3 problems: urine specimens create the highest-volume workload in the clinical microbiology laboratory, UTI is a common infection type progressing to sepsis, and UTIs are one of the biggest drivers of antibiotic use. A direct-from-specimen answer addresses all 3.”

REFERENCES

1. Pattern Bioscience receives FDA Breakthrough Device Designation for urine ID/AST panel. News release. Pattern Bioscience. September 21, 2026. Accessed September 21, 2026. https://pattern.bio/pattern-bioscience-receives-fda-breakthrough-device-designation-for-urine-id-ast-panel/

2. Pattern receives FDA “Breakthrough Device Designation” for pneumonia action panel. News release. Pattern Bioscience. December 8, 2021. Accessed September 21, 2026. https://pattern.bio/pattern-receives-fda-breakthrough-device-designation-for-pneumonia-action-panel/