Austin, Texas — Pattern Bioscience announced that the U.S. Food and Drug Administration has granted Breakthrough Device Designation to its Urine ID/AST Panel, a rapid diagnostic test designed to identify urinary tract infection pathogens and determine antibiotic susceptibility directly from urine specimens.
The Urine ID/AST Panel is the company’s second assay to receive the designation, following its Pneumonia ID/AST Panel. Both use Pattern’s single-cell microbiology platform.
The FDA’s Breakthrough Devices Program is intended to speed the development and review of medical devices that may provide more effective diagnosis or treatment for life-threatening or irreversibly debilitating conditions. The designation does not constitute FDA clearance or approval, and the Urine ID/AST Panel is not yet available for sale.
“Pneumonia and urinary tract infections (UTIs) are the two most common infection types that progress to sepsis, and with this designation Pattern now has breakthrough-designated programs for both,” said Carey-Ann Burnham, Ph.D., Chief Executive Officer of Pattern Bioscience. “UTI sits at the intersection of three 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 three.”
Urinary tract infections are among the most common bacterial infections and a frequent reason for antibiotic use. Treatment often begins before conventional culture results are available, which can take several days.
Pattern’s Urine ID/AST Panel is designed to detect, identify and quantify pathogens while providing same-day phenotypic antimicrobial susceptibility results directly from urine samples. The company said the approach could help laboratories determine both the organism causing an infection and which antibiotics are likely to be effective.
“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. A direct-from-specimen result would compress two to three days into a single shift. This has the potential to impact what the lab can offer the clinicians and patients that it serves,” said Sarah E. Turbett, M.D., Director for Antimicrobial Stewardship and a Clinical Microbiologist at Mass General Brigham in Boston.
The assay uses the same single-cell microbiology platform as Pattern’s Pneumonia ID/AST Panel. Pattern Bioscience said its products are for investigational use only and have not been cleared by the FDA.
