The single-cell microbiology assay is designed to provide same-day pathogen identification and antimicrobial susceptibility results directly from uncultured urine specimens.
The US Food and Drug Administration (FDA) has granted Breakthrough Device Designation for Pattern Bioscience’s Urine ID/AST Panel. The assay is the company’s second diagnostic test to receive the designation, following its Pneumonia ID/AST Panel, and operates on Pattern’s single-cell microbiology platform.
The FDA Breakthrough Devices Program is intended to speed the development and review of medical technologies designed to provide more effective treatment or diagnosis for life-threatening or irreversibly debilitating conditions. The designation does not constitute FDA clearance or approval, and the Urine ID/AST Panel is currently designated for investigational use only and is not yet available for commercial sale, the company notes in a press release.
Addressing Diagnostic Delays and High-Volume Laboratory Workloads
According to Pattern Bioscience, urinary tract infections (UTIs) are among the most common bacterial infections and represent a primary reason antibiotics are prescribed, affecting millions of patients across the US each year. Clinical treatment frequently begins empirically because standard culture methods require several days to return definitive results.
The company reports that a substantial proportion of urine cultures ultimately return negative, meaning many patients receive empiric antibiotics that could have been avoided or discontinued sooner. Conversely, when cultures are positive, the prolonged turnaround time associated with conventional testing can delay optimal, targeted antimicrobial therapy.
“Pneumonia and UTIs are the two most common infection types that progress to sepsis, and with this designation Pattern now has breakthrough-designated programs for both,” says Carey-Ann Burnham, PhD, CEO of Pattern Bioscience, in a release. “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.”
Single-Cell Platform Compresses Turnaround to a Single Shift
Pattern Bioscience states that its single-cell microbiology platform is designed to provide direct-from-specimen answers in hours rather than days. The Urine ID/AST Panel detects, identifies, quantifies, and delivers same-day phenotypic antimicrobial susceptibility testing directly from uncultured urine samples, providing the diagnostic data clinicians typically obtain from conventional culture.
“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,” says Sarah E Turbett, MD, the director for antimicrobial stewardship and a clinical microbiologist at Mass General Brigham in Boston, MA, in a release.
The company indicates that the development of the urine panel supports its ongoing strategy to establish a broader portfolio of rapid, direct-from-specimen infectious disease assays on a single instrument platform.
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