Pattern Bioscience Wins FDA Breakthrough Device Designation for Urine ID/AST Panel
核心洞察
The FDA granted Breakthrough Device Designation to Pattern Bioscience (搜索)'s Urine ID/AST Panel (搜索), the company's second assay to receive the designation after its Pneumonia ID/AST Panel (搜索).
The panel detects, identifies, quantifies and provides same-day phenotypic antimicrobial susceptibility results directly from urine specimens on Pattern's single-cell microbiology platform.
Pattern CEO Carey-Ann Burnham said pneumonia (搜索) and UTIs are the two most common infection types that progress to sepsis (搜索), and the company now holds breakthrough-designated programs for both.
Pattern Bioscience (搜索) announced that the U.S. Food and Drug Administration has granted Breakthrough Device Designation for its Urine ID/AST Panel (搜索), a rapid diagnostic assay for urinary tract infections built on the company's single-cell microbiology platform. The Urine ID/AST Panel is the Austin, Texas-based company's second assay to receive the designation, following its Pneumonia ID/AST Panel (搜索).
The FDA's Breakthrough Devices Program is intended to accelerate development and review of medical devices that offer more effective diagnosis or treatment of life-threatening or irreversibly debilitating conditions, giving patients and clinicians faster access to technologies that address unmet needs. The designation does not constitute FDA clearance or approval, and the Urine ID/AST Panel (搜索) is not yet available for sale.
Two Sepsis-Linked Indications Now Covered
The designation reflects Pattern's strategy of building a menu of high-value diagnostic panels on a single platform. "Pneumonia (搜索) and urinary tract infections (UTIs) are the two most common infection types that progress to sepsis (搜索), and with this designation Pattern now has breakthrough-designated programs for both," said Carey-Ann Burnham, PhD, Chief Executive Officer of Pattern Bioscience (搜索). "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."
Compressing Culture Turnaround Into a Single Shift
UTIs are among the most common bacterial infections and a common reason antibiotics are prescribed, affecting millions of patients in the US each year. Treatment often begins empirically while culture takes days to return results. A substantial proportion of urine cultures are negative, yet many patients have already been started on antibiotics that could have been avoided or discontinued sooner. When cultures are positive, the turnaround time of conventional culture can result in delays to optimal antimicrobial therapy.
"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, MD, the Director for Antimicrobial Stewardship and a clinical microbiologist at Mass General Brigham in Boston, MA.
Assay Design and Platform
Pattern's Urine ID/AST Panel (搜索) is designed to deliver the answers laboratories and clinicians rely on from culture to support the diagnosis of infection: 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 (搜索), which the company describes as the first and only direct-from-specimen platform designed to provide these results in hours rather than the days culture requires. Pattern Bioscience (搜索)'s products are for Investigational Use Only, and the products have not been cleared by the FDA.
Regulatory Status
Pattern Bioscience (搜索) states that Breakthrough Device Designation does not guarantee that the FDA will clear or approve the device, or that any clearance will be obtained within a particular timeframe. The company's stated aim is to improve global health by reducing the burden of antibiotic resistance (搜索) through faster diagnosis of bacterial infections. Pattern Bioscience is privately held and based in Austin, Texas.