Milestone marks the half-way point of enrollment in pivotal U.S. study designed to support 510(k) submission for the first culture-free, rapid phenotypic ID/AST panel for critically ill pneumonia patients
AUSTIN, Texas--(BUSINESS WIRE)--Pattern Bioscience, an innovator in rapid diagnostic technologies for bacterial infections, today announced that more than 1,000 samples have been enrolled in its ongoing multi-center U.S. clinical trial evaluating the Pattern Pneumonia ID/AST Panel and Pattern System. The study is designed to support a 510(k) regulatory submission for the company’s first commercial test, targeting critically ill patients with suspected pneumonia.
Pneumonia is a leading cause of sepsis, and carries the highest mortality rate among sepsis-related infections. Yet clinicians treating critically ill patients must often wait two to four days for conventional culture-based methods to return pathogen identification and antimicrobial susceptibility results. This delay contributes to higher mortality, prolonged ICU stays, and the spread of antimicrobial resistance. Pattern’s single-cell microbiology technology is designed to close this gap by analyzing bacterial cells directly from respiratory specimens, delivering pathogen identification and phenotypic antimicrobial susceptibility results in hours rather than days.
“Clinicians managing critically ill pneumonia patients need the ability to quickly optimize antibiotic therapy based on phenotypic susceptibility data—that capability doesn’t exist today,” said Eric Ransom, PhD, D(ABMM), Medical Director of Clinical Microbiology at University Hospitals Cleveland Health System and Assistant Professor of Pathology at Case Western Reserve University School of Medicine. “Clinical studies evaluating rapid, direct-from-specimen approaches to ID/AST are a critical step toward addressing that gap.”
The pivotal trial is expected to enroll approximately 2,000 total samples across 11 external clinical sites, including six enrollment & testing sites and five enrollment sites. The study includes prospective clinical specimens as well as contrived and challenge samples to ensure comprehensive performance evaluation across clinically relevant microorganisms and resistance profiles. The primary endpoint is concordance with reference methods for pathogen identification and antimicrobial susceptibility testing, with comparator testing conducted by an independent reference laboratory.
“This enrollment milestone reflects strong engagement from our clinical partners and disciplined execution by the Pattern team,” said Carey-Ann Burnham, PhD, Chief Executive Officer of Pattern Bioscience. “We have aligned with the FDA on our analytical and clinical validation strategy and protocols, and are focused on completing enrollment by mid-year and submitting our data package in the third quarter. Every day that a critically ill patient waits for susceptibility results can be a day of suboptimal therapy—our mission is to eliminate that wait.”
The Pneumonia ID/AST Panel has been granted Breakthrough Device Designation by the U.S. Food and Drug Administration and is supported by a contract valued at up to $40.9 million from the Biomedical Advanced Research and Development Authority (BARDA). In parallel with clinical enrollment, Pattern’s analytical studies, instrument verification, and software validation activities are progressing on schedule toward a planned third-quarter regulatory submission. Upon FDA clearance, the Pneumonia ID/AST Panel would become the first culture-free, rapid phenotypic susceptibility testing panel available for critically ill pneumonia patients in the United States.
Pattern’s platform is designed to support a broad menu of tests, including high-value ID/AST assays across respiratory, urinary tract, and bloodstream infections.
About Pattern Bioscience
Pattern Bioscience aims to save lives by transforming how bacterial infections are diagnosed and to improve global health by reducing the burden of antibiotic resistance. Its single-cell microbiology technology is designed to deliver clinically actionable results in hours, compared with the days required for traditional culture-based methods. Pattern Bioscience is a privately held company based in Austin, Texas. For more information, visit pattern.bio.
This project has been supported in part with federal funds from the Department of Health and Human Services; Administration for Strategic Preparedness and Response; Biomedical Advanced Research and Development Authority (BARDA), under contract number 75A50124C00042.
Research reported in this press release received support from CARB-X (Combating Antibiotic-Resistant Bacteria Biopharmaceutical Accelerator), a global non-profit partnership dedicated to supporting early-stage antibacterial research and develop to address the rising threat of drug-resistant bacteria.
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Media Contact
Kyle Fieleke
kyle@pattern.bio
