The assay uses machine learning to detect pathogens and resistance markers directly from urine samples with high sensitivity and specificity.
Biotia announced the publication of a clinical validation study in the American Society for Microbiology journal, Microbiology Spectrum. The study validates a next-generation sequencing (NGS) and machine learning–based approach for detecting urogenital pathogens and profiling antimicrobial resistance directly from clinical urine specimens.
Urinary tract infections (UTIs) are often difficult to diagnose using standard culture-based methods, particularly in recurrent or complicated cases. Biotia’s assay is designed to address these limitations by enabling “comprehensive,” culture-independent detection of bacteria and fungi, including fastidious organisms that are frequently missed by traditional diagnostics.
Clinical Validation and Performance
The study evaluated 1,470 clinical specimens across more than 1,600 reactions, achieving 97.2% sensitivity and 99.6% specificity. The company’s proprietary machine learning classifier, BIOTIA-DX, supported the results by reducing false positives through the elimination of contamination and commensal organisms.
Antimicrobial resistance gene profiling provided additional insights to help guide targeted therapy, while built-in quality controls were used to ensure consistent results.
“By combining clinical metagenomic sequencing with machine learning, we can detect a broader range of pathogens with high confidence and support more precise, data-driven care,” says Mara Couto-Rodriguez, chief scientific officer of Biotia, in a release. “These findings highlight the potential of NGS-based diagnostics to advance UTI care, reduce diagnostic uncertainty, and support antimicrobial stewardship.”
Advancing UTI Diagnostics
The BIOTIA-ID Urine Test is approved by New York State as a laboratory-developed test. The validation study indicates the test delivers the accuracy needed for clinicians to make informed treatment decisions for patients with recurrent or complicated UTIs, which are frequently misdiagnosed with conventional methods.
“The publication underscores the growing role of clinical metagenomic sequencing in complex infectious disease cases. Biotia’s platform enables clinicians to move beyond the constraints of culture-based testing toward a more comprehensive understanding of infection,” says Dorottya Nagy-Szakal, MD, PhD, chief medical officer of Biotia, in a release.
The BIOTIA-ID Urine Test is currently available for clinicians and patients.
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