NEW YORK, April 23, 2026 /PRNewswire/ — Biotia, a company advancing infectious disease diagnostics for challenging infections, today announced the publication of a pivotal clinical validation study in the American Society for Microbiology Journal, Microbiology Spectrum. The study introduces and validates a novel next-generation sequencing (NGS) and machine learning–based approach for detecting urogenital pathogens and profiling antimicrobial resistance directly from clinical urine specimens with high accuracy.

Urinary tract infections (UTIs) affect millions annually and are often difficult to diagnose using standard culture-based methods, particularly in recurrent or complicated cases. Biotia’s assay addresses these limitations by enabling comprehensive, culture-independent detection of bacteria and fungi, including fastidious organisms that frequently are missed by traditional diagnostics. Clinical metagenomic-based diagnostics enable informed selection of antimicrobials to improve patient outcomes.

Robust 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. Biotia’s proprietary machine learning classifier, BIOTIA-DX, supported the high accuracy by reducing false positives through eliminating contamination and commensal organisms. Antimicrobial resistance gene profiling provided additional insights to help guide targeted therapy. Built-in quality controls ensured consistent and standardized results.

Advancing Care for UTI Patients

UTIs, especially recurrent and complicated cases, are frequently misdiagnosed or underdiagnosed with conventional methods. This clinical validation study demonstrates that the BIOTIA-ID Urine Test, approved by New York State as a laboratory-developed test (LDT), delivers the accuracy clinicians need to make more informed treatment decisions and improve patient outcomes.

“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,” said Mara Couto-Rodriguez, Chief Scientific Officer of Biotia. “These findings highlight the potential of NGS-based diagnostics to advance UTI care, reduce diagnostic uncertainty, and support antimicrobial stewardship.”

A Step Forward in Diagnostic Innovation

“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,” said Dorottya Nagy-Szakal, MD, PhD, Chief Medical Officer of Biotia.

The BIOTIA-ID Urine Test is already available for clinicians and patients. For more information, visit biotia.io.

About Biotia

Biotia is a health-tech company located in New York, NY, that leverages sequencing-based technology and proprietary AI-powered software to rapidly and accurately identify microorganisms and antimicrobial resistance. As a spinout of Cornell Tech, Biotia has a New York State CLIA/CLEP lab for infectious disease testing. To learn more about Biotia, visit www.biotia.io, or connect on Instagram, Facebook, and LinkedIn.

Media Contact:
Biotia: +1 (888) 685-2885, media@biotia.io

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SOURCE Biotia, Inc.