Red Bear Angels portfolio company Biotia has published a pivotal clinical validation study in the American Society for Microbiology's Microbiology Spectrum journal. The study 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.
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, reduces false positives by eliminating contamination and commensal organisms. The BIOTIA-ID Urine Test has been approved by New York State as a laboratory-developed test and is already available for clinicians and patients.
"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. Urinary tract infections affect millions annually and are often difficult to diagnose using standard culture-based methods, making Biotia's innovation a significant advancement in diagnostic precision.
