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Genomics and AI-Powered Urine Infectious Disease Test Addresses Critical Need for Complicated UTIs

By LabMedica International staff writers
Posted on 02 Jan 2025

Urinary tract infections (UTIs) are the most prevalent outpatient infection, affecting over 7 million patients annually, with women being disproportionately impacted. More...

UTIs can severely affect the quality of life and lead to significant health complications. Around 30% of sepsis cases stem from the urogenital tract, with immunocompromised patients being at a higher risk of developing urosepsis. Current diagnostic methods are slow and fail to detect many pathogens, including fastidious bacteria, anaerobes, and fungi. A new genomics-based urine assay using artificial intelligence (AI) now offers a faster, more accurate (97% sensitivity, 99% specificity), and comprehensive solution for identifying urogenital pathogens, including those often missed by traditional culture techniques.

The BIOTIA-ID urine NGS assay by Biotia (New York, NY, USA) combines AI and genomics, specifically shotgun metagenomic sequencing, to provide a comprehensive detection of pathogens, reducing false positives and overcoming the limitations of traditional methods such as culture, PCR, and targeted 16S amplicon next-generation sequencing (NGS), which frequently produce incomplete, unclear, or contradictory results. Powered by BIOTIA-DX software, this qualitative NGS-based in-vitro diagnostic test identifies clinically relevant urogenital pathogens from a database of over 7,000 clinically curated microbes. The test detects more than 30 pathogens known to cause UTIs, including fastidious bacteria, anaerobes, fungi, and polymicrobial infections.

BIOTIA-ID is designed specifically for high-risk patients with recurrent and complicated UTIs, serving as a reflex test for culture-negative specimens. This allows for a more targeted therapeutic approach based on the unique microbial profile of each patient’s sample. A recent clinical study showed the high performance of BIOTIA-ID, revealing that the assay identifies pathogens in 60% of urine samples where traditional culture methods fail. Alarmingly, 70% of these patients had previously been prescribed ineffective antimicrobials for the pathogens detected by BIOTIA-ID.

"Precision infectious disease diagnostics is not just about improving individual patient care; it is about transforming the healthcare landscape," said Dr. Niamh O'Hara, CEO and Co-Founder of Biotia. "By providing accurate, detailed, and timely information, we can move towards a future where treatment is truly personalized and public health is protected."

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