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

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