Summary: Biotia’s BIOTIA-ID Urine NGS Assay uses AI and genomics to deliver rapid, highly accurate UTI diagnoses.
Takeaways:
- The BIOTIA-ID Urine NGS Assay, a genomics-based diagnostic tool, offers 97% sensitivity and 99% specificity, effectively detecting pathogens in UTIs often missed by traditional culture methods.
- CLEP approval certifies that Biotia’s assay meets rigorous standards, allowing patients in New York access to accurate, comprehensive testing that enhances treatment precision and reduces ineffective antibiotic use.
- By identifying pathogens in 60% of cases that standard culture misses, BIOTIA-ID addresses critical diagnostic gaps, particularly for patients with complex or recurrent UTIs, promoting faster, more effective care.
Biotia, a provider in genomic-based infectious disease diagnostics, announced New York State (NYS) Department of Health Clinical Laboratory Evaluation Program (CLEP) approval of its BIOTIA-ID Urine NGS Assay as a laboratory-developed test (LDT).
Genomic Urine Assay
BIOTIA-ID is a genomics-based urine assay leveraging artificial intelligence (AI) approved by New York. This approval reflected Biotia’s commitment to meeting the rigorous standards set by the NYS Department of Health, which includes a thorough review of the analytical and clinical validation of the assay in Biotia’s CLIA laboratory in Queens, New York.
Improved UTI Testing
Urinary tract infections (UTIs) are the most common outpatient infection, affecting upwards of 7 million patients annually, and disproportionately impacting women. UTIs affect quality of life and cause serious health problems, with urogenital infections causing 30% of sepsis cases. The BIOTIA-ID test offers a rapid, highly accurate (97% sensitivity, 99% specificity), and comprehensive solution for identifying urogenital pathogens, including those often missed by traditional culture methods. BIOTIA-ID utilizes AI and genomics (i.e. shotgun metagenomic sequencing) for comprehensive pathogen detection, reducing false positives, and surpassing the limitations of culture, PCR and targeted 16S amplicon NGS testing, which often yield incomplete, unclear, or contradictory results.
“Precision infectious disease diagnostics is not just about improving individual patient care; it is about transforming the healthcare landscape,” says Niamh O’Hara, PhD, 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.”
Further reading: Research Shows Urine Tests May Detect Early Diseases
More About the BIOTIA-ID Assay
A recent clinical study, presented at IDWeek 2024, demonstrated the high performance of BIOTIA-ID, reporting that the assay identifies pathogens in 60% of urine samples for whom traditional culture-based techniques fail. Alarmingly, 70% of these patients had been prescribed ineffective antimicrobials to the pathogens BIOTIA-ID identified.
“This approval will enable us to offer access to this vital technology, ensuring that patients and clinicians in New York, and soon across the United States, have access to the most accurate and comprehensive diagnostic information available, with the ultimate goal of supporting the responsible use of antimicrobials and improving patient outcomes,” says Dorottya Nagy-Szakal, MD, PhD, chief medical officer at Biotia.
Addressing a Critical Need for Complicated UTIs
The BIOTIA-ID test is particularly valuable for patients with complicated and recurrent UTIs, or for patients who are immunocompromised, who often face diagnostic challenges and delays in receiving appropriate treatment.
“Biotia’s innovative UTI diagnostic is a potential step-change in how we manage these often challenging infections, including for the millions of women who suffer frequent urinary tract infections and take cycle after cycle of antibiotics for relief,” says Christina Jenkins, MD, Biotia investor, physician, and former health system executive. “Biotia’s ability to rapidly and accurately identify a broad range of pathogens means patients receive the right medication, faster — improving their experience, health outcomes, and promoting good antimicrobial stewardship in this age of growing drug resistance.”
Biotia says it is actively working with leading medical institutions and laboratories to integrate its product into clinical workflows, and insurance providers to ensure that BIOTIA-ID is accessible to the widest patient population.