Biotia
BIOTIA-ID URINE

Backed by rigorous research

Read our work on the BIOTIA-ID Urine Test, including peer-reviewed publications, white papers, conference posters, and more.

ADDITIONAL READING

Science you can trust

High accuracy for a breadth of pathogens

Performance

The BIOTIA-ID Urine Test has been extensively validated on clinical samples. It was validated to reliably detect 44 key UTI-causing pathogens and 16 drug resistance markers.

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Sensitivity
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Specificity
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0Drug-resistance markers
The Diagnostic Gap

A negative urine culture does not mean there is nothing there

In a retrospective study of 200+ symptomatic UTI patient samples that were negative by standard urine culture, the BIOTIA-ID Urine Test identified a causative pathogen in a majority of samples.

0%
of culture-negative samples had a pathogen detected by our test
Pathogen detectedNone detected

Knowing the pathogen changes the prescription

The Treatment Gap

Among the patients with a pathogen detected by the BIOTIA-ID Urine Test, the empiric antibiotic chosen under standard care would not have worked in over two out of three cases.

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of empiric prescriptions could have been improved
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of prescriptions would have had no effect on the pathogen found
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could have been de-escalated to a narrower-spectrum drug
White papers

Technical overviews of the BIOTIA‑ID Urine Test

Learn more about how the BIOTIA-ID Urine Test is changing the field of urinary tract infection diagnostics.

White paper · For Patients · For Providers

Negative Cultures: Patient Education for Recurrent, Chronic, or Complicated Urinary Tract Infections

Many patients with recurrent, chronic, or complicated urinary tract infections experience frustration when their lab cultures come back negative despite ongoing symptoms. As many as 1 in 3 urine cultures return negative

White paper · For Providers · For Health Systems

Advanced Molecular Diagnostics: Addressing Complicated and Recurrent Urinary Tract Infections through Clinical Metagenomics

Urinary tract infections affect an estimated 404 million people globally each year, including 11 million in the United States. While most UTIs are uncomplicated, a significant subset progresses to complicated or recurren

ADDITIONAL READING

Publications and conference presentations

Biotia's research and development in the clinical metagenomics space has been published in top journals and shared at leading academic and industry conferences. Review our research here.

STUDY2026
Frontiers in Cellular and Infection Microbiology

Analytical validation of a metagenomic next-generation diagnostic platform for urinary tract infection in a Thai tertiary hospital setting: a BI-Biotia UTI cohort study

Analytical validation of the BIOTIA-DX mNGS platform across 368 urine samples in a Thai tertiary hospital. Demonstrated 98.7% sample-level sensitivity and 94.6% organism-level sensitivity vs. culture, detected 264 additional organisms in culture-negative samples (predominantly anaerobes and fastidious species), and achieved 81–94% genotype–phenotype concordance for AMR prediction across major antibiotic classes — supporting transportability to Southeast Asian populations with distinct microbial epidemiology.

Read publicationDOI: 10.3389/fcimb.2026.1751074
STUDY2026
Microbiology Spectrum (ASM)

BIOTIA-ID: clinical validation of a next-generation sequencing-based assay for pathogen and antimicrobial resistance detection in urine

Clinical validation of BIOTIA-ID across 1,470 urine specimens and >14,500 analytes, with 97.2% sensitivity and 99.6% specificity, plus AMR profiling on a 332-specimen subset. Demonstrates a comprehensive, end-to-end NGS diagnostic with notable advantages over culture.

Read publicationDOI: 10.1128/spectrum.02026-25
STUDY2024
Open Forum Infectious Diseases (Oxford Academic)

Comprehensive Next-Generation Sequencing-Based Assay for Antimicrobial Resistance Gene Marker Identification in Urine

Evaluation of the clinical-grade BIOTIA-ID Urine NGS Assay for comprehensive AMR gene detection across 168 culture-positive and 201 culture-negative urine specimens. NGS-identified AMR genes were confirmed by qPCR, demonstrating an evolution-proof alternative to PCR panels for rapid, broad AMR diagnosis in urinary tract infections.

Read publicationDOI: 10.1093/ofid/ofae631.2319
STUDY2024
Open Forum Infectious Diseases (Oxford Academic)

Potential Application of a Clinical-Grade Next Generation Sequencing Assay for Detection of Bacterial Vaginosis Associated Organisms in Urine

Assessment of the BIOTIA-ID Urine NGS Assay as a tool to diagnose bacterial vaginosis (BV) directly from urine. The team developed an NGS-based Nugent-style score from the compositional dynamics of lactobacilli and BV-associated organisms across 201 culture-negative urine specimens from symptomatic patients and 20 healthy donors — extending UTI workup to include vaginal dysbiosis.

Read publicationDOI: 10.1093/ofid/ofae631.2313
POSTER2023
ID Week 2023

Utilization of Clinical-Grade Metagenomics in Urinary Tract Infection Diagnostics: Improving High-Risk Patients’ Outcomes with a Genomic-Based Assay

POSTER2023
ASM 2023

Highly Accurate and Reliable Next-Generation Sequencing-Based Urine Assay Overperforms Conventional Diagnostics

STUDY2022
Open Forum Infectious Diseases (Oxford Academic)

Clinical-Grade Metagenomics in Urinary Tract Infections: Improving Performance of Next-Generation Sequencing Assays Using Internal Controls and Machine Learning

Development of an end-to-end clinical-grade metagenomics pipeline for UTI diagnostics combining an internal process control, QIACube-MDx extraction, Illumina NextSeq sequencing, and the BIOTIA-DX interpretable machine-learning analytic. Trained and benchmarked against clinical culture and qPCR, the workflow improves sensitivity for organisms that are difficult to culture or confirm.

Read publicationDOI: 10.1093/ofid/ofac492.400