Problems we solve
UTIs are the most common microbial infection.
30% of cases go undiagnosed.
in costs to the US annually.
30% of sepsis cases originate from the urogenital tract.
emergency dept. visits annually.
annual emergency department bill for complicated UTIs.
At a glance
Optimized antimicrobial treatment
Allows for an optimized therapeutic approach based on the unique microbial profile found in your patient’s sample.
More accurate and sensitive than culture
With 97% sensitivity, 99% specificity and a limit of detection <10,000 CFU/mL.
Reflex test for culture negative samples
Designed for high-risk patients with recurrent and complicated UTIs as a reflex test for culture negative specimens.
Detects 30+ pathogens known to cause urinary tract infections, including fastidious bacteria and anaerobes, fungi, as well as polymicrobial infections.
BIOTIA-ID Urine NGS Assay featuresView sample report
Biotia operates from a NYS CLIA/CLEP Laboratory located in Brooklyn, NY.
Easy ordering through our user friendly online portal for physicians and patients.
The BIOTIA-ID Urine NGS Assay is a qualitative next-generation sequencing (NGS)-based in-vitro diagnostic test powered by BIOTIA-DX software. The assay detects clinically-relevant urogenital pathogens from a comprehensive database of 7000+ clinically-curated microbes.
Optimized with standard urine collection methods. Samples should be collected as clean catch mid-stream urine specimen collected in a sterile urine cup or urine culture transport tube (UTT) or invasively collected specimens such as those collected by suprapubic catheter or from the renal pelvis.
Direct billing and insurance pending.
Klebsiella (Enterobacter) aerogenes
Mitis Group Streptococci
Other Staphylococcus species
Other Staphylococcus Species
ASM 2023: Highly Accurate and Reliable Next-Generation Sequencing-Based Urine Assay Overperforms Conventional Diagnostics
Utilization of Clinical-Grade Metagenomics in Urinary Tract Infection Diagnostics: Improving High-Risk Patients’ Outcomes with a Genomic-Based Assay
ID Week 2022: Clinical-Grade Metagenomics in Urinary Tract Infections: Improving Performance of Next-Generation Sequencing Assays Using Internal Controls and Machine Learning
"This cutting-edge technology allows for more precise and timely identification of atypical urogenital pathogens that often evade standard testing methods. By bridging this diagnostic gap, NGS technology may become an invaluable tool in tailoring targeted and effective treatment plans, ultimately elevating the standard of care for our most vulnerable patients suffering from complicated and recurrent UTI."
Vice Chair, Department of Medicine
Director, Division of Infectious Diseases
SUNY Downstate Health Sciences University,
Kings County Hospital Center
Contact us for more information
Instructions and materials
- The BIOTIA-ID Urine NGS Assay is a qualitative next-generation sequencing (NGS)-based in-vitro diagnostic test powered by BIOTIA-DX software. The assay detects nucleic acid of a panel of common, clinically-relevant uropathogens in unpreserved urine. The identification of specific pathogen DNA in samples from patients with signs and symptoms of urinary tract infection caused by bacteria helps to diagnose these infections in conjunction with other clinical or laboratory findings. Detection of the reported microbial organisms should be interpreted within the context of clinical information, medical history, epidemiological findings, and other laboratory results.
- BIOTIA-ID Urine NGS Assay detects Gram-Negative Enterobacteriales (Citrobacter species, Enterobacter aerogenes, Enterobacter cloacae, Escherichia coli, Klebsiella oxytoca, Klebsiella pneumoniae, Klebsiella variicola, Morganella morganii, Proteus mirabilis, Proteus vulgaris, Providencia rettgeri, Providencia stuartii, Raoultella ornithinolytica, Serratia marcescens), Gram-Negative Non-Enterobacteriales (Acinetobacter baumanii, Acinetobacter lwoffii, Pseudomonas aeruginosa, Stenotrophomonas maltophilia), Gram-Positive Bacteria (Aerococcus species, Anginosus-Group Streptococci, Corynebacterium urealyticum, Enterococcus faecalis, Enterococcus faecium, Staphylococcus aureus, Staphylococcus epidermidis, Staphylococcus lugdunensis, Staphylococcus saprophyticus, Other Staphylococcus species, Streptococcus agalactiae, Mitis-Group Streptococci), Anaerobic Bacteria (Anaerococcus vaginalis, Bacteroides fragilis, Prevotella species), Other Bacteria (Gardnerella vaginalis), and Fungal Species (Candida albicans, Candida auris, Candida dubliniensis, Candida glabrata, Candida kefyr, Candida krusei, Candida lusitaniae, Candida parapsilosis, Candida tropicalis, Candida guilliermondii ).
- Proper collection, preparation and handling of specimen is required to ensure accurate test results.
- Samples should be collected as clean catch mid-stream urine specimen collected in a sterile urine cup or urine culture transport tube (UTT) or invasively collected specimens such as those collected by suprapubic catheter or from the renal pelvis.
- Specimens in sterile cups are stable for up to 24 hours at room temperature or up to 72 hours when stored at 2°C to 8°C, Specimens in UTT are stable for up to 48 hours at room temperature or for up to 1 week when stored at 2°C to 8°C.
- Place specimen in a biohazard bag before transporting.
- Place the bag in a FedEx UN3373 Category B Pack if mailing specimen.
- Transportation of patient samples must comply with all applicable governing regulations for the transport of etiologic agents.
The BIOTIA-ID Urine NGS Assay is currently under review by NYS as an in vitro diagnostic laboratory developed test (LDT). This assay was developed and its performance characteristics determined by Biotia. The assay has not been cleared or approved by the FDA, nor is it required to be. The Biotia Laboratory is certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA ’88) and is accredited to perform high-complexity clinical laboratory testing.