If you have experienced recurrent, chronic, or complicated urinary tract infections (UTI), you’re likely aware of how difficult it is to find a UTI testing method that is reliable and accurate. In the often-fallible world of UTI testing, a potential alternative to traditional testing has become available from the New York-based biotech company, Biotia. 

You can now order the BIOTIA-ID Urine test via your own clinician, or access this advanced diagnostic via Biotia’s telehealth for UTI service, allowing you to collect a sample, attend an online appointment and receive tailored treatment, from home. 

Issues surrounding UTI testing have persisted for decades, and with the increasing risk of antimicrobial resistance, the need for accurate and accessible testing has become even more urgent. Did you know:

• UTIs are the most common outpatient infection in the United States, and are the most common healthcare-acquired infection
• Standard urine culture misses identification of pathogens in 30-50% of cases
• Standard UTI tests do not account for polymicrobial infections with more than two organisms.
• UTIs are a leading driver of antibiotic prescriptions in both outpatient and inpatient settings — with up to 90% of antibiotics prescribed without knowing what pathogen may be causing the infection
• Nearly 25% of sepsis cases originate in the urogenital tract
• New technology, including genomic-based technology, has been developed to test for UTI-causing pathogens often missed by culture

Who is the Biotia-ID Urine Test designed for?

Biotia’s technology aims to provide a comprehensive new solution for those who experience recurrent, chronic or complicated UTIs. By using the power of artificial intelligence (AI) and next-generation sequencing (NGS), Biotia has developed a new UTI test known as BIOTIA-ID Urine, which may be a promising alternative to the standard urine culture to identify what is causing your infection and get you on the right treatment path. BIOTIA-ID Urine can be accessed via your own doctor, or through Biotia’s telehealth for UTI service. 

BIOTIA-ID Urine is for UTI patients who meet one of these criteria: 

1. Have been suffering from recurrent or chronic UTIs (two or more UTIs within 6 months, or three or more UTIs within 12 months)
2. Have an underlying condition that increases the risk of UTI complications, such as diabetes, cancer, kidney disease, or other conditions
3. Recently received negative test results using other UTI tests, but still have UTI symptoms

Why BIOTIA-ID might help where standard urine culture has failed

BIOTIA-ID Urine was designed to address the limitations of the current standard of care: the urine culture. Standard urine culture has poor sensitivity and misses identification of many pathogens that don’t grow well in culture – for example, slow growing pathogens, or pathogens that require specific conditions to grow. BIOTIA-ID Urine is more sensitive and specific and can identify pathogens that standard culture can’t, including those that may be linked to recurrent or chronic UTIs. 

BIOTIA-ID Urine uses a different technique; instead of growing organisms by culturing them, a genomic-based approach is used that leverages next-generation sequencing (NGS) and AI. Biotia processes a urine sample by extracting DNA from the sample, simultaneously determining the DNA sequence of millions of microbial genetic fragments in the sample. 

They then use their proprietary software to compare the sample data to their database, to provide highly accurate pathogen species identification. This process provides information about the microbial composition, drug resistance genes, and virulence, generating many important insights in a single test. This test is one of few now being used to diagnose infection in the emerging field of ‘clinical metagenomics’. For example, Mayo Clinic recently launched a clinical metagenomic test for meningitis.

Comparison of Standard Urine Culture to BIOTIA-ID Urine:

	Standard Urine Culture	BIOTIA-ID Urine
Sensitivity	50-70%	97%
Specificity	85-99%	99%
Identifies less common UTI pathogens	No	Yes

Download the BIOTIA-ID patient brochure for more information.

BIOTIA-ID Urine: A new genomic-based UTI test

BIOTIA-ID Urine is the only shotgun sequencing-based diagnostic for UTI available nationwide in the US. It is the only clinical metagenomic urine test that has met the rigorous standard of the New York State Department of Health and has been approved to sell there. 

BIOTIA-ID Urine uses NGS technology and AI to detect and characterize organisms in a urine sample, comparing the sample data against Biotia’s database of over 7000 microbes. These results are then narrowed down to identify whether any of a list of over 40 known urogenital pathogens are present in the sample.

BIOTIA-ID Urine tests for the following urogenital pathogens:

• Gram-negative Enterobacteriales:
  • Citrobacter species
  • Enterobacter cloacae complex
  • Escherichia coli
  • Klebsiella (Enterobacter) aerogenes
  • Klebsiella oxytoca
  • Klebsiella pneumoniae
  • Klebsiella variicola
  • Morganella morganii
  • Proteus mirabilis
  • Proteus vulgaris
  • Providencia rettgeri
  • Providencia stuartii
  • Serratia marcescens

• Gram-negative non-Enterobacteriales
  • Acinetobacter baumannii-calcoaceticus complex
  • 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

• Fungal species
  • Candida albicans
  • Candida auris
  • Candida dubliniensis
  • Candida glabrata
  • Candida kefyr
  • Candida krusei
  • Candida lusitaniae
  • Candida parapsilosis
  • Candida tropicalis
  • Candida guilliermondii

BIOTIA-ID Urine pathogen detection 

Unlike traditional testing methods such as dipstick testing or urine culture, the BIOTIA-ID Urine detects polymicrobial infections (more than one pathogen), fastidious (difficult-to-culture) organisms, anaerobes (organisms that grow without oxygen), fungi, and slow-growing bacteria in the urine. Using advanced genomic sequencing, BIOTIA-ID Urine provides comprehensive results from a single test rather than multiple separate tests. 

BIOTIA-ID Urine has a 97% sensitivity rate and a 99% specificity rate. This means the test has a high accuracy in organism detection and a low incidence of over-diagnosis, which are important in helping clinicians prescribe appropriate antibiotics.  

In clinical studies, BIOTIA-ID Urine has an improved detection of key urogenital pathogens compared to standard urine culture. In a recent 200 patient study conducted by the Biotia scientific team in collaboration with SUNY Downstate Hospital in Brooklyn, NY, BIOTIA-ID Urine detected pathogens that were missed by culture in 63% of clinical urine samples. 

This outcome has important implications for patients with UTI symptoms who have received a negative culture result. When the research team reviewed patient records, they discovered that 70% of the antibiotics prescribed based on culture were not effective against pathogens detected by BIOTIA-ID Urine. A further 18% of antibiotics prescribed could have been more appropriately tailored to the patient. 

Additionally, BIOTIA-ID Urine uses technology which can detect antimicrobial resistance within the genes of the organisms identified. If resistance to certain antibiotics is detected, treatment recommendations can be tailored for the patient accordingly. 

Biotia’s resistance detection tool achieved the highest prediction accuracy at a recent international conference (CAMDA Antimicrobial Resistance Challenge) compared to all other participating methods. 

The science behind how BIOTIA-ID Urine works

How does BIOTIA-ID Urine work? While there are multiple steps to the BIOTIA-ID Urine process, it all relies on something called ‘shotgun sequencing’. 

Shotgun sequencing, also known as shotgun metagenomic sequencing, is a technique that reads all the genetic material in a sample to identify and analyze every microorganism present—bacteria, viruses, and fungi alike.

BIOTIA-ID Urine uses lllumina’s next-generation sequencing (NGS) technology to sequence all of the nucleic acids (compounds carrying genetic information) in the sample. After sequencing, human genetic material is filtered out, so that only microbial DNA is left. This microbial data is then analyzed using Biotia’s proprietary AI technology to accurately identify urogenital pathogens and resistance genes.

Biotia’s machine learning algorithms are trained on real patient samples, enabling accurate AI-driven analysis. As microbial sequences are processed, the AI cross-references Biotia’s curated pathogen database to distinguish clinically relevant organisms from those that are considered irrelevant to the test. 

Commensal organisms—those that are native to the body and are typically harmless—are filtered out, streamlining interpretation and helping clinicians focus on the pathogens most likely responsible for the infection.

BIOTIA-ID Urine was extensively validated on over 900 clinical specimens and isolates to assure rigorous and standardized clinical-grade results. 

Biotia is currently in the process of submitting an addendum to New York State to include antimicrobial resistance gene markers on their results report. Once that is approved, BIOTIA-ID Urine will be able to further help guide treatment plans by clinically reporting antibiotic resistance from patient samples.

For Patients: How to order the BIOTIA-ID Urine test

BIOTIA-ID Urine is available in all 50 US states, including New York and California. While a clinician needs to be involved in ordering the test, patients can choose to do this through their own doctor, or via Biotia’s telehealth for UTI service. 

Biotia’s telehealth for UTI service

Biotia has partnered with telehealth provider, Clinova.Solutions, whose healthcare providers can order the test for you, conduct a telehealth visit with you to review your results, recommend a treatment plan, and prescribe antibiotics if needed. 

How the telehealth for UTI service works:

1. Visit the Biotia website, click ‘Buy Now’ and fill in the patient questionnaire which will determine your eligibility to order the test.
2. Your responses will be shared with Biotia’s telehealth partner, Clinova.Solutions, and if you are eligible, a test will be ordered on your behalf. 
3. Biotia will then ship a collection kit directly to the address you provided.
4. When the kit arrives, collect your urine sample and ship it to Biotia, using the materials provided.
5. Within 48-72 hours of receiving your sample, Biotia will process your sample and provide you with your results, as well as sharing these with the clinician who ordered the test. 
6. You can then schedule a telehealth visit with Clinova.Solutions to review your results, discuss treatment recommendations and receive a prescription if appropriate.
7. You will then have the option to schedule a follow-up telehealth appointment.

Learn more about Biotia’s telehealth for UTI service.

Ordering via a clinician for in-person UTI care:

If you’re already consulting with a clinician and would like them to order BIOTIA-ID Urine on your behalf, please direct them to the section for clinicians below. You can also download this information sheet to share with your doctor.

To find a clinician who currently uses BIOTIA-ID Urine and can book an in-person appointment, please see the map on Biotia’s website for options. 

If you’re a clinician using BIOTIA-ID Urine who is not yet included in the map, please reach out to Biotia to be added. 

For both in-person or telehealth care, Biotia offers an at-home collection kit, enabling patients to collect a sample from their own home when needed, avoiding additional trips into the doctor’s office. This option also allows patients to keep a collection kit on hand at home, to be used if UTI symptoms arise.

The Biotia team is committed to ensuring accurate and affordable diagnosis and will do their best to accommodate patients both with and without insurance. Contact Biotia to inquire about their discounted self-pay option or any billing inquiries.

For clinicians: How to order the BIOTIA-ID Urine test

Clinicians interested in providing BIOTIA-ID Urine to their patients can order the test via two methods: 

1. Order by creating an online account

To order BIOTIA-ID Urine online, register for an account on the Biotia website using your email address and NPI number. Navigate to the online order page and complete the required fields for both clinician and patient information. 

After submitting the form, print the pre-filled requisition form and ship it with the sample to the Biotia lab, located at:

30-02 48th Avenue

2nd Floor, Suite 260

Long Island City, NY 11101

2. Order using a printable requisition form

Download the requisition form, print and complete the form and include it in the shipment with the urine sample. Biotia accepts samples submitted in standard collection containers and shipping materials. 

Alternatively, collection materials can be provided by Biotia. Place the requisition form in the package with the sample, and ship directly to the lab (see address above). Once the requisition form and sample are received, Biotia will create a clinician account for you, which you should log in to and finalize within 72 hours. This account can then be used for future test orders and to review results.

Contact Biotia with any further questions via email at [email protected] or by phone at (888) 685-2885.

How-to collect a sample for BIOTIA-ID Urine

Collecting a urine sample for BIOTIA-ID Urine is like collecting one for any other urine test. Biotia provides collections kits that can be delivered to a patient’s home, with specific instructions on how to complete sample collection and shipping. For samples collected in a clinic, Biotia works with clinicians to support collection and logistics related to sample transport. The lab accepts urine samples collected via different methods and placed in a urine transport tube (UTT). Collection methods include:

• Clean catch midstream urine in a sterile urine cup
• Samples collected using a catheter – talk to your provider about how to collect a urine sample when you have an indwelling urinary catheter

A clean-catch urine sample means collecting urine in the middle of your urination, which aims to help reduce contamination from skin and external bacteria. To collect a clean-catch sample, begin urinating into the toilet for the first few seconds, then, without stopping the flow, move the collection cup under the stream to collect the sample. 

Once enough urine has been collected, remove the cup from under the stream and continue urinating until your bladder is empty. There’s no need to stop and start urinating. Learn more about how to collect a clean catch sample.

Sending your BIOTIA-ID Urine sample

Once the urine sample is collected into a collection cup, it should be transferred into a urine transport tube (UTT), placed in a biohazard bag, and then secured within a secondary protective container. Biotia provides specific instructions and a shipping label to support sending your sample to the laboratory. When preparing the sample for shipment, be sure to include a completed requisition form in the package.

To preserve integrity, samples stored at room temperature must be received at the lab within 48 hours of collection. If a delay is anticipated, the sample should be refrigerated at 35°F to 46°F (2° to 8°C) and can be stored for up to 7 days. If the sample is refrigerated, it must then be shipped with cold packs to maintain temperature stability.

After the sample is processed at the Biotia lab, an in-depth clinical report of your urine results will be available on the Biotia user portal. Turnaround time for results is typically 36 to 72 hours from the time the laboratory receives the sample.

Reading your results

Once your sample has been processed, your test results will be made available via an online portal. Interpretation of your results should always be completed by a professional healthcare provider.

View an example of Biotia’s test result report.

A quick overview of your results can be found in the results summary section. This section lists what, if any, pathogens were found in your sample. If specific pathogens are identified, their names will be clearly listed.

In the ‘Key Urogenital Pathogens’ section, the report will go into detail about the presence or absence of the 40+ urogenital pathogens assessed by the test. This includes Gram-negative and Gram-positive bacteria (two different types of bacterial cells), anaerobic bacteria (bacteria that does not require oxygen), other bacteria (those not classified as strictly Gram-negative, Gram-positive or anaerobic) and fungi. 

The report lists all the tested bacteria and fungi; each marked with a plus (+) or minus (-) sign. A plus sign indicates that the urogenital pathogen was detected in your urine sample, whereas a minus sign indicates that the pathogen was not found. These results are determined using clinically validated thresholds designed to distinguish potential infections from commensal microbes. This means if any of the urogenital pathogens are detected at levels below this established threshold, they will be marked with a minus (-) sign. 

It is important to interpret the report with a clinician in the context of your symptoms, medical history, a physical examination, and any additional test results, to guide the most accurate and appropriate care.

Who Is Biotia?

Biotia is a health tech company launched from Cornell Tech, on a mission to battle infectious diseases through more advanced diagnostics. By offering advanced diagnostics, the company helps clinicians and patients identify the right treatment to resolve their infections. By getting patients on the right treatment, the misuse of antimicrobials is reduced, thereby addressing the global drug resistance crisis. 

Biotia is the brainchild of Dr. Niamh O’Hara and Dr. Christopher Mason, who have assembled an expert team from multiple eminent universities, including Cornell Tech, Weill Cornell, and Columbia University. With this team, Biotia built proprietary AI software, as well as a leading microbial database, and novel sequencing tools to diagnose and fight infectious diseases.

Based in New York, NY, Biotia has a high complexity CLIA/CLEP laboratory, where it processes all patient samples. New York State has the strictest guidelines and requirements for diagnostic laboratories of any US state, and Biotia is required to ensure consistent excellent laboratory quality. 

Combining advanced technology with rigorous laboratory standards set by New York State and federal regulations, BIOTIA-ID Urine offers a promising new diagnostic and care pathway for individuals living with recurrent, chronic or complicated urinary tract infections.

Are you a clinician already using BIOTIA-ID Urine?

If you’re a clinician who specializes in recurrent, chronic or complicated UTI, we’d love to hear from you. Via our clinician network, we’re able to connect patients with clinicians in their region. We also provide other avenues for clinicians and researchers to share their expertise with the community.