Biotia: At-Home Advanced Diagnostics Powering Telehealth for UTI

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 next-generation sequencing (NGS) and proprietary software, Biotia has developed a new UTI test known as the BIOTIA-ID Urine test, which may be a promising alternative to the standard urine culture to identify what is causing your infection, provide insights into drug resistance, and get you on the right treatment path. The BIOTIA-ID Urine test can be accessed via your own doctor or through Biotia’s telehealth partner, who specializes in UTI testing and treatment.

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 the BIOTIA-ID Urine test might help where standard urine culture has failed

The BIOTIA-ID Urine test 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. The BIOTIA-ID Urine test 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. Furthermore, the BIOTIA-ID Urine test provides insight into drug resistance to help guide treatment selection by clinicians.

The BIOTIA-ID Urine test uses a different technique; instead of growing organisms by culturing them, a genomic-based approach is used that leverages next-generation sequencing (NGS) and proprietary software. 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 drug resistance markers 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 the 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, and Karius implemented a clinical metagenomic blood test for sepsis.

Comparison of Standard Urine Culture to BIOTIA-ID Urine:

	Standard Urine Culture	BIOTIA-ID Urine
Sensitivity	50-70%	97%
Specificity	85-99%	99%
Pathogens detected	Limited to the most common pathogens	44 clinically-relevant pathogens
Less common UTI pathogens	No	Yes
Hard-to-culture organisms	No	Yes
Available at home	Sometimes	Yes
Results turnaround	~2–5 days	2–3 business days
Designed for more challenging UTI cases	No	Yes

Download the BIOTIA-ID patient brochure for more information.

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

The BIOTIA-ID Urine test is the only shotgun sequencing-based diagnostic for UTI available nationwide in the US.

Using NGS technology and proprietary software, the BIOTIA-ID Urine test detects and characterizes 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.

The BIOTIA-ID Urine test has been extensively validated to detect the following urogenital pathogens, as well as drug resistance markers (see details below), with additional pathogens being added:

• 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 test 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, this test provides comprehensive results from a single test rather than multiple separate tests, providing important information faster.

Biotia’s test has a 97% sensitivity rate and a 99% specificity rate. This means the test has a high accuracy in detecting organisms and drug resistance and a low incidence of overdiagnosis, which are important in helping clinicians prescribe appropriate antibiotics. 

In clinical studies, the BIOTIA-ID Urine test has shown improved detection of key urogenital pathogens when 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, the BIOTIA-ID Urine test 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 the BIOTIA-ID Urine test. A further 18% of antibiotics prescribed could have been more appropriately tailored to the patient. 

Additionally, the BIOTIA-ID Urine test can detect antimicrobial resistance genes of the organisms identified. If a resistance gene is identified in conjunction with an applicable bacterial species, an extended report is generated outlining the detected antibiotic resistance genes and their associated resistance mechanisms. If evidence of 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) when compared to all other participating methods. Biotia has clinically validated 15 different resistance gene markers that characterize six different antibiotic resistance mechanisms:

• Extended-spectrum beta-lactamases (ESBLs)
• Carbapenamases
• AmpC beta-lactamases
• Folic acid synthesis
• Methicilin
• Vancomycin-glycopeptide

The science behind how BIOTIA-ID Urine works

How does the BIOTIA-ID Urine test work? While there are multiple steps to the 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.

The BIOTIA-ID Urine test uses lllumina’s next-generation sequencing (NGS) technology to sequence all of the nucleic acids (the building blocks of DNA) 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 software to identify urogenital pathogens and resistance genes accurately.

Biotia’s machine learning algorithms are trained on real patient samples, enabling highly accurate detection. As microbial sequences are processed, the algorithms cross-reference 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.

The BIOTIA-ID Urine test was extensively validated on over 900 clinical specimens and isolates to ensure 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

the BIOTIA-ID Urine test 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 through Biotia’s telehealth for UTI service, which is provided by their specialized partner.

Biotia’s integrated care model for complex UTI cases

Biotia has partnered with telehealth provider, Clinova.Solutions, to provide enhanced access to providers with expertise in recurrent or complex UTI cases. These providers can order the test for you, review your results, and recommend a treatment plan either through text message or a virtual telehealth visit. If necessary, they will send any recommended treatment options to your preferred pharmacy. With a strong understanding of both infectious and noninfectious causes of urogenital symptoms, patients will have access to ongoing supportive and preventative urinary care from Clinova.Solutions’ provider team beyond using the BIOTIA-ID Urine test.

How to access testing and treatment:

1. Visit the Biotia website, purchase the BIOTIA-ID Urine test, and receive your test kit in the mail.
2. When experiencing UTI symptoms, activate your test kit and complete your eligibility survey on the Biotia Portal. Clinova.Solutions will approve the eligibility of your order. 
3. Collect your urine sample according to the instructions included in the kit. Ship it to Biotia, using the prepaid shipping materials provided.
4. Within ~3 business days of receiving your sample at the Biotia Laboratory, you and your provider will receive your test results. 
5. At any point, you can schedule a telehealth visit with Clinova.Solutions to review your results, discuss treatment recommendations, and receive a prescription if appropriate. You will also have the option to securely discuss your care via text message.
6. Follow-up appointments can be scheduled as needed.

Learn more about Biotia’s integrated care model.

Ordering via a clinician for in-person UTI care:

If you are already under treatment with a clinician and would like them to consider ordering the BIOTIA-ID Urine test 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 the BIOTIA-ID Urine test with whom you can book an in-person appointment, please see the map on Biotia’s website for options. 

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

For both in-person and 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.

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 the BIOTIA-ID Urine test 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 (must be sent overnight if shipped at ambient temperatures) to the Biotia Laboratory, 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 the BIOTIA-ID Urine test

Collecting a urine sample for the BIOTIA-ID Urine test is like collecting one for any other urine test. Biotia provides collection 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 shipping options. 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 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 send 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 laboratory, an in-depth clinical report of your urine results will be available on the Biotia Portal. Turnaround time for results is typically 3 business days 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 do 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. 

Moreover, if a pathogen is found to have any of the 15 resistance genes that have been validated, this will be shown on your report with a (+) sign as well. Understanding antibiotic resistance is complex; however, Biotia’s telehealth partner has been thoroughly trained to interpret these results to guide discussions about your treatment options. It is important to interpret the report with a clinician in the context of your symptoms, medical history, a physical examination where possible, 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 software, a leading microbial database, and novel sequencing tools to diagnose and fight infectious diseases.

Based in New York, NY, Biotia operates 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, the BIOTIA-ID Urine test 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.