Clinician Support

Biotia is a healthtech company launched from Jacobs Technion-Cornell Institute at Cornell Tech. Biotia leverages next-generation sequencing (NGS)-based technology and proprietary AI-powered software to rapidly and accurately identify microorganisms and antimicrobial resistance. Biotia has a CLIA/CLEP certified diagnostic laboratory affiliated with SUNY Downstate located in Long Island City, Queens, NY.

BIOTIA–ID refers to our platform approach to infectious disease diagnostics. This includes both our next-generation sequencing (NGS)-based approach in addition to our proprietary AI-powered software used to identify microorganisms and antimicrobial resistance. BIOTIA-ID, is being validated for use on a wide range of specimen types for different diagnostic purposes.

The BIOTIA-ID Urine NGS Assay was developed to improve the diagnosis of urogenital pathogens. This assay is intended as an aid to diagnose urinary tract infections, especially recurrent and complicated UTIs and diagnose symptomatic UTI patients with negative culture or who are at high risk to develop sepsis.

The BIOTIA-ID test is a next-generation sequencing (NGS)-based diagnostic tool that is able to detect key pathogens and antimicrobial resistance from different specimen types utilizing a metagenomic database of over 7,000 clinically-validated pathogens. BIOTIA-ID was designed to support clinicians in optimizing drug therapy for patients with suspected infections. The BIOTIA-ID test is a rapid, highly accurate and sensitive test that provides comprehensive detection of multiple pathogens and resistance profiling with one test.

Biotia takes a genomics-based diagnostic approach, utilizing next-generation sequencing (shotgun metagenomic) techniques that can rapidly identify microbes and resistance with high accuracy and sensitivity.

BIOTIA-ID has been optimized and clinically validated for urine specimens, however different specimen types can also be tested including sterile fluids (joint fluid, cerebrospinal fluid, etc.) and stool. Contact Biotia for more details on testing different specimen types.

Biotia currently offers the BIOTIA-ID Urine NGS assay, which tests for 40+ pathogens directly linked to urinary tract infections. Contact us for more details using BIOTIA-ID in different infections as a research use only tool.

Biotia currently offers the BIOTIA-ID Urine NGS Assay, which tests for 40+ pathogens directly linked to urinary tract infections. For a full list, visit here. Alternately, download the list here. Contact us for more details using BIOTIA-ID in different infections/specimen types as a Research Use Only (RUO) tool.

Current infectious disease detection technology has a high failure rate and limited utility. Culturing is slow, labor intensive, misses many species, and requires multiple tests to characterize pathogens and drug resistance. PCR-based assays can only provide insights for hypothesis-driven diagnostics and don’t provide information on drug resistance.

BIOTIA-ID is a precision infectious disease detection toolkit that uses next-generation sequencing (NGS) and artificial intelligence to reveal a comprehensive microbial (bacteria, viruses, fungi, protozoa) profile and antibiotic resistance.

After receipt of a patient specimen, our laboratory prepares the sample and runs the test using next-generation sequencing. Through this approach, we are able to create millions of copies of the DNA/RNA in a sample. Following this, our bioinformaticians analyze the data using our AI-powered software – comparing the results to a reference database of over 7,000 clinically-relevant microorganisms. The end result is an easy-to-digest report detailing which microorganisms were detected in a given sample.

Clinicians may order a BIOTIA-ID Urine test through the Biotia portal. Step-by-step instructions on how to order a test may be found here.

Guidelines on how to send specimens to Biotia may be found here.

Results are available in the Biotia portal. Please review the step-by-step instructions here on how to receive and interpret your results. A template report may be found here.

The clinical report for the BIOTIA-ID Urine NGS assay is available within 36-72 hours after sample receipt. Additional sample types are tested under Research Use Only (RUO) and may take longer to receive results. Please contact us for more details prior to placing an order.

Please contact us at (888) 685-2885 with any questions. Phone support is available during regular business hours (Monday through Friday 8 AM to 5 PM EST).

Alternatively feel free to email us at info@biotia.io or submit a form.

Biotia accepts many major insurance plans (including Medicare and private payers) and will submit claims directly to your patient’s insurance provider after results are delivered. Coverage and patient responsibility (including deductible, coinsurance, or copay) are determined by the insurer. If there is a remaining balance, patients are only responsible for a portion not covered by insurance, which is capped at a fixed, affordable amount.

If Biotia is not in-network with a patient’s insurance, we offer a discounted self-pay option. For questions about coverage, we encourage patients to contact their insurance provider directly. For more information about our billing policies or balance-bill fixed cap, please contact our Billing Department at (888) 685-2885 or clinicalsupport@biotia.io. Biotia is committed to transparent and patient-friendly billing.

The BIOTIA-ID Urine NGS Assay tests for the following key urogenital pathogens:

‍Gram-Negative Enterobacteriales

Citrobacter species, Enterobacter cloacae complex, Escherichia coli, Klebsiella (Enterobacter) aerogenes, Klebsiella oxytoca, Klebsiella pneumoniae complex, Klebsiella variicola, Morganella morganii, Proteus mirabilis, Proteus vulgaris, Providencia rettgeri, Providencia stuartii, Raoultella ornithinolytica, Serratia marcescens

‍Gram-Negative Non-Enterobacteriales

Acinetobacter calcoeticus-baumannii complex (ACB 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

The BIOTIA-ID Urine NGS Assay was developed to improve the diagnosis of uropathogens. This assay is intended as an aid to diagnose urinary tract infections, complicated UTIs, acute pyelonephritis, acute bacterial prostatitis, and urosepsis.

This advanced diagnostic test helps clinicians treating symptomatic UTI patients with a negative urine culture, immunocompromised patients at an increased risk for urosepsis, and patients with recurrent or complicated urinary tract infections.

BIOTIA-ID Urine NGS Assay provides improved diagnosis for patients with suspected urinary tract infection, with increased sensitivity and specificity when compared to the current standard of care (urine culture). In addition, BIOTIA-ID Urine NGS Assay is able to detect pathogens that are often missed (fastidious bacteria, anaerobes, fungi, etc.) by urine culture.

The BIOTIA-ID Urine NGS Assay has been approved by New York State Department of Health’s Clinical Laboratory Evaluation Program as an in vitro diagnostic laboratory developed test (LDT). This assay was developed and its performance characteristics determined by Biotia.

Samples should be collected as clean catch midstream urine specimen collected in a sterile urine cup and transferred into a urine culture transport tube (UTT). Invasively collected specimens, such as those collected by a suprapubic catheter or from the renal pelvis, are also acceptable, and should be transported in a UTT.

The following specimen collection devices may be used in accordance with the manufacturer’s instructions:

• A sterile container can be used to collect urine specimens (2-4mL/cc).
• Urine Culture Transport Tube (UTT) is used for storage and transportation.

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.

Once you order a BIOTIA-ID Urine NGS Assay test, place the specimen in a biohazard bag with absorbent paper, and place it into a secondary container before transporting. Place the bag in a UN3373 Category B Pack if mailing specimen. Transportation of patient samples must comply with all applicable governing regulations for the transport of etiologic agents. Contact us for more information on setting up courier service for your specimens, or ship specimens directly to our lab using the laboratory address. A quick guide on shipping information is available here.

Clinicians may order a BIOTIA-ID Urine test through the Biotia portal. Step-by-step instructions on how to order a test may be found here.

If a specimen was rejected, it had not met the following criteria for an acceptable criteria.

Specimens may be rejected for testing if:

• Samples exceeding stability requirements
• Incorrect or expired collection device
• Incorrect specimen source
• Specimen collection container is broken or leaking
• Unlabeled specimens
• Unidentifiable specimen with insufficient or incorrect information
• Insufficient volume

Results are available on the BIOTIA portal. The system will automatically notify you once the results are available for review.

The clinical report for the BIOTIA-ID Urine NGS assay is available 36-72 hours after sample receipt.

The clinical report includes all detected and not detected pathogens that were tested by the BIOTIA-ID Urine NGS Assay. Please see a clinical report here.

If a pathogen was detected then it was confirmed to be present in the patient sample detected by the BIOTIA-ID Urine NGS Assay. The reported microbial organisms may or may not be the cause of symptoms or disease. The report should be interpreted within the context of clinical information, medical history, epidemiological findings, and other laboratory results.

If no pathogens were detected it means that none of the pathogens targeted by BIOTIA-ID Urine NGS assay were present in the patient sample. The report should be interpreted within the context of clinical information, medical history, epidemiological findings, and other laboratory results.

There are two reasons why an "Invalid Report” is generated: (1) The specimen did not meet our minimal acceptance criteria and was rejected upon receipt. (2) The specimen did not meet our internal quality control standards during its testing.