BIOTIA-ID FAQs
About Biotia
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 Brooklyn, NY.
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 (NGS) techniques that can rapidly identify microbes and resistance with high accuracy and sensitivity.
Clinical
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 30+ pathogens directly linked to urinary tract infections. Contact us for more details using BIOTIA-ID in different infections as a research use only 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.
Logistics
Physicians can order tests through the Biotia portal.
Please review the step-by-step instructions here on how to order BIOTIA-ID via the Biotia Portal.
Results are available in the Biotia portal. Please review the step-by-step intructions here on how to receive and interpret your results.
The clinical report for the BIOTIA-ID Urine NGS assay is available within 48 hours after sample receipt. Additional sample types are tested under research use only 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 9 AM to 6 PM EST).
Alternatively feel free to email us at info@biotia.io or submit a form.
BIOTIA-ID Urine NGS Assay FAQs
Testing
The BIOTIA-ID Urine NGS Assay tests for the following key urogential pathogens:
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
Fungal Species
Candida albicans, Candida auris, Candida dubliniensis, Candida glabrata, Candida keyfr, 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.
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 (anaerobes etc.) by urine culture.
The BIOTIA-ID Urine NGS Assay has been clinically validated and is pending New York State LDT (laboratory developed test) approval.
Specimen
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 are used for the BIOTIA-ID Urine NGS Assay. The patient preparation and specimen collection should follow the manufacturer instructions.
Urine Culture Transport Tube (UTT), Gray top or yellow top tubes with appropriate volume (≥ 4mL/cc). A sterile container can also be used to collect urine specimens (2-4mL/cc). The patient preparation and specimen collection should follow the manufacturer instructions.
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.
Once you ordered a BIOTIA-ID Urine NGS Assay test, place specimen in a biohazard bag before transporting. Specimens should be shipped at a cool temperature (2°C - 8°C). 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. Contact us for more information on setting up currier service for your specimens.
Ordering
Physicians can order tests through the BIOTIA portal. Click here for step-by-step instructions on how to use our Biotia Portal.
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
Please contact us for more details on pricing.
Reimbursement coverage is pending. Please contact us for more information.
Results
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 48 hours after sample receipt.
The final 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.