BIOTIA-ID FAQs

About Biotia

Who is 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.

What does the BIOTIA-ID test do?

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.

How does the BIOTIA-ID test work?

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.

What kind of sequencing technology Biotia uses?

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

What kind of specimen types Biotia uses?

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.

What kind of diseases Biotia is testing for?

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.

Why to choose BIOTIA-ID for my patient?

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

How do I order a test for my patient?

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.

How do I receive a result for my patient?

Results are available in the Biotia portal. Please review the step-by-step intructions here on how to receive and interpret your results.

How long does it take to receive BIOTIA-ID 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.

How do I contact Biotia if I have any questions or need support ordering and result interpretation?

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

What does BIOTIA-ID Urine NGS Assay test for?

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

For what patients is BIOTIA-ID Urine NGS Assay useful?

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.

How BIOTIA-ID Urine NGS Assay is comparable to current standard of care?

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.

Is BIOTIA-ID Urine NGS Assay an approved diagnostic tool for patient testing?

The BIOTIA-ID Urine NGS Assay has been clinically validated and is pending New York State LDT (laboratory developed test) approval.

Specimen

What type of samples BIOTIA-ID Urine NGS Assay is using?

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.

What specimen collection devices are acceptable for testing?

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.

How do I store the sample prior to shipping?

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.

How do I ship specimens to Biotia laboratory?

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

How do I order a test for my patient?

Physicians can order tests through the BIOTIA portal. Click here for step-by-step instructions on how to use our Biotia Portal.

What does it mean my specimen was rejected?

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
How much does a test cost?

Please contact us for more details on pricing.

Is the test covered by major insurance companies?

Reimbursement coverage is pending. Please contact us for more information.

Results

How do I receive a result for my patient?

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

How long does it take to receive BIOTIA-ID Urine NGS Assay results?

The clinical report for the BIOTIA-ID Urine NGS assay is available 48 hours after sample receipt.

What is included in the final report?

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.

What does it mean a pathogen was detected?

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.

What does it mean no pathogens were detected?

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.

What does an 'invalid' report mean?

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.