PrecisionBIOME®
Next Generation Microbial Test
PrecisionBIOME® Next Generation Microbial Test
Rapid
Comprehensive
Precision Medicine
Cost-Effective
Coming Soon: PrecisionBIOME®
PrecisionBIOME® is a molecular diagnostic test that uses Next-generation DNA sequencing (NGS) of microbial DNA present in a clinical specimen, to identify and quantify bacterial and fungal pathogens, as well as certain viral agents present at the site of infection, and accurately identify its cause.
We offer a rapid turnaround time of 3 days or less from receipt of the specimen at our CLIA/CAP laboratory facility in Southern California, so medical providers can deliver more timely care. The same test also provides additional data on markers of antibiotic resistance, aimed at improving patient outcomes through properly targeted treatments. The future of precision medicine is here.
This comprehensive microbial identification test provides accurate and timely diagnostic data for the management of complex infectious conditions of:
Ear, Nose, Throat (Otolaryngology)
Foot and Lower Extremities (Podiatry)
Reproductive Health (Obstetrics and Gynecology)
Wound Care
The PrecisionBIOME® Test comprehensively identifies and quantifies pathogens alongside their antimicrobial resistance profiles, delivering the data doctors need. This microbial test enables them to accurately diagnose and resolve infections quicker and more effectively with precision medicine, improving patient outcomes, and patient satisfaction
PrecisionBIOME® uses a high-quality, targeted NGS workflow and state-of-the-art bioinformatics pipeline that includes a comprehensive and ever-growing database of reference sequences for bacterial and fungal species. The test can detect pathogens with 99% accuracy and 100% sensitivity, including those that are difficult to grow and unculturable organisms for a thorough, unbiased detection of infectious agents present in the specimen.
PrecisionBIOME® testing is highly useful when applied in cases of acute infections, for early and rapid determination of the causative agents behind an infection, driving the best treatment decisions from the start for better patient outcomes. For example, medical providers will now have the right information to be able to choose between antibiotic or anti-fungal therapy, without prescribing the wrong treatment. The test can also be extremely impactful for patients with chronic or recurrent infections, or where culture testing has delivered negative or inconclusive results.
Contact us to learn more or to order kits to try at your practice
NGS vs Culture Testing in Diagnostics
Compared to culture testing, PrecisionBIOME® is faster, cost-effective, and more comprehensive. The test delivers precise, clinically actionable data in one timely report, as supposed to having to utilize multiple, consecutive tests to obtain an accurate diagnosis and confident treatment options.
PrecisionBIOME® |
Culture Tests |
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|---|---|---|
| Detects all microbes present in the specimen |
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A minority of microbes can be successfully cultured
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| Specimen collection at ambient temperature, stable for up to a month |
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Requires cold storage and immediate shipment to a lab following collection
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| Identifies aerobic and anaerobic bacteria, fungi, and antibiotic susceptibilities, all in one test |
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Multiple tests are required to identify different microbes
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| Results available in 3 days or less |
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Quick turnaround for certain bacterial cultures and antibiotic susceptibility
Takes up to 4 to 6 weeks to get results for fungal cultures
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How the PrecisionBIOME® Test Works
Step 1
Clinical specimen is collected and shipped to our California-based CLIA CAP laboratory
For Ear, Nose & Throat infections: Two sterile swabs, one for nasopharyngeal and another for oropharyngeal sampling, are provided with each collection kit. These are used to sample the affected area and the swab is placed directly inside a collection tube containing a nucleic acid preserving solution. The swab stem is broken off and discarded. The tube is capped tightly and prepared for shipping. Specimen types may also include nasal/sinus aspirates, washes, and sputum that can be placed directly inside the provided collection tube.
For Wounds/Skin infections: A sterile swab and a collection tube for sampling the affected area are provided with each collection kit. Punch or tissue biopsies may also be collected and deposited inside the collection tube.
For Urogenital infections: Depending on the sample type, the collection kits may differ. A sterile swab will be included for vaginal collection, which will need to be placed inside the collection tube after sampling the affected area. For urine or semen collection, a sterile collection cup will be included – the sample will need to be mixed with the provided sterilizing and preserving solution.
Specimens can be stored at room temperature for up to 30 days. There is no need for cold storage. The sterilizing preservative solution contained in the collection tubes stabilizes the microbial DNA contained in the specimen and protects its integrity until specimens are processed thus preserving the original microbial profile.
Step 2
Microbial DNA is extracted from the specimen
Step 3
NGS Library preparation and Sequencing
We follow CLIA / CAP guidelines for clinically validating our NGS workflow
Step 4
Bioinformatic Analysis
Bacterial and fungal species identification to identify the etiologic agent of the infection.
Below is a list of some clinically relevant organisms that have been validated in-silico:
– Actinomyces species
– Anaerococcus species
– Acinetobacter baumanii/iwoffii
– Actinomyces species
– Anaerococcus species
– Bacillus anthracis
– Bacteroides species
– Bordetella species
– Borrelia species
– Brevibacterium species
– Brucella species
– Burkholderia species
– Campylobacter species
– Chlamydia pneumoniae/trachomatis
– Citrobacter species
– Corynebacterium species
– Dialister species
– Eikenella corrodens
– Enterococcus faecalis/faecium
– Escherichia coli
– Fingegoldia Magna
– Fusobacterium nucleatum
– Gemella species
– Haemophilus influenzae
– Klebsiella species
– Leptospira species
– Moraxella species
– Morganella morganii
– Mycobacterium species
– Mycoplasma pneumoniae
– Neisseria species
– Nocardia species
– Parvimonas species
– Peptoniphilus species
– Prevotella species
– Pseudomonas aeruginosa
– Raoultella ornitholytica/planticola
– Rothia species
– Salmonella enterica
– Schaalia species
– Serratia macescens
– Staphylococcus aureus
– Stenotrophomonas maltophilia
– Streptococcus species
– Streptomyces species
– Veillonella parvula
– Weeksella virosa
– Altenaria species
– Aspergillus species
– Acremonium species
– Altenaria species
– Aspergillus species
– Aureobasidium melanogenum/pullulans
– Bipolaris species
– Candida species
– Chaetomium species
– Conidiobolus species
– Cryptococcus species
– Cunninghamella species
– Corvularia species
– Fusarium species
– Humicola species
– Lichtheimia specia
– Microascus species
– Mucor species
– Naganishia species
– Penicillium species
– Pneumocystis carinii/jirovecii
– Rhizopus species
– Rhodotorula species
– Saksenaea species
– Talaromyces marneffei/purpureogenus
– Trichoderma species
– Trichosporon species
Step 5
Medical Providers will receive an actionable clinical report
– Pathogen ID including bacterial and fungal pathogens, and some viruses and parasites
– List of pathogens in order of most to least abundant, and comparisons with the microflora of a healthy individual
– Antibiotic resistance genotypes for targeted, effective treatments
– Comprehensive microbial detection of bacterial and fungal organisms that are present in the specimen
– Reference to publications supporting infectious potential of detected microbes
– Clinical guidelines for antibiotic and anti-fungal therapies as found in CLSI-M100, the Sanford Guide, and literature reviews to facilitate more effective, pathogen-specific treatments
“This test has been extremely helpful… it has provided both the quantitative analysis of organisms present and determination of fungal presence, which standard culture has difficulty accomplishing”
–
Charles Oh, MD (Otolaryngologist)
“Results from this test sometimes corroborate findings on a regular culture, sometimes augment findings, and sometimes find things that a regular culture didn’t find. Overall, I would say that PrecisionBIOME® results are always helpful in guiding treatment.”
– Sherry Roth, PA-C, DF-AAPA (Wound Care)
The Science of PrecisionBIOME®
PrecisionBIOME® is being extensively studied across a wide range of medical specialties, from Otolaryngology to Wound Care. It has already been featured in several peer-reviewed publications:
A Single-Center Pilot Study Investigating the Effects of a Native Cross-Linked Extracellular Matrix with Polyhexamethylene Biguanide to Manage Chronic Lower Extremity Wounds Exhibiting Bacterial Contamination by Cole, W., Krumbeck, J., et al. (2023)
Effect of argon plasma pre-treatment of healing abutments on peri-implant microbiome and soft tissue integration: a proof-of-concept randomized study by Canullo, L., Rakic, M., et al. (2023)
The adult microbiome of healthy and otitis patients: Definition of the core healthy and diseased ear microbiomes by Burton M., Krumbeck J., et al (2022)
Importance of Microbiome of Fecal Samples Obtained from Adolescents with Different Weight Conditions on Resistance Gene Transfer by Navarro A., Rodea G., et al (2022)
Uromycobiome in infants and toddlers with and without urinary tract infections by Forster C., Liu H., et al (2022)
Learn More About PrecisionBIOME®
Interested in learning more about PrecisionBIOME®?
We invite OB-GYNs, Fertility Clinics, Primary Care Physicians, and Urgent Care Physicians to order and try our diagnostic kits for women’s health to experience the advantages of PrecisionBIOME® in patient care themselves.
Fill out our contact form to order your complimentary test kits today.
Information provided by this test is for research purposes only.
PrecisionBIOME Disclaimers
Information provided by this test is for research purposes only.
PrecisionBIOME® is a molecular test that uses Next-generation DNA sequencing (NGS) and a bioinformatics pipeline to identify molecular signatures unique to a specific microbe. This test is intended for the microbial analysis of clinical specimens to identify the etiologic agent(s) of infection. This test is best administered prior to implementation of any antimicrobial therapy and when there are clear signs of infection.
This test detects bacterial and fungal species that may be present in a clinical specimen together with the detection of some viruses and parasites. Microbial species detected with this test may or may not be the cause of the infection. Data from this test should be considered together with additional clinical information gathered by the physician e.g. physical examination, patient medical history, etc.
This test also provides detection of the most common antibiotic resistance genes and mutations known to confer resistance to the different antibiotic drug classes including Carbapenems, Cephalosporins, Penicillins, Aminoglycosides, Fluoroquinolones, Macrolides, Glycopeptides, Tetracyclines, Sulfonamides, and Rifamycins. Detection of an antibiotic resistance gene or mutation may or may not always translate into antibiotic resistance as these genes may not be phenotypically expressed. Microorganisms may also have additional or unknown resistance mechanisms which are not screened for in this test.