Next Generation Microbial Test

PrecisionBIOME® Next Generation Microbial Test

Precision Medicine

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
Ear, Nose, Throat (Otolaryngology)
foot and lower extremities
Foot and Lower Extremities (Podiatry)
reproductive health icon
Reproductive Health (Obstetrics and Gynecology)
wound care
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.

Aerobic and anaerobic bacteria cultures, antibiotic susceptibility tests, fungal cultures, and mycobacterium cultures are all separate tests that medical providers may order to diagnose an infection. In contrast, the PrecisionBIOME® Test can deliver all this information in ONE test and within 3 days of receiving the specimen at our laboratory.
PrecisionBIOME® offers more precise and comprehensive microbe identification, with higher diagnostic value, over traditional culture methods:


Culture Tests

Detects all microbes present in the specimen
A minority of microbes can be successfully cultured
Specimen collection at ambient temperature, stable for up to a month
Requires cold storage and immediate shipment to a lab following collection
Identifies aerobic and anaerobic bacteria, fungi, and antibiotic susceptibilities, all in one test
Multiple tests are required to identify different microbes
Results available in 3 days or less
Quick turnaround for certain bacterial cultures and antibiotic susceptibility
Takes up to 4 to 6 weeks to get results for fungal cultures

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:

– Acinetobacter baumanii/iwoffii
– 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

– Acremonium species
– 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

– Human papillomavirus (HPV, all genotypes)
– Herpes simplex virus 1 (HSV-1)
– Herpes simplex virus 2 (HSV-2)

– Trichomonas vaginalis

For the detection of a specific pathogen not on this list, please contact Pangea Laboratory’s Customer Service at prior to submitting a specimen.

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)

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.


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