PrecisionBIOME® for
Women’s Health

PrecisionBIOME® for Women’s Health

PrecisionBIOME® Women’s Health is a molecular diagnostic test that uses next-generation DNA sequencing (NGS) technology for the detection and identification of microorganisms and viruses in vaginal infections. Using the power of NGS, PrecisionBIOME® Women’s Health offers the most comprehensive approach for the diagnosis of vaginal infections available. In one single test, PrecisionBIOME® targets and sequences DNA from bacterial and fungal pathogens in a sample, along with specific viruses, parasites, and antibiotic resistance genes. This way, PrecisionBIOME® eliminates the need for separate tests.

PrecisionBIOME® can also be used to identify asymptomatic or difficult-to-diagnose infections that could otherwise go undetected in generalized PCR panels or more traditional methods of testing for STIs and other genital tract infections. Since asymptomatic bacterial vaginosis and intermediate flora are risk factors for adverse pregnancy outcomes, adequate and timely treatment can have a positive impact on women who are trying to conceive.
The emergence of antibiotic drug resistance has become a major global public health concern, with multidrug resistance detected in sexually transmitted pathogens, particularly Neisseria gonorrhoeae, which has developed resistance to almost every antibiotic used to treat it. Rapid drug resistance has also emerged in Mycoplasma and Ureaplasma species, with Mycoplasma genitalium showing high levels of resistance to first- and second-line treatments.
Prevention and detection are critical to controlling the continued spread of antibiotic-resistant infections. PrecisionBIOME® Women’s Health helps by providing crucial information on pathogen-specific antibiotic resistance.

Replace Separate Vaginal Tract Tests with One Comprehensive Test

PrecisionBIOME® Women’s Health offers a more comprehensive and precise solution, providing the following information in one clear report:

•  Lists of pathogens detected in the sample

•  Comprehensive profiles of bacteria and fungi detected in the sample

•  Relative and absolute abundance of each bacterium and fungi detected

•  Pathogen-specific antibiotic resistance to combat antibiotic-resistant infections

PrecisionBIOME® can be used to detect the relative abundance of causative agents of various sexually transmitted infections including:

•  Neisseria gonorrhoeae

•  Chlamydia trachomatis

•  Mycoplasma genitalium

•  Trichomonas vaginalis

•  Herpes simplex virus 1 and 2

•  Human papillomavirus (HPV) (All HPV Genotypes)

◦  High risk HPV 16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, and 59

◦  Low risk HPV 6, 11, 42, 43, and 44

• Bacterial vaginosis

• Aerobic vaginitis

• Mycoplasma hominis

• Ureaplasma parvum

• Ureaplasma urealyticum

• Candidal vulvovaginitis

PrecisionBIOME® Women’s Health Case Studies

Case 1

A 25-year-old woman with adnexitis (inflammation of the uterine appendages) was found to have a chlamydia infection along with overgrowth of bacteria known to cause aerobic vaginitis (Streptococcus anginosus and E. coli)

Sexually transmitted infections detected:

Name Type Associated Condition
Chlamydia trachomatis Serotype E Cervicitis, urethritis, PID, conjunctivitis.
Human papillomavirus HPV 16（High Risk） HPV 26 Cervical and anogenital cancers

Comprehensive list of bacteria detected:

Species Relative Abundance (%) Absolute Abundance (cells/ml) Associated Condition
Streptococcus anginosus 96.2 34 X 108 Aerobic vaginitis
Escherichia coli 2.78 1.0 X 108 Aerobic vaginitis
Prevotella bivia 0.15 5.4 X 105 Bacterial vaginosis
Chlamydia trachomatis < 0.1 < 0.1 X 105 Sexually transmitted infection
No fungi, Trichomonas, or antibiotic resistance detected.

Bacterial Profiles Of Patient A and a Healthy Female

Patient A's results
Patient A
Normal Vaginal Bacteria

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Case 2

A 32-year-old woman visited the doctor for a routine pap test. Trichomonas was observed microscopically in her specimen, but no other tests were ordered based on this. The patient was then tested with PrecisionBIOME® and was found to have gonorrhea, chlamydia, and trichomoniasis. Fluoroquinolone and sulfonamide resistance were detected in Neisseria gonorrhoeae.

Sexually transmitted infections detected:

Name Associated Condition
Neisseria gonorrhoeae Urethritis, PID, gonococcemia, gonococcal ophthalmia neonatorum
Chlamydia trachomatis Serotype I Cervicitis, urethritis, PID, conjunctivitis.
Trichomonas vaginalis Trichomoniasis

Antibiotic resistance detected:

Class Antibiotic Chlamydia trachomatics Neisseria gonorrhoeae
Cephalosporin Ceftriaxone, cefixime I S
Macrolide Azithromycin S S
Fluoroquinolone Ciprofloxacin S R
Penicillin Penicillin, ampicillin I NT
Sulfonamide Cotrimaxozole NT R
Other Rifampicin S S
S = Sensitive: R = Resistance detected: I = Intrinsic or natural resistance: NT = Not tested

Bacterial Profiles Of Patient B and a Healthy Female

Patient B
Normal Vaginal Bacteria

The Future of Women’s Health Testing Is Here

PrecisionBIOME® offers the next step in precision diagnostics for the often-under-diagnosed area of women’s health. Researchers and medical professionals looking to investigate its potential against traditional diagnostic methods are welcome to order sample test kits from our laboratory today.
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Disclaimers

Test development and performance characteristics were as determined by Pangea Laboratory, LLC.
Detection of most commonly acquired resistance genes and mutations that confer resistance to the different antibiotic classes including Carbapenems, Cephalosporins, Penicillins, Aminoglycosides, Fluoroquinolones, Macrolides, Glycopeptides, Tetracyclines, Sulfonamides, and Rifamycins

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