TWO ROBUST TESTS TO HELP MAKE TREATMENT DECISIONS

Guidance Comprehensive Test

For symptomatic patients with:

  • Recurrent, persistent, or complicated UTI, or
  • Interstitial cystitis, or
  • Prostatitis

Guidance Basic Test

For symptomatic patients with:

  • Simple cystitis

PATIENTS THAT WILL BENEFIT MOST FROM GUIDANCE

Infectious patients

  • Recurrent UTI
  • Interstitial cystitis
  • Pyelonephritis
  • Men with UTI

At risk patients

  • Pregnant
  • Elderly
  • On chronic pain care regimens
  • Immunosuppressed
  • Diabetic

GUIDANCE HELPS PHYSICIANS MANAGE CHRONIC INFECTIONS MORE EFFECTIVELY THAN CULTURE



TECHNOLOGY USED – PHENOTYPE AND GENOTYPE TESTING

STEP 1

  • Guidance identifies pathogens in patient’s urine (4-10mL)
  • Technology used: Semi-quantitative, real-time polymerase chain reaction (PCR) amplification

List of Pathogens Detected

KEY: • Guidance Basic and Guidance Comprehensive ■ Guidance Comprehensive Only ◆ Add on Tests

ORGANISMS DETECTED:

Bacterial/Yeast Organisms

  • Acinetobacter baumannii • Corynebacterium regalii ◆ Mycobacterium tuberculosis
  • Actinobaculum schaalii • Enterobacter aerogenes • Pantoea agglomerans
  • Aerococcus urinae • Enterococcus faecalis • Proteus mirabilis
  • Alloscardovia omnicolens • Escherichia coli • Providencia stuartii
  • Candida albicans • Klebsiella oxytoca • Pseudomonas aeruginosa
  • Candida glabrata • Klebsiella pneumoniae • Serratia marcescens
  • Candida parapsilosis • Morganella morganii • Staphylococcus aureus
  • Citrobacter freundii • Mycoplasma hominis • Streptococcus agalactiae
  • Citrobacter koseri ■ Mycoplasma genitalium • Ureaplasma urealyticum

Sexually Transmitted Organisms
◆ Chlamydia trachomatis
◆ Neisseria gonorrhoeae
◆ Trichomonas vaginalis
Bacterial Groups

  • Coagulase Neg. Staphylococci
  • Viridans Group Streptococci

Viral Particles
■ BK virus ■ Adenovirus ■ CMV ■ HSV ■ JC virus

STEP 2

  • Guidance determines antibiotic resistance for detected pathogens for personalized treatment options
  • Exclusive to Guidance: Combination technology used – phenotype and genotype

Phenotype Testing

  • Exposes patient’s urine to different antibiotics to determine antibiotic sensitivity
  • Addresses challenges of polymicrobial infections (more information)
  • Technology used: High throughput spectrophotometry

List of Antibiotic Resistance Testing

POOLED PHENOTYPE ANTIBIOTIC RESISTANCE/SENSITIVITY TESTING INCLUDES:

  • Amoxicillin/Clavulanate (PO) • Ceftriaxone (IM/IV) • Nitrofurantoin (PO)
  • Ampicillin (PO/IV) • Cefuroxime (PO) • Piperacillin/Tazobactam (IV)
  • Ampicillin/Sulbactam (IV) • Cephalexin (PO) • Tetracycline (PO)
  • Cefaclor (PO) • Ciprofloxacin (PO/IV) • Sulfamethoxazole/Trimethoprim
  • Cefazolin (IV) • Gentamicin (IM/IV) (PO/IV)
  • Cefepime (IV) • Levofloxacin (PO) • Vancomycin (IV)
  • Cefoxitin (IV) • Meropenem (IV)
  • Ceftazidime (IV)
Formulations:
Intravenous (IV)
Intramuscular (IM)
Per Oral (PO)

Genotype Testing

  • Detects genes that predict bacterial resistance to certain antibiotics
  • Addresses challenges of pathogens that are slow-growing in culture
  • Technology used: Real-time polymerase chain reaction (PCR) amplification

List of Antibiotic Resistance Genes Testing

POOLED GENOTYPE ANTIBIOTIC RESISTANCE GENES TESTING INCLUDES:

  • Ampicillin • Macrolide • Vancomycin
  • ß-Lactamase • Methicillin
  • Carbapenem • Quinolinone/Fluoroquinolone

STEP 3

Receive test results in generally 1-2 days compared to up to 5 days for urine culture.

Sample test report

Pathnostics developed and determined the performance characteristics of Guidance and conducts the test as a service. This test has not been cleared or approved by the U.S. Food and Drug Administration (FDA). Although the FDA does not currently clear or approve laboratory-developed tests in the U.S., certification of the laboratory is required under CLIA to ensure the quality and validity of the tests.