GUIDANCE
RECURRENT, PERSISTENT, OR COMPLICATED UTI • PROSTATITIS • SIMPLE OR INTERSTITIAL CYSTITIS
Now there’s a better way to test and treat chronic urologic infections.
Today’s standard of care simply isn’t good enough. Typical urine culture misses up to 2/3 of all UTI-positive patients, and it detects organisms in only 4% of the cases to diagnose prostatitis.1,2
SWIFT DIAGNOSIS AND THERAPY OPTIONS
Guidance is a unique rapid molecular test for both pathogen identification and 
antibiotic sensitivity, backed by patented technology.
With quick 24-48 hour turnaround, Guidance provides personalized therapy options 
that work the first time. So you can conquer your patients’ unresolved infections.
KNOW WHAT'S CAUSING THE PROBLEM
Organism identification
  • Tests for more pathogens
  • Higher sensitivity and accuracy
  • Results in more accurate diagnosis
KNOW HOW TO SUCCESSFULLY TREAT
Genotype resistance
+
Antibiotic sensitivity
  • Tests more antibiotics
  • Leverages dual assessments
  • Uncovers more effective, personalized therapy options
Organism identification
  • Tests for more pathogens
  • Higher sensitivity and accuracy
  • Results in more accurate diagnosis
Genotype resistance
+
Antibiotic sensitivity
  • Tests more antibiotics
  • Leverages dual assessments
  • Uncovers more effective, personalized therapy options

PATIENTS WITH:

  • Recurrent UTI
  • Interstitial cystitis
  • Pyelonephritis
  • Prostatitis

AT-RISK GROUPS:

  • Pregnant
  • Elderly
  • Past urinary culture results were “contaminated”
  • On chronic pain care regimens
  • Immunosuppressed
  • Diabetic
  • Men with UTI

GUIDANCE BASIC

Tests for:

  • Simple cystitis

Includes detection of:

  • Bacterial and yeast organisms
  • Bacterial groups
  • Antibiotic resistance genes

GUIDANCE COMPREHENSIVE

Tests for:

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

Includes detection of:

  • Bacterial and yeast organisms
  • Bacterial groups
  • Viral particles
  • Antibiotic resistance genes
SEE WHY GUIDANCE IS
SUPERIOR TO STANDARD CULTURE
Relying on urine culture to diagnose chronic urinary infections has significant shortcomings. By leveraging a novel molecular and antibiotic sensitivity test, Guidance points the way to more therapy options for better patient outcomes.
Guidance demonstrates a 26% increase in sensitivity.3
Guidance
Urine Culture
Positive Cases
200
148
Percentage Sensitivity
97%
71%
Guidance improves diagnostic accuracy by more than 65%.3
Guidance
Urine Culture
Number Misdiagnosed
7
142
Percentage Misdiagnosed
4%
69%
Guidance detects 61% more organisms than culture (actual exposure of patient specimen to antibiotic).3
Guidance
Urine Culture
Number Detected
423
159
Percentage Detected
97%
36%
Guidance identifies antibiotic resistance genes from DNA through genotype testing (identification of pathogen DNA within pool of DNA isolated from detected organisms).

Challenge
1
Missed Diagnosis
Standard urine culture misses up to 2/3 of all UTI-positive patients.1

Guidance demonstrates a 26% increase in sensitivity.3
Guidance
Urine Culture
Positive Cases
200
148
Percentage Sensitivity
97%
71%


Guidance improves diagnostic accuracy by more than 65%.3
Guidance
Urine Culture
Positive Cases
7
142
Percentage Sensitivity
4%
69%

Challenge
2
POLYMICROBIAL INFECTIONS
In populations 65 and older, the mortality rate for patients with symptomatic UTIs is as high as 33%.4 And the rate of polymicrobial UTIs is as high as 39%.5

Guidance detects 61% more organisms than culture by determining antibiotic sensitivity through phenotype testing (actual exposure of patient specimen to antibiotic).3
Guidance
Urine Culture
Number Detected
423
159
Percentage Detected
97%
36%

Challenge
3
SLOW-GROWING PATHOGENS
Urine culture is less likely to detect pathogens that are difficult or slow to grow in culture, making treatment unnecessarily challenging.

Guidance identifies antibiotic resistance genes from DNA through genotype testing (identification of pathogen DNA within pool of DNA isolated from detected organisms).

Guidance is the best of both worlds
Only Guidance combines both genotype resistance testing and antibiotic sensitivity on the collection of pathogens to identify effective therapy choices in a polymicrobial environment.
Three reasons why genotype resistance testing alone isn’t enough:

 

Too many resistance genes to put in one assay

Scientists have identified tens of thousands of resistance genes, impacting hundreds of antibiotics in hundreds of organisms.6 Unfortunately, there is a limited number of resistance genes that can be identified via molecular assay.

resistance genes continuously evolve and are shared

Bacteria generate new resistance genes and then transfer those genes to other bacteria on a regular basis. So the ability to identify and characterize new resistance genes will always lag behind bacteria’s capability to create them.7

Resistance gene may not be Functional

Even after the gene is characterized, the actual presence of the resistance gene doesn’t guarantee the gene is functional and exerting resistance within the detected pool of bacteria.8

Scientists have identified tens of thousands of resistance genes, impacting hundreds of antibiotics in hundreds of organisms.6 Unfortunately, there is a limited number of resistance genes that can be identified via molecular assay.

Bacteria generate new resistance genes and then transfer those genes to other bacteria on a regular basis. So the ability to identify and characterize new resistance genes will always lag behind bacteria’s capability to create them.7

Even after the gene is characterized, the actual presence of the resistance gene doesn’t guarantee the gene is functional and exerting resistance within the detected pool of bacteria.8

here’s how you access your
personalized therapy options
clinical utility

Pathogen identification:

Polymerase chain reaction (PCR) amplification-based assay to test up to 45 pathogens

Therapeutic options:

  • Targeted detection of 38 resistance genes spanning 7 different antibiotic classes
  • Phenotypic data showcasing antibiotic sensitivity for polymicrobial environment
  • Personalized antibiotic options based on supportive evidence
interpretation

DETECTED PATHOGENS
Cells of organisms per milliliter of sample:

  • 10,000 – 49,999
  • 50,000 – 99,999
  • ≥100,000

Detection range as low as 500 cells/mL (depending on organism) to 6,000,000 cells/mL. Viral and STD pathogens will be noted as “detected” or “not detected” only.

ANTIBIOTIC RESISTANCE

  • Sensitive: antibiotic prevented growth of polymicrobial culture
  • Resistant: antibiotic did not prevent growth in polymicrobial culture
  • RGI: resistance gene identified
specimen

Urine

Voided urine or catheter urine collected within 5 days.

Samples that were frozen, have PreservCyt, or were collected with Foley catheter tips will be rejected.

Pathogen identification:

Polymerase chain reaction (PCR) amplification-based assay to test up to 45 pathogens

Therapeutic options:

  • Targeted detection of 38 resistance genes spanning 7 different antibiotic classes
  • Phenotypic data showcasing antibiotic sensitivity for polymicrobial environment
  • Personalized antibiotic options based on supportive evidence

DETECTED PATHOGENS
Cells of organisms per milliliter of sample:

  • 10,000 – 49,999
  • 50,000 – 99,999
  • ≥100,000

Detection range as low as 500 cells/mL (depending on organism) to 6,000,000 cells/mL. Viral and STD pathogens will be noted as “detected” or “not detected” only.

ANTIBIOTIC RESISTANCE

  • Sensitive: antibiotic prevented growth of polymicrobial culture
  • Resistant: antibiotic did not prevent growth in polymicrobial culture
  • RGI: resistance gene identified

Urine

Voided urine or catheter urine collected within 5 days.

Samples that were frozen, have PreservCyt, or were collected with Foley catheter tips will be rejected.

GUIDANCE reports deliver effective,
personalized therapy options
Click on the sample report to view in detail.

 

SAMPLE REPORT