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More informed treatment decisions
in less than one day

Precision diagnostic testing with rapid results for the management of complicated, recurrent or persistent UTIs and elevated risk patients

Organism
identification
(PCR)

27 individual organisms and 3 bacterial groups, developed using an evidence based analysis of uropathogens

Resistance
gene
detection
(PCR)

32 resistance genes and 6 different classes of antibiotics

Pooled
antibiotic
susceptibility
testing
(P-AST™)

Pooled Antibiotic Susceptibility Testing (P-AST) accounts for bacterial interactions that occur in polymicrobial infections that may alter antibiotic resistance

Delivers results in an easy to read report in less than one day from receipt at lab

Organism
identification
(PCR)

27 individual organisms and 3 bacterial groups, developed using an evidence based analysis of uropathogens

Resistance
gene
detection
(PCR)

32 resistance genes and 6 different classes of antibiotics

Pooled
antibiotic
susceptibility
testing
(P-AST™)

Pooled Antibiotic Susceptibility Testing (P-AST) accounts for bacterial interactions that occur in polymicrobial infections that may alter antibiotic resistance

Delivers results in an easy to read report in less than one day from receipt at lab

Guidance® UTI is an advanced test that better addresses polymicrobial infections in difficult cases, where bacterial interactions can impact antibiotic resistance.

Guidance® UTI provides personalized results in less than one day from receipt at lab, while culture can take 3-5 days, reducing the need for empiric therapy and supporting antibiotic stewardship initiatives.

Results are summarized in an easy- to-read report showing therapy options based on the patient’s individual infection.

Guidance® UTI uses PCR technology to identify commonly tested uropathogens, including fastidious bacteria, yeasts, and viruses that are difficult to detect by culture. Guidance UTI has demonstrated 95% sensitivity when identifying organisms, which is 43% more sensitive than culture.1 High sensitivity helps ensure accurate pathogen identification and UTI diagnosis.

Guidance® UTI identifies specific pathogenic organisms and effective treatments for polymicrobial infections, which have been shown to occur in up to 52% of positive cases.1 While culture may return these results as “contaminated” or “mixed flora”, Guidance UTI identifies the specific uropathogens in the specimen – even when multiple organisms are present.

Rather than relying on resistance gene information alone, Guidance® UTI provides personalized therapy options by using Pooled Antibiotic Susceptibility Testing (P-AST™), a unique technology that accounts for bacterial interactions that occur in polymicrobial infections that may alter antibiotic resistance.2

Real World Evidence

Guidance® UTI testing is associated with reductions in critical adverse outcomes, healthcare resource utilization and cost for complicated (cUTI).

Study size: for standard urine culture (N=678) or Guidance UTI® (N=69)

13%

lower rate of outpatient emergency visits

67%

lower inpatient admissions rate

NO

urosepsis, urgent care and skilled nursing facility admissions for every 1,000 patients in this study

$463.46

savings per cUTI patient tested with Guidance UTI (p=0.043)

42%

reduction in visits to emergency department, inpatient hospital, urgent care and SNF

$11.6 MIL
SAVINGS

for 25,000 cUTI cases

View a sample report

The Guidance® UTI report displays personalized therapy options to help speed the road to recovery.

With at-home kits, patients can collect samples for the Guidance® UTI test from the ease and comfort of home.

Many patients see telehealth as a safe and convenient alternative to office visits. Telehealth can facilitate access to care and reduce risk of exposure for both patients and providers. After the provider determines a patient is appropriate for Guidance® UTI testing, Pathnostics will send a Guidance® UTI collection kit directly to a patient’s home and arrange same-day pickup.

Telehealth Appointment
Provider determines patient has suspected UTI.

One step ordering
Healthcare provider faxes in the test order, and our team will take it from there.

Signature service
Pathnostics will call each patient to review specimen collection instructions, coordinate return, and answer questions about the process.

Fast turnaround time
Results reported in less than one day from receipt at lab for rapid directed treatment.

Frequently Asked Questions

In addition to the often-tested organisms Escherichia coli, Enterococcus faecalis, Klebsiella pneumoniae, and Staphylococcus aureus, we also test for an extremely comprehensive list of pathogens.

BACTERIAL/YEAST ORGANISMS:
  • Acinetobacter baumannii
  • Actinotignum schaalii
  • Aerococcus urinae
  • Alloscardovia omnicolens
  • Candida albicans
  • Candida auris
  • Candida glabrata
  • Candida parapsilosis
  • Citrobacter freundii
  • Citrobacter koseri
  • Corynebacterium riegelii
  • Enterococcus faecalis
  • Enterococcus faecium
  • Escherichia coli
  • Gardnerella vaginalis
  • Klebsiella oxytoca
  • Klebsiella pneumoniae
  • Morganella morganii
  • Mycoplasma hominis
  • Pantoea agglomerans
  • Proteus mirabilis
  • Providencia stuartii
  • Pseudomonas aeruginosa
  • Serratia marcescens
  • Staphylococcus aureus
  • Streptococcus agalactiae
  • Ureaplasma urealyticum
BACTERIAL GROUPS:
  • Coagulase-negative staphylococci*
  • Viridans group streptococci†
  • Enterobacter group‡
  • ESBL PHENOTYPE
    ESBL phenotypic assay will be performed when E. coli, Klebsiella, Enterocobacter, Citrobacter, Proteus, Acinetobacter, or Pseudomonas are detected
  • MRSA PHENOTYPE
    MRSA phenotypic assay will be performed when Staphylococcus aureus and the mecA gene are detected.

*Coagulase-negative staphylococci: Staphylococcus epidermidis, Staphylococcus haemolyticus, Staphylococcus lugdunenesis, Staphylococcus saprophyticus

Viridans group streptococci: Streptococcus anginosus,
Streptococcus oralis, Streptococcus pasteuranus

‡Enterobacter group: Klebsiella aerogenes (formally known as Enterobacter aerogenes), Enterobacter cloacae

Guidance® UTI has a large body of evidence, including three clinical studies with over 68,000 subjects and six peer-reviewed publications.

PEER-REVIEWED PUBLICATIONS

Key Findings and Clinical Implications

 

1. “Multiplex PCR Based Urinary Tract Infections (UTI) Analysis Compared to Traditional Urine Culture in Identifying Significant Pathogens in Symptomatic Patients”
  • PCR is 43% more sensitive than culture
  • M-PCR detected 93.4% of polymicrobial infections and culture only detected 22.3% of polymicrobial infections
  • Demonstrates that UTIs can be polymicrobial; culture is reported as “contaminated” if more than 2 organisms found

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2. “Multisite Prospective Comparison of Multiplex Polymerase Chain Reaction Testing with Urine Culture for Diagnosis of Urinary Tract Infections in Symptomatic Patient”
  • Demonstrates that M-PCR has a greater ability to detect bacteria than culture
  • M-PCR detected 95% of polymicrobial Infections and culture only detected 22% of polymicrobial infections
  • More than half of positive UTI cases (53%) involve polymicrobial infections
3. “Bacterial Interactions as Detected by Pooled Antibiotic Susceptibility Testing (P-AST) in Polymicrobial Urine Specimens”
  • Bacterial interactions in polymicrobial specimens can alter susceptibility
  • Standard Antibiotic Susceptibility fails to detect the interaction
  • Pooled Antibiotic Susceptibility Testing captures interactions and provides more effective therapy options
4. “Utilization of M-PCR and P-AST for Diagnosis and Management of Urinary Tract Infections in Home-Based Primary Care”
  • Guidance UTI is associated with a 13.7% reduction in hospital utllization
  • Earlier studies have shown that 16.7% of patients presenting to emergency department with a UTI are admitted to the hospital for further management
  • > 1/2 of hospitalized Medicare patients develop UTl-related bacteremic episodes that lead to prolonged hospital stays with higher healthcare costs, or death
5. “After 180 Years, Is it time for Something Better for Diagnosing UTls?”
  • Novel advanced diagnostic testing methods such as M-PCR coupled with P-AST can provide clinically relevant microbiological data missed by SUC
  • M-PCR is able to quickJy detect relevant uropathogens, especially Gram-positive bacteria, along with more polymicrobial infections in patients with UTI symptoms
  • M-PCR/P-AST results are associated with better outcomes
  • data can offer valuable clinical information for antibiotic stewardship
6. “Concordance Between the Presence of Antibiotic Resistance Genes and Antibiotic Susceptibility Test Results in Symptomatic Patients with Urinary Tract Infection”
  • Overall, there was 60% concordance between presence/absence of ABR genes and pooled susceptlbility, while 40% of the time the data did not agree.
  • PCR alone to detect antibiotic resistance genes did not provide sufficient data in 40% of cases analyzed to make informed clinical decisions in UTI management.
  • However, when used in conjunction with P-AST. ABR gene data can offer valuable clinical information for antibiotic stewardship.

We leverage a dual assessment—genotype resistance and Pooled Antibiotic Susceptibility Testing (P-AST)—to uncover more effective, personalized therapy options.

Pooled Antibiotic Susceptibility Testing (P-AST) includes:
  • Ampicillin (PO/IV)
  • Ampicillin/Sulbactam (IV)
  • Amoxicillin/Clavulanate (PO)
  • Cefaclor (PO)
  • Cefazolin (IV)
  • Cefepime (IV)
  • Cefoxitin (IV)
  • Ceftazidime (IV)
  • Ceftriaxone (IM/IV)
  • Ciprofloxacin (PO/IV)
Genotype antibiotic resistance genes include:
  • Ampicillin
  • Carbapenem
  • Extended Spectrum Beta-Lactamase
  • Methicillin
  • Quinolinone/Fluoroquinolone
  • Vancomycin
  • Fosfomycin (PO/IV)
  • Gentamicin (IM/IV)
  • Levofloxacin (PO)
  • Meropenem (IV)
  • Nitrofurantoin (PO)
  • Piperacillin/Tazobactam (IV)
  • Sulfamethoxazole/Trimethoprim (PO/IV)
  • Tetracycline (PO)
  • Vancomycin (IV)
KEY
  • Guidance® UTI

Pathnostics’ GUIDANCE® UTI Test utilizes PCR amplification for the targeted detection of agents. Pathogens are reported in ranges of organism(s) per milliliter of urine.

P-AST better reflects the infection’s actual resistance in the body.

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References:
1. Vollstedt A, Baunoch D, Wojno KJ, Luke N, Cline K, et al. (2020). Multisite Prospective Comparison of Multiplex Polymerase Chain Reaction Testing with Urine Culture for Diagnosis of Urinary Tract Infections in Symptomatic Patients. J Sur urology, JSU-102. DOI: 10.29011/ JSU-102.100002
2. Vollstedt A, Baunoch D, Wolfe A, Luke N, Wojno KJ, et al. (2020). Bacterial Interactions as Detected by Pooled Antibiotic Susceptibility Testing (P-AST) in Polymicrobial Urine Specimens. J Sur urology, JSU-101. DOI: 10.29011/JSU-101.100001
3. Vos MG de, Zagorski M, McNally A, Bollenbach T (2017) Interaction networks, ecological stability, and collective antibiotic tolerance in polymicrobial infections. Proceedings of the National Academy of Sciences 114:10666–10671. https://doi.org/10.1073/pnas.1713372114
† When specimen collected as instructed

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