A LONG-TERM UTI SOLUTION F O R H E A LT H I E R PAT I E N T S I N YO U R LO N G -T E R M C A R E

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GUIDANCE

By resolving UTIs faster and keeping patients comfortably in your care, you can avoid possible extra costs such as ambulance services, hospitalization, and loss of bed-hold payments.

GUIDANCE24-48 HOURS UP TO 5 DAYS

URINE CULTURE

W A I T F O R R E S U L T S

QUICK AND EFFECTIVE RESOLUTION OF URINARY TRACT INFECTIONS TAKES GUIDANCE

In long-term care, UTIs are a major cause of unnecessary spending and declining patient health. But a solution is easier than you might expect.

Guidance is a rapid molecular test for pathogen identification and antibiotic sensitivity (Patent Pending) determination. Simply put, it means you can test for common UTIs in a fraction of the time of standard urine culture and with higher accuracy. That can result in improved outcomes for both your patients and the financial health of your organization.

VS

TECHNICAL DETAILS

• Guidance detects presence of microbial DNA from pathogens that can cause UTIs

• Provides antibiotic treatment recommendations

• Detected pathogens are reported as “Detected,” “>10,000,” “>50,000,” or “>100,000 cells of organism(s) per milliliter of urine”

• Antibiotic Resistance (ABR) listed as either “Sensitive” or “Resistant”

• Voided urine or catheter urine

• Rejection Criteria: >3 days of collection time, frozen, samples collected in PreservCyt, or Foley catheter tips

CLINICAL UTILITY INTERPRETATION SPECIMEN

PATHOGEN IDENTIFICATION Polymerase chain reaction

(PCR) amplification-based assay

DETECTION RANGEAs low as 500 cells/mL (depending on organism) to 6,000,000 cells/mL

TEST METHODOLOGY

THERAPEUTIC OPTIONS Antibiotic sensitivity of the collection of pathogens along with detection

of antibiotic-resistant genes

HEALTHY PATIENTS = HEALTHY FINANCIALS

Efficient and accurate UTI diagnosis with Guidance can help keep your

patients in their scheduled physical or occupational therapy in your facility.

That can help you avoid a downgrade in the assigned Medicare level and

diminished reimbursement.

Providing better quality patient care can also positively affect your

star rating and quality data.

SEE WHY GUIDANCE IS SUPERIOR TO STANDARD CULTURE

Relying on urine culture to diagnose UTIs has significant shortcomings. By leveraging a novel molecular and antibiotic sensitivity test, Guidance provides more robust solutions for better outcomes for both your patients and your organization’s bottom line.

MISSED DIAGNOSISStandard urine culture misses up to 2/3 of all UTI-positive patients.1

GUIDANCE demonstrates a 26% increase in sensitivity.2

GUIDANCE URINE CULTURE

Number Misdiagnosed 7 142

Percentage Misdiagnosed 4% 69%

GUIDANCE improves diagnostic accuracy by more than 65%.2

POLYMICROBIAL INFECTIONSIn the elderly population, the mortality rate for those patients with symptomatic UTIs is as high as 33%.3 And the rate of polymicrobial UTIs is as high as 39%.4

GUIDANCE detects 61% more organisms than culture. (actual exposure of patient specimen to antibiotic).2

GUIDANCE URINE CULTURE

Number Detected 423 159

Percentage Detected 97% 36%

GUIDANCE URINE CULTURE

Positive Cases 200 148

Percentage Sensitivity 97% 71%

SLOW GROWING PATHOGENSUrine 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).

1. Price TK, Dune T, Hilt EE, Thomas-White KJ, Kliethermes S, Brincat C, Brubaker L, Wolfe AJ, Mueller ER, Schreckenberger PC. The clinical urine culture: enhanced techniques improve detection of clinically relevant microorganisms. Journal of Clinical Microbiology. 2016 May;54(5):1216-22.

2. Data based on Pathnostics Laboratory internal studies comparing 300 cases of traditional urine culture vs. Guidance.

3. Cove-Smith A, Almond MK. Management of urinary tract infections in the elderly. Trends in Urology, Gynaecology & Sexual Health. 2007 Jul;12(4):31-4.

4. Laudisio A, Marinosci F, Fontana D, Gemma A, Zizzo A, Coppola A, Rodano L, Incalzi RA. The burden of comorbidity is associated with symptomatic polymicrobial urinary tract infection among institutionalized elderly. Aging Clinical and Experimental Research. 2015 Dec;27(6):805-12.

1CHALLENGE

2CHALLENGE

3CHALLENGE

ORGANISM(S) DETECTED

ANTIBIOTICS WITH DEMONSTRATED SENSITIVITY

Gentam

icin

Mero

penem

Trimetho

prim

/S

ulfamethoxazo

le

Beta-L

actamase

Inhibito

r C

om

binatio

ns

Cep

halosp

orins

Fluo

roq

uinolo

nes

Am

inop

enicillins

Nirro

furans

Gentam

icin

Mero

penem

Trimetho

prim

/S

ulfamethoxazo

le

Am

oxicillin/ C

lavulante

Am

picillin/

Sulb

actam

Pip

eracillin/Tazo

bactam

Ceftriaxo

ne

Ceftazid

ime

Cip

rofloxacin

Am

picillin

Nitro

frantoin

Formulations IM/IV IV PO/IV PO IV PO/IV IM/IV IV PO/IV PO/IV PO

Pooled Phenotype Sensitivity S S S S S S S S S S S

MIC Results (ug/ml) 40 10 20 80 40 40 40 40 160 80 320

Pooled Resistence Gene(s) Identified RGI

Escherichia coli > 100,000 cells/mL

Enterococcus faecalis > 50,000 cells/mL

Streptococcus anginosus > 10,000 cells/mL

Antibiotic Resistance Genes Detected:

Quinolinone/FluoroquinoloneVancomycin

Other Non-Bacterial Pathogens Detected:

Candida albicans > 10,000 cells/mL

Antibiotic Resistance Detected:

Celfaclor (PO)Cefazolin (IV)Cefoxitin (IV)Cefepime (IV)

Levofloxacin (PO/IV)Tetracycline (PO)Vancomycin (IV)

= Supportive Evidence

S = Sensitive

RGI = Resistance Gene Identified

43 organisms tested, see second page for those not detected

GUIDANCE RESULTS DELIVER EFFECTIVE, PERSONALIZED TREATMENT OPTIONS

Lack Supportive Evidence Because:

Intrinsic resistance is common

Limited anecdotal or clinical data to support effectiveness

Other antibiotics more effective

Even though agents are found sensitive in vitro, they are ineffective clinically

MIC (Minimum Inhibitory Concentration) results provide the concentration (ug/mL) of antibiotic the bacteria would be considered sensitive

Class of antibiotics withdemonstrated sensitivity

Antibiotics and formulationswith demonstrated sensitivity

Highlighted/bold boxes indicate situations where:• organism(s) detected in patient specimen are sensitive to antibiotic• targeted resistance gene for that antibiotic NOT detected• antibiotic has supportive evidence for all organisms detected in patient specimen

Drug resistance detected based on phenotype testing (actual exposure of patient specimen to antibiotic)

Antibiotic resistance genes detected based on genotype testing (identification of pathogen DNA within pool of DNA isolated from detected organisms)

Other non-bacterial pathogens (fungus, STDs, virus, etc.) detected

PARTNER WITH PATHNOSTICS TO HELP PROVIDE SUPERIOR, COST-EFFECTIVE CARE

• Full range of Guidance service offerings

• Easy integration into your existing EHR system

• Proven track record of success

Pathnostics is dedicated to providing the highest level of customer service and convenience. We look forward to earning your trust as a reliable partner for high quality, cost-effective UTI diagnostic lab services.

ACCESS FOR YOUR PATIENTS

• Covered by Medicare

• Proven and comprehensive financial assistance for patients

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Guidance was developed and its performance characteristics determined by Pathnostics. © 2018 Pathnostics. All rights reserved.