PhenoPathway™ Rapid Phenotypic Susceptibility Testing

Direct from positive urine qPCR results

Promus Diagnostics, LLC is an in vitro diagnostics company dedicated to providing solutions for the widespread challenge of Antibiotic Resistance and Infectious Disease. We deliver clinical laboratory services that better enable physicians, clinics and hospitals to fulfill their antibiotic stewardship responsibilities while improving patient outcomes.

The Need

The Centers for Disease Control and Prevention estimate at least 2 million people each year are infected with antibiotic resistant bacteria across the U.S. In addition, antibiotic resistance contributes to the morbidity and mortality of healthcare-associated infections (HAI) that kill an estimated 75,000 people annually.1

Early diagnosis of antibiotic resistant bacteria is critical to providing patients optimal therapy. The only way to know which therapy will work is to test a range of antibiotics. Typical, conventional antibiotic susceptibility testing requires time consuming manual procedures, resulting in laboratory processing time that often exceeds 48 hours, leaving clinicians with incomplete information to provide definitive treatment during this critical time period.

The Solution

Using the PhenoPathway™ system with positive qPCR test results, Promus Diagnostics can substantially reduce the processing time by testing directly from positive urine samples, which enables clinicians to provide patients optimal therapy up to 40 hours faster than conventional methods.

The Promus PhenoPathway is capable of simultaneous detection and identification of multiple microbial targets followed by susceptibility testing of appropriate detected bacterial organisms using Flow Cytometry of microbial cells and colonies coupled with antibiotics. Results are intended to be interpreted in conjunction with qPCR Gram stain results.

Promus Pathway provides fast actionable answers clinicians need to personalize antibiotic therapy for patients up to 2 days faster than standard urine culture methods. Faster identification and antibiotic susceptibility results coupled with antibiotic stewardship are directly linked to improved outcomes and decreased cost.² MIC-based antibiotic susceptibility testing can rule out therapy due to resistance and  also rule out antibiotic options that report as susceptible.

MIC results provided through phenotypic susceptibility testing offers additional value when compared with qPCR genotype resistance marker testing.

Presumptive genotype results offer early indications of potentially resistant infections. While certain gene based results may drive decisions to escalate therapy, clinicians often choose to wait for phenotypic susceptibility results before modifying antibiotic treatment.

The MIC results can provide exact information to determine which antibiotic is the most targeted and effective in each individual patient’s clinical situation. The MIC enables the clinician to calculate the specific dosage that will maintain antibiotic efficacy throughout treatment, allowing for individualized patient therapy.

The absence of a resistance gene does not always guarantee susceptibility to a class of antibiotics

The presence of a resistance gene does not always correlate with phenotypic resistance testing

Resistance markers have limited ability to guide individualized therapy for patients

  • Decreases time to effective therapy

  • Optimize therapy specific to patient

  • Improve patient outcomes

  • Decrease Antimicrobial Resistance

  • Lowers cost of treatment

  • Meaningful antibiotic stewardship

References:

  1. Reports from the Centers for Disease Control and Prevention found cdc.gov/hai/surveillance/ and cdc.gov/drugresistance/
  2. Huang AM, Clin Infect Dis. 2013 Nov; 57(9): 1237-45; Perez KK, J Infect. 2014 Sep; 69(3): 216-25