Technology ID
              TAB-3218
          Real-Time PCR Assay for Detection of Carbapenem Antibiotic Resistance Genes of the IMP-type
E-Numbers
          E-156-2017-0
              Lead Inventor
          Karlsson, Linda
              Lead IC
          CDC
              Co-Inventors
          Campbell, Davina
              ICs
          CDC
              Applications
          Therapeutics
          Research Materials
          Occupational Safety and Health
          Diagnostics
          Consumer Products
              Therapeutic Areas
          Infectious Disease
              Development Stages
          Pre-Clinical (in vitro)
              Antibiotic resistance is one of the world's most pressing health concerns. ß-lactamases, such as carbapenemases, are enzymes produced by bacteria that provide resistance to multiple ß-lactam antibiotics (e.g., penicillins, cephamycins, and carbapenems) by breaking down the antibiotic molecules and deactivating their antibacterial properties. Carbapenems are broad-spectrum antibiotics often prescribed to treat serious infections in hospitalized patients, and infections with carbapenem-resistant Enterobacteriaceae (CRE) have become a challenge in healthcare settings. 
Clinical laboratories frequently use phenotypic tests to screen for carbapenemase-producing isolates. However, these phenotypic tests can be difficult to interpret and are unable to identify specific resistance genes. PCR can be utilized to detect the presence of specific resistance genes, such as IMP, and produces rapid results that are easily interpretable.  
To date, the only FDA-approved and commercially available test for carbapenemase gene screening is restricted to a subset of all IMP genes (IMP-1 subgroup). CDC has developed a primer and probe-based real-time PCR assay with the capacity to detect carbapenemase genes of all currently described IMP variants. CDC's assay has successfully detected IMP genes in multiple bacterial isolates submitted to CDC in cases where the state or public health lab was unable to do so. This assay is easy to perform and implement, and offers a more cost- effective approach than whole genome sequencing.
      
  Commercial Applications
              - Real-time PCR diagnostic assay for detection of IMP genes important in carbapenem antibiotic resistance and in patients with serious infections in healthcare settings
 - Monitoring and public health surveillance for antimicrobial resistance
 
Competitive Advantages
              - Can be used to identify all known IMP variants in carbapenem-resistant bacteria versus currently available tests that can only detect limited IMP sub-groups
 - More cost effective than whole genome sequencing for detecting IMP-variants
 - Easy to perform and implement; results are easy to interpret
 - Assay protocol will be shared with Antimicrobial Resistance Laboratory Network of 7 regional and 55 state and public health laboratories
 
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