Technology Bundle ID: TAB-3218

Real-Time PCR Assay for Detection of Carbapenem Antibiotic Resistance Genes of the IMP-type

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Licensing Contact:
Primary Inventors: 
Linda Karlsson (CDC)
Co-Inventors: 
Davina Campbell (CDC)
Development Stage: 
Pre-Clinical (in vitro)
Institute or Center: 
CDC

Antibiotic resistance is one of the world's most pressing health concerns. β-lactamases, such as carbapenemases, are enzymes produced by bacteria that provide resistance to multiple β-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.

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
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

Patents

PCT Application PCT/US2018/037395
Filed on 2018-06-13
US Application 16/615,725
Filed on 2019-12-05
US Application 62/519,663
Filed on 2017-06-14

Updated

Dec 4, 2017

Data Source: 
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