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Medical Devices / Submissions and Approvals

GenePOC CE Marked for CPO Diagnostic Test

April 12, 2019

Canadian diagnostic maker GenePOC received the CE Mark for its Carba assay, an in vitro test for carbapenemase-producing organisms (CPO) that can cause serious infections that are resistant to many antibiotics.

The assay can produce results from one to eight samples in approximately 70 minutes using isolated colonies of enterobacteriaceae, Acinetobacter baumannii, or Pseudomonas aeruginosa bacteria.  

The organisms are commonly found in many countries and are linked to significant mortality, morbidity and hospital costs.

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