FDA Clearance for GenePOC™ Carba Test in the US
GenePOC Inc has received FDA clearance for its fourth test in the US, the GenePOC Carba assay, to be used with the revogene™ device.
The GenePOC Carba assay is a qualitative, in vitro diagnostic test designed for the detection and differentiation of the blaKPC, blaNDM, blaVIM, blaOXA-48-like, and blaIMP gene sequences associated with carbapenem-non-susceptibility. The assay can provide results from one up to eight samples in approximately 70 minutes using characterized carbapenem-non-susceptible pure colonies of Enterobacteriaceae, Acinetobacter baumannii, or Pseudomonas aeruginosa.
“There is an increasing number of CPO outbreaks which are difficult to control and overlap with spread to and within the community. The current diversity of carbapenemases that may be identified in a given geographical region underlines the need to possess methods that will identify a large spectrum of carbapenemases.’’ - Patrice Nordmann, Head of the Molecular Microbiology at the University of Fribourg, Switzerland.
“The FDA clearance for the GenePOC Carba assay represents a key milestone for GenePOC and shows how our technology is a key differentiator in the rapid diagnostics market. The flexibility of the technology will enable us to adapt to the constant evolution of this public threat by integrating more additional genes or subtypes as needed’’ - Patrice Allibert, CEO of GenePOC
Date Published: 20th May 2019
Source article link: GenePOC Inc.
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