GenePOC Obtains CE Marked for Its GenePOC™ Carba Test
QUEBEC CITY, April 11, 2019 /PRNewswire/ -- GenePOC Inc., member of the Debiopharm Group, announces its third test to be CE marked, the GenePOC Carba assay, to be used with the revogene™ device.
About carbapenem-producing organisms (CPO)
CPO are considered a serious global public health threat and are associated with significant morbidity, mortality and hospital costs.1 In 2015, 13 of the 38 countries of the European Union and European Economic Area (EU-EEA) reported interregional spread or an endemic situation.2 High mortality rates, ranging from 30% to 75%, have been reported for patients with severe CPO infections.3
About the GenePOC Carba assay
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 isolated colonies of Enterobacteriaceae, Acinetobacter baumannii, or Pseudomonas aeruginosa.
"The fight against carbapenemase-producing Enterobacteriaceae (CPE), a rising threat in healthcare facilities, requires rapid and efficient detection and differentiation," mentioned Professor Thierry Naas, MD, from the bacteriology services at Hôpital de Bicêtre, France.
It is important to note that CPO are adapted to spread in healthcare settings as well as in the community. To prevent transmission from CPO-positive patients, hospitals should consider enhanced infection control measures such as contact precautions, isolation and dedicated nurses for patients who are confirmed CPO-positive.2
"We are proud to receive the CE marked for our GenePOC Carba assay," said Patrice Allibert, PhD, CEO of GenePOC. "A test which offers rapid and accurate results will contribute to the identification of colonized patients, therefore limit the spread of these organisms in healthcare settings and save on hospital costs. Our GenePOC Carba assay also demonstrates the power of our technology to be compatible with panel detection," concluded Patrice Allibert.
The revogene is an automated and stand-alone device, enabling testing of single-use proprietary microfluidic cartridges with fluorescence-based real-time polymerase chain reaction technology to deliver an accurate diagnosis.
GenePOC, a member of the Debiopharm group, specializes in the development of diagnostic devices which enable the prevention and detection of infectious diseases.
Further information: www.genepoc-diagnostics.com
About Debiopharm Group
Debiopharm Group is a global biopharmaceutical group including five companies active in life sciences. Further information: www.debiopharm.com.
1. Borer A et al. Infect Control Hosp Epidemiol. 2009;30(10) :972-6
3. Tischendorf J. et al. Am J Infect Control. Epub 2016 Feb 15.
Contact at GenePOC
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