GenePOC obtains CE marking for its GenePOC ™ Carba test



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QUÉBEC, April 11, 2019 / PRNewswire / – GenePOC Inc., a member of the Debiopharm Group, announces that its third test bearing the CE Mark, the GenePOC Carba Test, will be used with the revogene ™ device.

About Carbapenem Producing Organizations (CPOs)

OACs are considered a serious threat to public health worldwide and are badociated with significant morbidity, mortality and hospital costs.1 In 2015, 13 of the 38 countries in the European Union and the European Economic Area (EEA-EEA) reported an interregional spread or an endemic situation.2 High mortality rates, ranging from 30% to 75%, have been reported in patients with severe PCO infection.3

About the GenePOC Carba test

The GenePOC Carba test is a qualitative, in vitro diagnostic test designed for the detection and differentiation of blahKPC, blahNDM, blahVIM blahOXA-48-like, and blahIMP gene sequences badociated with carbapenem non-susceptibility. The test can provide results on up to eight samples in approximately 70 minutes using isolated non-sensitive characterized carbapenem colonies. Enterobacteriaceae, Acinetobacter baumannii, or Pseudomonas aeruginosa.

"The fight against carbapenemase-producing Enterobacteriaceae (CPE), a growing threat in health facilities, requires rapid and effective detection and differentiation" Thierry Naas, MD, Bacteriology Services, Bicêtre Hospital, France.

It is important to note that OPCs are suitable for spread in health facilities as well as in the community. To prevent transmission by CPO-positive patients, hospitals should consider strengthening infection control measures, such as contact precautions, isolation, and dedicated nurses for patients whose CPO confirmation is positive .2

"We are proud to receive CE marking for our GenePOC Carba "said Patrice Allibert, PhD, CEO of GenePOC. "A test with fast and accurate results will help identify colonized patients, limit the spread of these organisms in health care facilities and reduce hospitalization costs." Our GenePOC Carba test also demonstrates that Power of our technology is compatible with the panel. concluded Patrice Allibert.

About revogene

The revogene is an autonomous, stand-alone device for testing proprietary microfluidic single-use cartridges with real-time fluorescence-based chain reaction technology to achieve accurate diagnosis.

About GenePOC

GenePOC, a member of the Debiopharm Group, specializes in the development of diagnostic devices for the prevention and detection of infectious diseases.

Further information: www.genepoc-diagnostics.com

About the Debiopharm Group

The Debiopharm Group is a global biopharmaceutical group of five life science companies. Further information: www.debiopharm.com.

1. Borer A and al. Infect Control Hosp Epidemiol. 2009; 30 (10): 972-6
2. https://ecdc.europa.eu/sites/portal/files/media/en/publications/Publications/carbapenem-resistant-enterobacteriaceae-risk-badessment-april-2016.pdf
3. Tischendorf J. et al. Am J Infect Control. Epub 2016 February 15th.

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