GenePOC obtains FDA clearance for its GenePOC(TM) Carba test in the US

Québec, Canada (ots) - GenePOC announces FDA clearance of its
molecular diagnostic test for the detection and differentiation of
the five most frequent gene sequences associated with
carbapenem-non-susceptibility.

GenePOC Inc., member of the Debiopharm, announces the clearance by
the FDA of its fourth test in the US, the GenePOC Carba assay, to be
used with the revogene(TM) device.

About carbapenem-producing organisms (CPO)

CPO are known to be resistant to commonly used antibiotics and
occasionally completely resistant to all available antibiotics. They
are considered a serious global public health threat and are
associated with significant morbidity, mortality and hospital
costs[1]. In USA, the Centers for Disease Control and Prevention
(CDC) recommends strong infection control measures for patients who
are colonized or infected with CPO[2].

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 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

It is important to note that 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[3].

"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

About revogene

The revogene is an automated and stand-alone device, enabling
testing of single-use proprietary microfluidic cartridges with
fluorescence-based real-time PCR technology to deliver an accurate
diagnosis.

About GenePOC

GenePOC, member of Debiopharm Group, develops diagnostic devices
which enable the prevention and detection of infectious diseases.
Further information: www.genepoc-diagnostics.com

About Debiopharm

Debiopharm aims to develop innovative therapies that target high
unmet medical needs in oncology and bacterial infections by bridging
the gap between disruptive discovery products and real-world patient
reach. Further information: www.debiopharm.com.

[1: Borer A., Infect Control Hosp Epidemiol. 2009]
[2: Global Spread of Carbapenemaseproducing Enterobacteriaceae.
Emerging Infectious Diseases - www.cdc.gov/eid - Vol. 17, No. 10,
October 2011: http://ots.ch/xqPA0n]
[3: http://ots.ch/serODd]

Pressekontakt:
Patrice Allibert, CEO
patrice.allibert@genepoc.ca
Tel: +1-418-650-3535

Original-Content von: Debiopharm International SA, übermittelt durch news aktuell