GenePOC Launches its GenePOC(TM) CDiff test in the United States / GenePOC announces the launch and FDA clearance of its Clostridium difficile molecular test in US

Québec, Canada (ots) - GenePOC Inc. (GenePOC), a member of the
Debiopharm Group(TM), is proud to announce the launch of its 2nd FDA
cleared assay in less than 6 months, GenePOC(TM) CDiff, for use on
the revogene(TM) instrument. The GenePOC CDiff test targets the toxin
B gene of toxigenic C. difficile strains in unformed stool specimens
obtained from patients suspected of having C. difficile infection
(CDI). The test provides a novel and highly flexible alternative to
assist clinicians in rapidly identifying, isolating and treating
patients having CDI. Consequently, rapid management of patients
having CDI will aid in preventing the spread of the bacteria -
identified as an urgent threat in healthcare settings by the center
for disease control (CDC).

About C. difficile infection in the US

In the United States, CDI is the leading cause of infectious
antibiotic-associated diarrhea with 293 000 infections per year(1)
representing $4.8 billion in additional healthcare cost per year(2).
CDI poses many challenges to health institutions, among which is
being able to efficiently test the patients at risk.

Traditional testing methods for identification of toxigenic C.
difficile, such as toxigenic culture and enzyme immunoassays (EIA),
have been found to be labor intensive, to increase delays and, to
have limited sensitivity(3).

There exists a need for a faster and simpler testing algorithm.
According to the 2010 guidance from the American Society for
Microbiology, nucleic acid amplification tests detecting C. difficile
toxin genes may be used as a stand-alone test(4). In fact, those
molecular tests provide sensitive, specific and timely identification
of patients with toxigenic C. difficile infection, and exhibit better
performance than toxin EIAs(5).

According to Dr Nathan Ledeboer from the Medical College of
Wisconsin, in Milwaukee: "It all starts with timely diagnosis of C.
difficile infections to critically impact patient management and
ensure proper implementation of infection control practices". Dr
Nathan Ledeboer participated in a multicentric clinical trial,
evaluating GenePOC CDiff test for use on the revogene instrument.

About GenePOC CDiff test

The GenePOC CDiff assay is a qualitative in vitro diagnostic test
to detect the toxin B (tcdB) gene of toxigenic C. difficile in
unformed (liquid or soft) stool specimens obtained from patients
suspected of having CDI. Performing this test enables healthcare
professionals to detect the presence of toxigenic C. difficile within
70 minutes after loading the patient sample in the test cartridge or
PIE. Early and accurate detection can lead to better control and
management of CDI, which in turn can improve patient management and
reduce the risk of transmission.

"A simple one-step algorithm to detect toxigenic C. difficile,
using a clinical test with excellent performance, will inevitably
contribute to better control the spread of CDI and reduce outbreaks"
says Dr Patrice Allibert, CEO of GenePOC. "What makes our assay so
unique is its right balance between sensitivity and specificity. This
translates into the ability to identify patients with CDI from a
single GenePOC CDiff test, a molecular test with less than 1%
unresolved rate according to clinical trial results. Our test is
performed on the affordable, user-friendly revogene instrument which
can be directly connected to the hospital and laboratory information
systems (LIS/HIS), for seamless transmission and communication of
actionable results", Patrice Allibert continued.

About revogene(TM)

The revogene is an automated and stand-alone instrument. It
enables testing of single-use proprietary microfluidic cartridges,
called PIEs, with fluorescence-based real-time polymerase chain
reaction platform to deliver an accurate diagnosis. revogene, has
been award winning for its innovative technology and design(6),(7).

The revogene instrument is both CE-Marked and FDA cleared.

About GenePOC

GenePOC is a company that specializes in the development of
diagnostic devices which enable the prevention and detection of
infectious diseases. The company aims to become the market leader in
the rapid microbial testing at the point of care (POC). GenePOC is a
member of the Debiopharm Group. GenePOC's revogene instrument is
available in the US and EU markets with a rapidly expanding test
menu. Further information: www.genepoc-diagnostics.com

About Debiopharm Group

Debiopharm Group(TM) is a Swiss-headquartered global
biopharmaceutical group including five companies active in the life
science areas of drug development, GMP manufacturing of proprietary
drugs, diagnostic tools and investment management. For more
information, please see www.debiopharm.com

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(1) References Dubberke et al. Clin Infect Dis 2012; 55: S88-92.
(2) Lessa et al. N Engl J Med 2015; 372(9):825-834.
(3) Carroll KC. Tests for the diagnosis of Clostridium difficile
infection: the next generation Anaerobe. 2011 Aug;17(4):170-4.
(4) Cohen SH, Gerding DN, Johnson S, et al. Clinical practice
guidelines for Clostridium difficile infection in adults: 2010
update by the Society for Healthcare Epidemiology of America
(SHEA) and the Infectious Diseases Society of America (IDSA).
Infect Control Hosp Epidemiol 2010; 31:431-55.
(5) Wilcox MH, Planche T, Fang FC. What is the current role of
algorithmic approaches for diagnosis of Clostridium difficile
infection? J Clin Microbiol, 2010, vol. 48 (pg. 4347-4353).
(6) 2017 Best of the Best RedDot Award, 2017
(7) Frost & Sullivan European Molecular Diagnostics for
Infectious Disease New Product Innovation Award, 2017

Pressekontakt:
Contact at Debiopharm International SA
Christelle von Büren
Communications Coordinator
christelle.vonburen@debiopharm.com
Tel.: +41 (0)21 321 01 11

Contact at GenePOC
Patrice Allibert, Ph.D
CEO
patrice.allibert@genepoc.ca
Tel.: +1-418-650-3535

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