GenePOC announces FDA clearance for revogene(TM) instrument and its GBS LB test

Québec, Canada and Lausanne, Switzerland (ots) - GenePOC announces
it received 510(k) clearance from the US Food and Drug Administration
to market its first molecular assay to detect Group B Streptococcus
and for the revogene molecular diagnostics instrument.

GenePOC, Inc. (GenePOC) a member of the Debiopharm Group is
pleased to announce that it has received FDA clearance for its
GenePOC(TM) GBS LB assay and its revogene(TM) instrument. GenePOC
considers this system as the most cost effective diagnostics solution
in the molecular point of care market today. This is a key
accomplishment in the evolution of GenePOC's commercial operations.
This validation of revogene and GBS LB test will allow access to the
US market, after its successful introduction in Europe in Q1 2017.

"The GenePOC GBS LB test will fulfill the increasing market need
for cost-effective automated and easy-to-use testing for the
identification of antepartum Group B Streptococcus colonization. This
will lead to better control of the risk of transmission and infection
of the newborn, potentially lowering mortality and morbidity",
Patrice Allibert CEO of GenePOC commented. "The achievement of 510k
clearance is a milestone for GenePOC, and the result of a collective
team effort, giving us high confidence as we work towards our second
assay submission to the FDA for the detection of Clostridium
difficile in the near future", he continued.

"Our laboratory participated in the clinical validation of GenePOC
group B Streptococcus assay. This was a parallel study which compared
the GenePOC assay to the standard culture. The assay used vaginal and
rectal swabs from pregnant women enriched in LIM broth for 18-24
hours prior to testing. GenePOC had high sensitivity and specificity
during validation studies and clinical trials. The system was easy to
use and provided the results up to 18 hours faster than standard
culture", Dr Hossein Salimnia, Professor of Pathology and Chief of
Microbiology Division, Wayne State University School of Medicine and
Detroit Medical Center University Laboratories, Detroit commented.

About revogene instrument

The revogene is a compact, fully automated stand-alone instrument
well suited to on the spot molecular diagnostic testing. The revogene
offers unique flexibility, allowing the labs to run from 1 to 8
samples simultaneously, for an optimal testing workflow. Its
user-friendly and innovative design has been recognized by the Red
Dot with the best of the best 2017 award.

About GBS testing

Group B Streptococcus (GBS) remains the most common cause of
neonatal sepsis and meningitis in the world1. The CDC recommends
universal antepartum screening for GBS vaginal and rectal
colonization for all woman at 35-37 weeks of gestation, along with
intrapartum antibiotic prophylaxis2,3. While this has resulted in a
decrease in early onset disease (EOD) rate, there is still an ongoing
need for more precise GBS detection.

GenePOC GBS LB assay detects GBS colonization from Lim Broth
samples using the real-time Polymerase Chain Reaction (PCR)
technology. In clinical performances studies, the overall sensitivity
and specificity of GenePOC GBS LB were 95,9% and 95,5% respectively,
compared with standard culture.

About GenePOC

GenePOC is a company that specializes in the development of
diagnostic devices which enable the prevention and detection of
infectious diseases. A member of the Debiopharm Group, the company
aims to become the market leader in the rapid microbial testing at
the point of care (POC). GenePOC's revogene(TM) instrument is
available on the market also in Europe and the Middle East 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

We are on Twitter. Follow @DebiopharmNews at
http://twitter.com/DebiopharmNews

REFERENCES

1. Simonsen et al. (2014) Early-onset neonatal sepsis. Clinical
microbiology reviews 27.1 pp 21-47.

2. CDC. (2010). Prevention of Perinatal Group B Streptococcal
Disease, Revised Guidelines. Morbidity and Mortality Weekly Report,
Vol.59.

3. ACOG, A.C. (2011). Prevention of Early-Onset Group B
Streptococcal Disease in Newborns. Committee Opinion, 1.2

Pressekontakt:
Contact at Debiopharm Group
Christelle Tur
Communications Coordinator
christelle.tur@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