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

Québec, Canada (ots) - GenePOC Inc., member of the Debiopharm
Group, announces its third test to be cleared by the FDA, the GenePOC
Strep A assay, to be used with the revogene(TM) device.

About Group A Streptococcus (GAS) infection

GAS is the most common bacterial etiology of pharyngitis
accounting for 15 to 30% cases in children and 5 to 20% in adults[1].
In the United States, approximately 11 to 13 thousand cases of
invasive GAS disease occur each year[2].

About the GenePOC Strep A assay

The GenePOC Strep A assay is a qualitative in vitro diagnostic
test for the detection of Streptococcus pyogenes nucleic acids from
throat swab specimens obtained from patients with signs and symptoms
of pharyngitis. The assay can provide results as early as 42 minutes
for positive specimens and in approximately 70 minutes for negative
specimens, without the need for culture confirmation.

"The GenePOC Strep A assay demonstrated good performance during
our evaluation and is a promising alternative to throat cultures and
Rapid Antigen Diagnostic Tests (RADT)." - Amanda Harrington, Medical
Director of Microbiology at the Loyola University in Chicago.

It is important to note that about 11 million patients in the US
are diagnosed with pharyngitis in the emergency room[3]. More
importantly, over 70% of pharyngitis have a viral cause[4]. A test
completed within an hour can allow physicians to better manage
patients.

"The GenePOC Strep A assay can provide "actionable" results
without the need to confirm by culture. GenePOC is committed to
developing important assays to complete its current offering,
becoming a strong player in the field of rapid molecular
diagnostics". - Patrice Allibert, CEO of GenePOC

About revogene

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.

About GenePOC

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: Bisno AL et al. Clin Infect Dis. 2002 Jul 15;35(2):113-125]
[2: Centers for Disease Control and Prevention (CDC)
www.cdc.gov/groupastrep/surveillance.html]
[3: Middleton K and Hing E. Adv Data. 2005 Dec 14;(366):1-36]
[4: Bower JR. Netter's Infectious Diseases 2012]

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

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