Osmetech Submits Swine Flu Test to the FDA
14 Maio 2009 - 10:00AM
Business Wire
Osmetech (LSE:OMH) today announced that it has submitted a
request to the US FDA for Emergency Use Authorization (EUA) for its
Respiratory Pathogen Test Panel test to be used to screen for the
swine flu virus.
Osmetech�s Respiratory Pathogen Test Panel test, which is
expected to be launched as a research use only (RUO) product next
quarter, detects and differentiates between 18 common bacterial and
viral infections, including the Influenza A virus and its H1N1
subtype. Osmetech is currently developing an extension to the
Respiratory Pathogen Test that will differentiate this H1N1 subtype
between the human and swine forms of the virus.
Osmetech Respiratory Pathogen Test Panel test has been adapted
from QIAGEN�s QIAplex-based respiratory viral test for use on
Osmetech�s eSensor XT-8 molecular diagnostics system, under the
terms of an agreement signed in September 2008.
James White, Chief Executive, Osmetech plc, said:
"We believe that our test is ideally suited for fast and
reliable screening of Influenza A virus types, including the swine
flu strain which is currently a major pandemic concern. The test
will be run on our eSensor XT-8 platform, which is a small,
portable and easy to use platform that has the potential to enable
testing to occur in numerous locations."
About Swine Flu:
Swine flu (swine influenza) is a highly contagious respiratory
disease of pigs, caused by one of several swine influenza A
viruses. Since pigs can be infected with more than one virus type
at a time, genes of several viruses from various sources (including
humans) can mix, allowing the swine influenza viruses to cross
species barrier and eventually cause disease in humans. The
clinical symptoms then are similar to seasonal influenza and other
acute upper respiratory tract infections, in some cases leading to
severe pneumonia and resulting in death. However, since mild or
asymptomatic cases may have escaped from recognition, the true
extent of this disease among humans is still unknown. Currently,
there is no human vaccine on the market which protects against
swine influenza. Antiviral drugs are available in many countries.
More information on the swine flu is available on
http://www.who.int/.
About Osmetech plc (www.osmetech.com)
Osmetech plc is an AIM-listed public company on the London Stock
Exchange. The Company is a fast developing, international
diagnostics business with operations in Boston and Pasadena in the
US, serving the high growth molecular diagnostic market targeting
hospitals and reference laboratories.
Osmetech has a strong portfolio of over 200 issued and pending
patents and has launched its first generation eSensor 4800
platform, an electrochemistry-based array system, together with an
FDA cleared in vitro diagnostic test for Cystic Fibrosis carrier
detection.
Osmetech�s second generation platform, the eSensor XT-8 received
FDA 510(k) clearance in July 2008 together with our eSensor
Warfarin Sensitivity Test. These products are now being marketed in
the U.S. together with a 2C9 Genotyping Test for drug metabolism
and a Cystic Fibrosis carrier detection test which are both
available for research use purposes only.
In April 2009, Osmetech signed a five-year distribution
agreement with Fisher HealthCare, a part of Thermo Fisher
Scientific, whereby Fisher HealthCare will distribute Osmetech�s
eSensor XT-8 instrument platform and molecular diagnostic tests and
consumables in the U.S.
The eSensor XT-8 System is designed to support a broad menu of
tests and Osmetech has scheduled for commercial launch a number of
further tests including: extended warfarin panel with the
proprietary 4F2 marker, venous thrombosis (Factor II, Factor V
Leiden and MTHFR) and the RESPLEX II respiratory pathogen assay
in-licensed from Qiagen. The System provides accurate results while
minimizing technician involvement and its features compare
favorably to those of other molecular detection systems. Its ease
of use, readily interpretable results, speed and low maintenance
are particularly suited to the needs of the decentralizing
market.
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