Osmetech Chosen as Principal Supplier for a Major Clinical Trial
13 Maio 2009 - 10:00AM
Business Wire
Osmetech plc (LSE:OMH) (�Osmetech� or the �Company�), the
international molecular diagnostics company, announces that it has
signed an agreement as principal supplier of Warfarin Sensitivity
tests for a major new US trial sponsored by the US National Heart,
Lung, and Blood Institute (NHLBI), part of the National Institutes
of Health (NIH) in the US.
Investigators for the upcoming Clarification of Optimal
Anticoagulation through Genetics Trial (COAG Trial) have selected
Osmetech�s Warfarin Sensitivity Tests and eSensor XT-8 molecular
diagnostics instrument platform for ten of the twelve sites
identified to run the trial. The University of Pennsylvania is the
Coordinating Center for the trial.
The study has been designed as a 1,238 patient, randomized,
double-blind trial which will examine the utility of using genetic
information for warfarin dosing. Specifically, the COAG Trial will
test two approaches to determining the initial dose of warfarin in
patients who are expected to need therapy for three months or
longer. Half of the participants enrolled in COAG will be randomly
selected to have their initial dose determined by clinical
information alone. For the other half of the participants, the
initial dose will be determined by using the clinical factors as
well as information about the participant's genetic makeup,
specifically his or her variants of the CYP2C9 and VKORC1 genes.
All participants will be monitored for up to six months.
Researchers will assess how long participants in each group
maintain the desired level of blood thinning, as determined by a
blood test, at two and four weeks after starting therapy, as well
as at three and six months. Researchers will also review bleeding
problems and other complications, quality of life and cost of
therapy.
James White, Chief Executive Officer, Osmetech plc,
said:
"The high level of performance of our eSensor XT-8 System and
Warfarin Sensitivity Test in the market since commercial launch in
the second half of 2008 continues to gain recognition and this
contract award should further enhance market acceptance of our
platform.
"Osmetech has won an opportunity to participate in a major study
which will demonstrate the significance of genetic and clinical
data in the prescription of a patient�s initial warfarin dose. The
strength of our eSensor XT-8 platform and pipeline of tests puts us
in an excellent position to benefit from the growing trend towards
personalized medicine."
Dr. Stephen Kimmel of the University of Pennsylvania and lead
investigator of the COAG Coordinating Center said:
"We considered a number of alternative products and technologies
for this important study, taking into account a number of factors
including product performance and users� experiences. We are
pleased to be using Osmetech�s eSensor XT-8 System and Warfarin
Sensitivity Test as one of the trial�s main genotyping platforms
which should provide accurate, reliable and timely results from an
easy to use and low maintenance system."
Further information about the COAG trial can be found at:
http://coagstudy.org/
NHLBI press release about the trial:
http://public.nhlbi.nih.gov/Newsroom/Home/GetPressRelease.aspx?id=2623
Warfarin sensitivity testing
Warfarin is an oral anticoagulant widely used for the prevention
of thrombotic events and to treat a confirmed episode of venous
thrombosis, with approximately 2 million new patients each year in
the US alone. Although highly effective, warfarin�s usability is
limited by a narrow therapeutic range combined with a pronounced
interindividual variability in the dose required for adequate
anticoagulation. Clinical use of warfarin is further complicated by
a substantial risk for hemorrhagic side effects, which is increased
in patients with low-dose requirements. Warfarin is the
second-most-likely drug, after Digoxin, to cause adverse events
requiring hospitalization.
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 US 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 US.
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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