OMH Osmetech

 

TIDMOMH 
 
RNS Number : 0835S 
Osmetech PLC 
12 May 2009 
 

12 May 2009 
 
 
Osmetech plc ("Osmetech" or the "Company") 
 
 
Osmetech chosen as principal supplier for a major clinical trial 
 
 
Osmetech plc (OMH.L), 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 
 
 
 
 
 
 
Osmetech plc+44 (0)207 849 6027 
James White, Chief Executive Officer    +1 626 463 2000 
David Sandilands, Chief Financial Officer 
 
 
Madano Partnership +44 (0) 207 593 4000 
Mark Way 
Matthew Moth 
www.madano.com 
 
 
Canacccord Adams Limited          +44 (0) 207 050 6500 
Robert Finlay 
Henry Fitzgerald-O'Connor 
 
 
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 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. 
 
 
 
 
 
This information is provided by RNS 
            The company news service from the London Stock Exchange 
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