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Osmetech plc ('Osmetech' or the 'Company')
Warfarin Sensitivity study results
Update on proposed issue of American Depositary Shares
31 October 2008
Osmetech plc (OMH.L), the international molecular diagnostics company announces that Dr. Charles S. Eby, M.D., Associate Professor at the Washington University in St. Louis School of Medicine has presented the results of an evaluation performed in his laboratory of Osmetech’s Warfarin Sensitivity Test on the eSensor® XT-8 instrument at the annual meeting of the Association for Molecular Pathology (AMP) in Texas, US. The results of this evaluation were outstanding, with 100% accuracy and reproducibility for the 440 sample calls made. The tests provided results within 4 hours beginning with genomic DNA, with the random access capability of the System allowing multiple samples to be processed as and when required.
Dr. Eby also presented an overview of pharmacogenetic testing for warfarin sensitivity, including plans for a prospective, multi-center study of pharmacogenetic-based warfarin dosing sponsored by the National Heart, Lung and Blood Institute.
James White, Chief Executive, Osmetech plc, said:
"We are delighted that the excellent clinical trials results submitted to the FDA for the clearance of our Warfarin Sensitivity test are being replicated in the field. In addition to high levels of accuracy, sensitivity and reliability from the results from Dr Eby’s study, the eSensor XT-8 System has enabled testing to be performed with a minimal number of manual steps and a rapid turnaround time on an easy to use, small instrument with random access capabilities. The excellent data quality and user friendly attributes of the recently launched eSensor XT-8 System are helping to increase instrument placements which will benefit further from additional tests scheduled for launch including Cystic Fibrosis, CYP450 2C9 drug metabolism, venous thrombosis (Factor II, Factor V Leiden and MTHFR) and the recently in-licensed Qiagen RESPLEX II respiratory pathogen assay.”
Proposed issue of American Depositary Shares (“ADSs”)
Osmetech continues to progress the proposed issue of ADSs in challenging market conditions. A further announcement will be made in due course.
Warfarin sensitivity test
Warfarin is the most widely prescribed oral anticoagulant in North America and Europe with an estimated 2 million new patients in the US each year. Warfarin is the second-most-likely drug, after Digoxin, to cause adverse events requiring hospitalization. A recent economic study (Brookings Institute, November 2006) concluded that widespread use of warfarin sensitivity testing in the U.S. could avoid 85,000 serious-bleeding events and 17,000 strokes a year, saving healthcare costs of approximately $1.1 billion annually and improving patient care.
Our eSensor Warfarin Sensitivity Test detects the three genetic markers that are known to play a critical role in metabolism of, and sensitivity to, warfarin. Through detection of these genetic markers, doctors are better able accurately and efficiently to determine the appropriate warfarin dosage level. Individuals respond to warfarin differently, and if its administration is not managed carefully, life threatening side effects may occur. Last year, the FDA cleared updated labelling for Coumadin® (generic name warfarin) recognizing the role of CYP2C9 and VCORC1 genes in warfarin metabolism.
eSensor XT-8
Our second generation platform, the eSensor XT-8, is designed to support a broad menu of tests and provide accurate results while minimizing technician involvement. We believe that the features of our eSensor XT‑8 System compare favorably to those of other molecular detection systems and that its ease of use, readily interpretable results, speed and low maintenance are particularly suited to the needs of the decentralizing market.
Osmetech plc +44 (0)207 849 6027
James White, Chief Executive Officer
David Sandilands, Chief Financial Officer
Madano Partnership +44 (0) 207 593 4000
Matthew Moth, Mark Way
Canacccord Adams Limited +44 (0) 207 050 6500
Robert Finlay, Warren Pimm
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.