Osmetech’s eSensor XT-8 platform wins Medical Design Excellence Award
Pasadena, CA., (May 14, 2009) – Osmetech plc (OMH.L), the international molecular diagnostics company, announces that it has received a Medical Design Excellence Award for innovative device design. The Company has received a 2009 Medical Design Excellence Award for its eSensor® XT-8 molecular diagnostics platform, initially launched with a Warfarin Sensitivity Test.
The FDA-cleared device produces results in less than 30 minutes detecting multiple genetic markers from a prepared patient sample. Using proprietary electro-chemical technology, the self-contained cartridge consumable contains 72 gold-plated electrodes, each acting as independent DNA microsensors on a printed circuit board.
The instrument provides an easy-to-use graphical, touch screen interface, a small footprint, requires limited operator training, low maintenance and no instrument calibration. Each cartridge slot operates independently supporting the use of a wide variety of tests and the system’s modular design enables the capacity requirements of high throughput users to be met.
James White, Chief Executive Officer, Osmetech plc, said:
"We are delighted that our eSensor XT-8 System and Warfarin Sensitivity Test has received this independent award. This is further recognition for our innovative, practical and cost-effective platform which is rapidly gaining market acceptance illustrated by our selection as principal supplier of Warfarin Sensitivity tests for a major new US trial sponsored by the US National Heart, Lung, and Blood Institute.”
About the Medical Design Excellence Award competition
The Medical Design Excellence Awards competition is organized and presented by Canon Communications LLC (Los Angeles) and is the only awards program that exclusively recognizes contributions and advances in the design of medical products. Entries are evaluated on the basis of their design and engineering features, including innovative use of materials, user-related functions that improve healthcare delivery and change traditional medical attitudes or practices, features that provide enhanced benefits to the patient and the ability of the product development team to overcome design and engineering challenges so that the product meets its clinical objectives.
A comprehensive review of the entries was performed by a multidisciplinary panel of third-party jurors with expertise in biomedical engineering, human factors, industrial design, medicine and diagnostics.
About 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
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.
Osmetech plc +44 (0) 207 849 6027
James White, Chief Executive Officer +1 626 463 2000