XT-8 platform wins Medical Design Excellence Award
14 Mai 2009 - 8:01AM
RNS Non-Regulatory
TIDMOMH
Osmetech PLC
14 May 2009
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14 May 2009
Osmetech plc ("Osmetech" or the "Company")
Osmetech's eSensor XT-8 platform wins Medical Design Excellence Award
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
(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.
Osmetech plc +44 (0)207 849 6027
James White, Chief Executive Officer +1 626 463 2000
This information is provided by RNS
The company news service from the London Stock Exchange
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