Osmetech’s eSensor XT-8 platform wins Medical Design Excellence Award
14 Maio 2009 - 10:15AM
Business Wire
Osmetech plc (AIM:�OMH) (�Osmetech� or the �Company�), 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.
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