Osmetech Announces First Shipments of New eSensor(R) XT-8 Platform and Warfarin Sensitivity...
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Osmetech Announces First Shipments of New eSensor(R) XT-8 Platform and Warfarin Sensitivity Test
LONDON--(Business Wire)--
Speaking at the American Association for Clinical Chemistry (AACC)
2008 Conference and Exhibition in Washington, DC, James White, Chief
Executive, Osmetech plc (LSE:OMH), confirmed that following receipt of
its 510(k) clearance last week from the US Food & Drug Administration
('FDA'), the Company has now commenced shipments of its second
generation eSensor(R) XT-8 molecular diagnostics platform and Warfarin
Sensitivity Test.
Mr White said: "We are delighted with the initial response from
customers following the FDA clearance of the product and have a number
of shipments planned to both existing customers, who are currently
running Cystic Fibrosis Carrier Detection tests using our first
generation platform, and new customers.
"This additional product offering leverages our commercial
infrastructure which has benefited greatly from the valuable
experience and momentum gained through servicing our Cystic Fibrosis
test customers. As is customary in the molecular diagnostics market,
the new products will initially be evaluated by customers and we are
confident of achieving a high conversion rate of customers from
evaluation to contract, mirroring our experience with our Cystic
Fibrosis product.
"We will be broadening our test menu for the eSensor XT-8 platform
and have further FDA submissions for specific tests planned for later
this year and in 2009."
About Osmetech plc
(www.osmetech.com)
Osmetech plc is a public company listed on the AIM market of 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 rights to 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. In July 2008, Osmetech received
FDA clearance for its second generation eSensor XT-8 molecular
diagnostics platform and Warfarin Sensitivity Test.
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 insulin, to
cause adverse events requiring emergency room visits. 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 to accurately and efficiently 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
labeling for Coumadin(R) (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
James White, Chief Executive Officer
David Sandilands, Chief Financial Officer
+44 (0)207 849 6027
or
Madano Partnership
Matthew Moth, Mark Way
+44 (0) 207 593 4000
or
Canacccord Adams Limited
Robert Finlay
+44 (0) 207 050 6500
Copyright Business Wire 2008
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