9:00 | 15.12.2009
DGAP-News: Photo Release — OraSure Technologies Receives CE Mark for OraQuick(R) Rapid HCV Antibody Test
OraSure Technologies, Inc. /
15.12.2009
Dissemination of a Corporate News, transmitted by
DGAP – a company of EquityStory AG.
The issuer / publisher is solely responsible for the content of this announcement.
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First and Only Oral Fluid Rapid HCV Test Bearing a CE Mark
BETHLEHEM, Pa., Dec. 15, 2009 (GLOBE NEWSWIRE) — OraSure Technologies, Inc.
(Nasdaq:OSUR) announced today that it has received approval to affix the CE
mark to its OraQuick(R) Rapid HCV Antibody Test. A CE mark is required to sell
this test in the 27 countries that currently make up the European Union. The
OraQuick(R) Rapid HCV Antibody Test is the first and only rapid Hepatitis C
test bearing a CE mark that can be used with oral fluid.
A photo accompanying this release is available at
http://www.globenewswire.com/newsroom/prs/?pkgid=6919
‘We believe that the OraQuick(R) Rapid HCV Antibody Test, with its ability to
test using a simple oral fluid or finger-stick blood sample, will be a valuable
tool in identifying more individuals infected with Hepatitis C.’ said Douglas
A. Michels, President and Chief Executive Officer of OraSure Technologies. ‘CE
mark approval of our OraQuick(R) Rapid HCV Antibody Test represents a
significant achievement and major milestone for our Company.’
On a world-wide basis, there are an estimated 180 million people who are
chronically infected with HCV, with an estimated three to four million
individuals newly infected each year. According to the World Health
Organization, most HCV infection is currently undiagnosed and up to 80 percent
who have HCV show no signs or symptoms.
According to a new report issued by the UK Health Protection Agency on December
11, 2009, entitled ‘Hepatitis C in the UK – The Health Protection Agency Annual
Report 2009,’ it is currently estimated that approximately 185,000 individuals
in the UK are chronically infected with Hepatitis C, including more than 8,000
people who were diagnosed in 2008 in England.
‘This new hepatitis C test will help to diagnose people before their livers are
damaged beyond repair,’ said Charles Gore, Chief Executive of The Hepatitis C
Trust, the national charity for HCV in the United Kingdom. ‘Hepatitis C is
preventable and treatable so it’s a scandal that the death toll continues to
rise simply because people haven’t yet been diagnosed. The UK desperately needs
to diagnose the 100,000 patients who are unaware they are living with the virus
and to stop further transmissions. This simple, quick test will allow us to
reach more people who would otherwise not have access to testing.’
The European Union requires companies to comply with the Medical Devices
Directive (’MDD’) and In Vitro Diagnostics Directive (’IVDD’) in order to sell
medical devices in Europe. The CE mark is evidence that OraSure and its
OraQuick(R) Rapid HCV Antibody Test meet the quality and other requirements of
these directives. The Company is currently pursuing the required individual
country registrations and expects to begin selling the test in Europe during
the first quarter of 2010.
As previously announced, OraSure has entered into agreements with Merck & Co.
(through its predecessor Schering Plough Corporation) to collaborate on the
development and promotion of the OraQuick(R) HCV test. Under the terms of these
agreements, the Company has been and will be reimbursed by Merck for a portion
of its costs to develop the test and obtain regulatory approvals. Additionally,
Merck will provide promotional support, including detailing the test in the
physicians’ office market worldwide.
With the CE Mark, the OraQuick(R) Rapid HCV Antibody Test is the second rapid
test manufactured by OraSure to receive such approval. In June 2007, OraSure
received approval to affix the CE mark to its OraQuick ADVANCE(R) Rapid HIV-1/2
Antibody Test which is currently being sold throughout the European Union.
OraSure is also actively seeking approval of its OraQuick(R) Rapid HCV Antibody
Test by the U.S. Food and Drug Administration (FDA).
About OraSure Technologies
OraSure Technologies develops, manufactures and markets oral fluid specimen
collection devices using proprietary oral fluid technologies, diagnostic
products including immunoassays and other in vitro diagnostic tests, and other
medical devices. These products are sold in the United States as well as
internationally to various clinical laboratories, hospitals, clinics,
community-based organizations and other public health organizations,
distributors, government agencies, physicians’ offices, and commercial and
industrial entities.
OraSure Technologies is the leading supplier of oral-fluid testing solutions
for drugs of abuse and for the detection of antibodies to HIV.
For more information on the Company, please go to www.orasure.com.
The OraSure Technologies, Inc. logo is available at
http://www.globenewswire.com/newsroom/prs/?pkgid=6440
Important Information
This press release contains certain forward-looking statements, including with
respect to product sales and registrations. Actual results could be
significantly different. Factors that could affect results include the ability
to market and sell products, whether through an internal, direct sales force or
third parties; ability to manufacture products in accordance with applicable
specifications, performance standards and quality requirements; changes in
relationships, including disputes or disagreements, with strategic partners and
reliance on strategic partners for the performance of critical activities under
collaborative arrangements; failure of distributors or other customers to meet
purchase forecasts or minimum purchase requirements for the Company’s products;
impact of replacing distributors and success of direct sales efforts; inventory
levels at distributors and other customers; impact of competitors, competing
products and technology changes; impact of the economic downturn, high
unemployment and credit crisis; ability to develop, commercialize and market
new products; market acceptance of oral fluid testing or other products;
changes in market acceptance of products based on product performance and
extended shelf life; continued bulk purchases by customers, including
governmental agencies, and the ability to fully deploy those purchases in a
timely manner; ability to fund research and development and other products and
operations; ability to obtain and maintain new or existing product distribution
channels; reliance on sole supply sources for critical product components;
availability of related products produced by third parties or products required
for use of our products; ability to obtain, and timing and cost of obtaining,
necessary regulatory approvals for new products or new indications or
applications for existing products; ability to comply with applicable
regulatory requirements; history of losses and ability to achieve sustained
profitability and ability to utilize net operating loss carryforwards or other
deferred tax assets; volatility of the Company’s stock price; uncertainty
relating to patent protection and potential patent infringement claims;
uncertainty and costs of litigation relating to patents and other intellectual
property; availability of licenses to patents or other technology; ability to
enter into international manufacturing agreements; obstacles to international
marketing and manufacturing of products; ability to sell products
internationally, including changes in international funding sources; loss or
impairment of sources of capital; ability to meet financial covenants in
agreements with financial institutions; ability to retain qualified personnel;
exposure to patent infringement, product liability, and other types of
litigation; changes in international, federal or state laws and regulations;
customer consolidations and inventory practices; equipment failures and ability
to obtain needed raw materials and components; the impact of terrorist attacks
and civil unrest; ability to identify, complete and realize the full benefits
of potential acquisitions; and general political, business and economic
conditions. These and other factors are discussed more fully in the Securities
and Exchange Commission (’SEC’) filings of OraSure Technologies, including its
registration statements, its Annual Report on Form 10-K for the year ended
December 31, 2008, its Quarterly Reports on Form 10-Q, and its other filings
with the SEC. Although forward-looking statements help to provide complete
information about future prospects, readers should keep in mind that
forward-looking statements may not be reliable. The forward-looking statements
are made as of the date of this press release and OraSure Technologies
undertakes no duty to update these statements.
The photo is also available via AP PhotoExpress.
CONTACT: OraSure Technologies
Investor Contact:
Ronald H. Spair, Chief Financial Officer
610-882-1820
investorinfo@orasure.com
Zer0 to 5ive for OraSure Technologies
Media Contact:
Marybeth Sheppard
646-808-4986
Marybeth@0to5.com
Axis Shield
Katrina Peacock – UK
Katrina.peacock@axis-shielduk.com
News Source: NASDAQ OMX
15.12.2009 Ad hoc announcement, Financial News and Media Release distributed by DGAP. Medienarchiv at
www.dgap-medientreff.de
and
www.dgap.de
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Language: English
Company: OraSure Technologies, Inc.
US
Phone:
Fax:
E-mail:
Internet:
ISIN: US68554V1089
WKN:
End of News DGAP News-Service
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