Walter Reed Evaluation Concludes OraQuick(R) HCV Test is Preferred Over Other Rapid Tests
02 Settembre 2008 - 12:00PM
Business Wire
OraSure Technologies, Inc. (NASDAQ:OSUR), a market leader in oral
fluid diagnostics, today announced that an evaluation by the Walter
Reed Army Institute of Research of the OraQuick� HCV Test,
currently in clinical development by OraSure Technologies, was
recently released at the Advanced Technology Applications for
Combat Casualty Care meeting, sponsored by the Department of
Defense. The purpose of the evaluation, entitled �Laboratory
Evaluation of Hepatitis C Rapid Test for Use in Screening Walking
Blood Bank Donors,� was to determine the best rapid HCV test to use
for screening blood donors for hepatitis C (�HCV�) in the theater
of war. The OraQuick� HCV test was selected as the preferred test
based on all facets of the evaluation. Blood that is donated to
commercial or hospital blood banks is subjected to extensive
testing for blood-borne pathogens before it is released to be used
in transfusions. However, emergency battlefield conditions
sometimes dictate that an available soldier, or Walking Blood Bank,
donate without this normal lab-based testing being available. A
rapid assay such as the OraQuick� HCV test can add a measure of
safety against this important blood borne virus. Five rapid tests
were initially selected from the rapid HCV tests available
worldwide, based on an evaluation of published claims and
sensitivity testing using HCV positive samples. The tests were then
compared in a comprehensive evaluation of test performance using
plasma and blood specimens. The study indicated that the OraQuick�
HCV test had the highest sensitivity (99.4%) and the highest
specificity (99.7%) among the tests evaluated. In addition, the
evaluation indicated that the OraQuick� HCV test detected HCV
antibodies approximately three days sooner than available
laboratory-based enzyme immunoassays and approximately sixteen days
earlier than the next most sensitive rapid HCV test. Early
detection of seroconversion is an important measure of the
sensitivity of a test and means that hepatitis C infection can be
identified even with relatively recent exposure. �We are very
pleased with the results of the Walter Reed evaluation,� said
Stephen R. Lee, Ph.D., Chief Science Officer of OraSure
Technologies. �We are eager to complete our clinical trials for the
OraQuick� HCV test and submit our applications for both FDA
approval and CE registration for this product. Based on the
performance data generated to date, we believe this test will play
an important future role in identifying new HCV infections and
enabling infected individuals to receive the care and treatment
they need.� The study was conducted at The Walter Reed Army
Institute of Research and involved investigators from the Walter
Reed Army Institute of Research Division of Retrovirology, The U.S.
Military HIV Research Program, Walter Reed Army Institute of
Research Division of Military Casualty Research, the U.S. Army
Blood Program, the Army Medical Department Center and School, the
Robertson Blood Center and the American Red Cross. Conference
information may be obtained at
https://www.usaccc.org/ATACCC/index.htm The OraQuick� HCV rapid
test is not currently approved by the U.S. Food and Drug
Administration (�FDA�) for use or sale in the United States.
OraSure Technologies is currently conducting clinical trials to
obtain FDA approval for the test utilizing multiple specimen types
including oral fluid, finger-stick and venous whole blood, plasma
and serum. The clinical studies are nearing completion and a
pre-market application is expected to be submitted to the FDA in
the near future. An application for CE mark approval, which is
required to sell the test in the European Union, is expected to be
filed shortly after the FDA submission. Approximately 170 million
people are chronically infected with hepatitis C worldwide, and
there are approximately three to four million new HCV infections
each year on a global basis. Chronic hepatitis C can cause
cirrhosis, liver failure and liver cancer. About half of all cases
of primary liver cancer in the developed world are caused by
hepatitis C, and hepatitis C-related liver disease is now the
leading cause for liver transplants. Most people who develop
chronic hepatitis C infection are not aware that they have the
disease. Identification and treatment of occult infections could
significantly reduce future morbidity and mortality associated with
HCV infection. 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 collection devices and assays to the life insurance
industry and public health markets for the detection of antibodies
to HIV. In addition, the Company supplies oral-fluid testing
solutions for drugs of abuse testing. For more information on the
Company, please go to www.orasure.com. About the Walter Reed Army
Institute of Research Walter Reed Army Institute of Research
(WRAIR) is the largest, most diverse, and oldest laboratory in the
US Army Medical Research and Material Command. It conducts research
on a range of militarily relevant issues, including naturally
occurring infectious diseases, combat casualty care, operational
health hazards, and medical defense against biological and chemical
weapons. WRAIR is the Department of Defense's lead agency for
infectious disease research and a crucial source of research
support for medical product development. About the United States
Military HIV Research Program The U.S. Military HIV Research
Program (USMHRP) is dedicated to HIV vaccine development,
prevention, disease surveillance and care and treatment for HIV.
This program builds on the strength of the U.S. military medical
research community, and addresses specific HIV research
requirements to meet its mission: prevention of HIV-1 disease in
the active force and, by extension, the global community at risk of
infection. USMHRP�s extensive diagnostics expertise including
familiarity with HIV rapid tests led the U.S. Army Blood Program to
engage with USMHRP for this HCV rapid test evaluation. USMHRP
information may be found at http://www.hivresearch.org/index.html
Important Information This press release contains certain
forward-looking statements, including with respect to products,
product performance, clinical studies, and regulatory submissions
and approvals. Actual results could be significantly different.
Factors that could affect results include the ability to market and
sell products; 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; inventory levels at distributors and other customers;
impact of replacing distributors; inventory levels at distributors
and other customers; impact of competitors, competing products and
technology changes; 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; 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; 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, 2007,
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.
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