OraSure Technologies Announces Pre-Clinical Study Results for Prototype Rapid HCV Antibody Test at AACC Annual Meeting
19 Luglio 2007 - 6:00PM
Business Wire
OraSure Technologies, Inc. (NASDAQ:OSUR), the market leader in oral
fluid diagnostics, today announced pre-clinical study results for a
prototype rapid Hepatitis C (�HCV�) antibody test on the Company�s
OraQuick� test platform, using oral fluid, finger-stick whole
blood, venous whole blood, serum and plasma samples. These results
were reported by OraSure at the 2007 Annual Meeting of the American
Association of Clinical Chemistry held in San Diego, California. In
pre-clinical studies conducted by the Company, performance of the
prototype HCV test for all specimen types was shown to be
equivalent to or better than results obtained from currently
available, state of the art laboratory-based enzyme immunoassay
tests using serum and plasma specimens. Additional information
regarding the preclinical study results presented by OraSure at the
ACC Annual Meeting can be found at www.orasure.com/aacc. �We are
very pleased with the pre-clinical results generated by our
prototype OraQuick� rapid HCV antibody test,� said Douglas A.
Michels, President and CEO of OraSure Technologies. �Our
development efforts are proceeding on schedule, and we intend to
begin the final clinical studies required to obtain FDA approval
during the next several months. Our plan is to complete these
studies as soon as possible and file an application for FDA
approval in early 2008. Assuming we are successful, we expect that
our test will be the first rapid HCV antibody test approved by the
FDA for use in the United States.� Prospective pre-clinical testing
of 419 low-risk human subjects using oral fluid, finger stick and
venous whole blood, serum and plasma, generated concordant results
across all specimen types for each individual. Specificity, which
is the percentage of tests that correctly show a negative result
when an individual is not infected, was 99.8% in all specimen
types. Three individuals in this group were newly identified as
having been infected with HCV. In testing of 92 individuals known
to be infected with HCV, pre-clinical results indicated sensitivity
in venous whole blood and oral fluid of 100%. In addition, 639
archived HCV-positive plasma samples were tested and similarly
resulted in 100% sensitivity. Sensitivity is a measure of the
percentage of tests that correctly show a positive result when an
individual is infected with HCV. The pre-clinical studies also
evaluated the test�s sensitivity during seroconversion.
Seroconversion refers to the period of time immediately after
infection during which an individual�s body generates detectable
antibodies to HCV. Out of 22 seroconversion panels tested, the
prototype HCV test detected HCV antibody on average three days
earlier than a laboratory-based assay and in no case did the
prototype test detect HCV antibody later than the laboratory assay.
Hepatitis C is the most common blood-borne infection in America,
affecting approximately four million people or about one in every
50 adults, according to the Centers for Disease Control and
Prevention. Most people who contract the disease will develop
chronic hepatitis C infection and more than half of infected
persons are not aware that they have the disease. 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. Without increased
therapeutic treatment, the number of deaths from HCV infection is
expected to increase substantially over the next 10 to 20 years due
to the progression of liver disease in the infected population.
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. For
more information on the Company, please go to www.orasure.com.
Important Information This press release contains certain
forward-looking statements, including with respect to products,
product performance, clinical studies, regulatory filings and the
effects of HCV infection. 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 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 our 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; loss or
impairment of sources of capital; ability to meet financial
covenants in agreements with financial institutions; ability to
retain qualified personnel; exposure to product liability, patent
infringement, 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 complete
consolidation or restructuring activities; 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, 2006, 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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