BETHLEHEM, Pa.--(BUSINESS WIRE)--Sept. 9, 2003--OraSure
Technologies, Inc. (Nasdaq NM:OSUR), the market leader in oral fluid
diagnostics, announced today that its OraQuick(R) Rapid HIV-1 Antibody
Test has been approved by the U.S. Food and Drug Administration
("FDA") for use in detecting HIV-1 antibodies in venipuncture whole
blood specimens.
This is the second claim approved by the FDA for the OraQuick(R)
test. In November 2002, the Company received approval for use of the
OraQuick(R) test with fingerstick whole blood specimens. The new
approval for venipuncture whole blood is expected to expand the use of
the test, especially in hospitals where venipuncture whole blood
samples are routinely drawn from patients for testing. Sales of the
OraQuick(R) test for use with venipuncture whole blood are subject to
the completion of final product labeling incorporating this new claim,
which is currently under review by the FDA.
"Receiving FDA approval of a venipuncture whole blood claim is
another significant step in our quest to make OraQuick(R) the most
versatile rapid HIV-1 test available in the U.S. market," said Mike
Gausling, Chief Executive Officer of OraSure Technologies. "This
approval should help open the door for hospitals to incorporate the
OraQuick(R) test more readily when drawing venous whole blood
specimens."
OraQuick(R) is the first rapid, point-of-care test approved by the
FDA to detect antibodies to HIV-1 in fingerstick and venipuncture
whole blood specimens within approximately 20 minutes. OraSure
received FDA approval of the OraQuick(R) test for fingerstick whole
blood on November 7, 2002. On January 31, 2003, OraSure received a
CLIA waiver for the test, permitting its use by more than 180,000
sites in the United States, including outreach clinics,
community-based organizations and physicians' offices.
OraSure is completing the clinical trials for usage of the
OraQuick(R) device with oral fluid and plasma samples, and expects to
file submissions for these claims with the FDA in the near future. In
addition, OraSure has completed the necessary clinical trials and
filed for FDA approval for use of the OraQuick(R) device to detect
antibodies to a second type of the HIV virus, known as HIV-2. This
action was taken by OraSure in anticipation of obtaining access to an
HIV-2 patent license, either through another party or directly with
the holder of certain patents covering the HIV-2 virus.
About OraSure Technologies
OraSure Technologies develops, manufactures and markets oral fluid
specimen collection devices using proprietary oral fluid technologies
and diagnostic products, including immunoassays and other in vitro
diagnostic tests and other medical devices. These products are sold in
the United States and certain foreign countries to various
distributors, government agencies, clinical laboratories, physicians'
offices, hospitals, 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-1. 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.
Important Information
This press release contains certain forward-looking statements,
including with respect to sales, markets, regulatory filings and
approvals, and products. Actual results could be significantly
different. Factors that could affect results include the ability to
market products; impact of competitors, competing products and
technology changes; ability to develop, commercialize and market new
products; market acceptance of oral fluid testing products and
up-converting phosphor technology products; ability to fund research
and development and other projects and operations; ability to maintain
new or existing product distribution channels; reliance on sole supply
sources for critical product components; availability of related
products produced by third parties; ability to obtain and timing of
obtaining necessary regulatory approvals; 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; 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 and other types of
litigation; changes in international, federal or state laws and
regulations; changes in relationships with strategic partners and
reliance on strategic partners for the performance of critical
activities under collaborative arrangements; changes in accounting
practices or interpretation of accounting requirements; 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, 2002, 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.
