OraSure Technologies Receives FDA Approval to Conduct Final Phase of Clinical Studies for OraQuick(R) Over-the-Counter HIV Test
22 11월 2010 - 8:00PM
OraSure Technologies, Inc. (Nasdaq:OSUR), the market leader in oral
fluid diagnostics, today announced that the U.S. Food and Drug
Administration ("FDA") has granted an investigational device
exemption (IDE) for the Company to conduct the final phase of
clinical testing for FDA approval of its OraQuick® Rapid HIV-1/2
Antibody Test for sale in the consumer or over-the-counter ("OTC")
market.
Receipt of the IDE allows the Company to proceed with the final
phase of clinical testing which consists of a study in which
individuals will conduct unsupervised self-testing using the
investigational OTC version of the OraQuick® HIV test with an oral
fluid collection.
As previously announced, OraSure has already initiated site
selection, training and preparation and Institutional Review Board
(IRB) review for this final phase and expects enrollment to begin
before the end of the year.
"We are extremely pleased to have approval to begin the final
phase of studies to support our efforts to obtain FDA approval for
an over-the-counter offering of our OraQuick® HIV test," said
Douglas A. Michels, President and Chief Executive Officer of
OraSure Technologies. "We look forward to continuing our work with
the FDA and other members of the community to make a home use rapid
HIV test available in the United States."
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.
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 expected clinical studies and regulatory
approvals. Forward-looking statements are not guarantees of future
performance or results. Known and unknown factors that could cause
actual performance or results to be materially different from those
expressed or implied in these statements include, but are not
limited to: 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 or other parties 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
poor credit conditions; reduction or deferral of public funding
available to customers; competition from new or better technology
or lower cost products; 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, extended shelf life or other factors;
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; ability to utilize net
operating loss carry forwards or other deferred tax assets;
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, including the impact of
changes in international funding sources and testing algorithms;
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; 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 Company's Securities and Exchange Commission
filings, including its registration statements, Annual Report on
Form 10-K for the year ended December 31, 2009, Quarterly Reports
on Form 10-Q, and other filings with the SEC. Although
forward-looking statements help to provide 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.
CONTACT: OraSure Technologies, Inc.
Investor Contact:
Ronald H. Spair, Chief Financial Officer
610-882-1820
Investorinfo@orasure.com
Zer0 to 5ive for OraSure Technologies
Media Contact:
Jennifer Moritz
917-748-4006
jmoritz@0to5.com
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