OraSure Initiates Enrollment in Final Clinical Study for OraQuick(R) Rapid HIV Over-the-Counter Test
13 12월 2010 - 8:00PM
OraSure Technologies, Inc. (Nasdaq:OSUR), the market leader in oral
fluid diagnostics, announced today that it has enrolled the first
subject in its final phase of clinical studies for United States
Food and Drug Administration ("FDA") approval of the Company's
OraQuick® Rapid HIV-1/2 test for sale in the U.S. consumer or
over-the-counter ("OTC") market.
As previously announced in November, the FDA granted an
Investigational Device Exemption ("IDE") which allowed OraSure to
begin the final phase of clinical testing for the at home HIV test
kit. This phase consists of an unobserved user study in which
individuals will conduct unsupervised oral fluid self-testing using
the investigational OTC version of the OraQuick ADVANCE ® Rapid
HIV-1/2 test.
OraSure also announced today that the FDA recently approved its
request to extend product expiration dating to 24-months for its
OraQuick ADVANCE ® Rapid HIV-1/2 test which is currently available
in the professional market. The FDA approval is based on prior
enhancements made by OraSure to the manufacturing process for this
product.
"We are extremely pleased to announce these two important
milestones in our quest for 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
believe that the OraQuick® test, with its robust technology, ease
of use, and oral fluid testing capability, is the best rapid HIV
test available on the market, and is ideally suited for consumer
self testing. We look forward to the successful completion of our
clinical studies and the formal submission of our clinical data as
we continue our work with the FDA to make an at home rapid HIV test
kit available in the United States."
OraQuick ADVANCE ® is the first and only FDA-approved and
CLIA-waived rapid point-of-care test that can detect antibodies to
both HIV-1 and HIV-2 in 20 minutes, using oral fluid, finger-stick
or venipuncture whole blood or plasma specimens. As the market
leader, OraQuick ADVANCE ® is used extensively throughout the
country in public health settings, hospitals, community-based
organizations, and physician offices where HIV testing is
conducted.
According to the Centers for Disease Control and Prevention,
approximately 1.1 million individuals in the United States are
infected with HIV, yet approximately one-quarter do not know they
have the disease.
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, markets, sales
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
Media Contact:
Jennifer Moritz
917-748-4006
jmoritz@0to5.com
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