OraSure Closes Enrollment in Final Clinical Study for Rapid HIV Over-the-Counter Test
09 Agosto 2011 - 12:00PM
OraSure Technologies, Inc. (Nasdaq:OSUR), the market leader in oral
fluid diagnostics, announced today that it has closed enrollment
for its multi-site clinical study 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, OraSure initiated the final phase of
clinical testing for an in-home HIV self-test kit in December 2010.
This phase consists of a multi-visit, blinded, unobserved user
study in which individuals conduct unsupervised oral fluid
self-testing using the investigational OTC version of the OraQuick
ADVANCE® Rapid HIV-1/2 test. Once all subject visits are completed
and study results are un-blinded, the performance of the OraQuick
ADVANCE® Rapid HIV-1/2 Antibody test in an OTC setting will be
compared with FDA-approved blood-based assay performance. One of
the study objectives specified by the FDA was to identify at least
100 HIV infected, but undiagnosed individuals. In order to
meet this requirement, the Company enrolled approximately 5,700
participants in the study across 20 clinical sites nationwide.
In planning for its FDA submission, the Company has decided to
split its filing into three separate parts or modules, the timing
of which will be spaced to allow the FDA sufficient review time
between modules. This is an accepted technique used to start the
formal review process as early as possible. The first of the three
modules is expected to be submitted to FDA in the third quarter;
the last of the modules, containing the results of the final
clinical study, is expected to be submitted around the end of the
year.
"We are extremely pleased to have reached this very significant
milestone in our clinical study. The ease of use and non-invasive
nature of the collection process makes our oral fluid rapid HIV
Test an ideal candidate device for in-home use by consumers," said
Douglas A. Michels, President and Chief Executive Officer of
OraSure Technologies. "We anticipate the completion of the
remainder of ongoing clinical study activities to occur sometime
late in the third quarter, followed by data analyses in the fourth
quarter. We look forward to continuing our work with the FDA
and the healthcare community to make a home-use rapid HIV test
available in the United States."
The Company also recently announced that the FDA and the
Company's notified body in Europe have both granted an extension of
shelf life to 30 months for the OraQuick HIV test. This is
significant, not just for the professional market, but also for the
over-the-counter market where the retail market typically requires
a shelf life of 24 months or more.
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.
About OraSure Technologies
OraSure Technologies is a leader in the development, manufacture
and distribution of oral fluid diagnostic devices and other
technologies designed to diagnose critical medical conditions and
diseases. Its innovative products include rapid tests for the
detection of antibodies to HIV and HCV at the point of care and
testing solutions for detecting various drugs of abuse. These
products enable healthcare providers to deliver critical
information to patients, empowering them to make decisions to
improve and protect their health. OraSure's products are sold
globally 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 products, clinical studies and regulatory
submissions. 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; 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; 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; ability to
identify, complete, integrate, and realize the full benefits of
potential future acquisitions, including the Company's acquisition
of DNA Genotek; 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; 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; 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 refinance
outstanding debt under expiring credit facilities on acceptable
terms or at all; 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; 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, 2010, 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: Investor Contact:
Ronald H. Spair
Chief Financial Officer
610-882-1820
Investorinfo@orasure.com
Media Contact:
Jennifer Moritz
Zer0 to 5ive for OraSure Technologies
917-748-4006
jmoritz@0to5.com
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