OraSure Technologies, Inc. (Nasdaq:OSUR), a market leader in rapid
point-of-care infectious disease diagnostics and biological sample
collection, stabilization and preparation products, announced today
that it has submitted the final of three modules in its application
to the U. S. Food and Drug Administration (FDA) for the approval of
the Company's OraQuick® Rapid HIV-1/2 test for sale in the U.S.
consumer or over-the-counter (OTC) market.
The third module contains the findings from the final phase of
clinical testing, which involved the use of the OraQuick® Rapid
HIV-1/2 test with subjects in an unobserved setting. Approximately
5,800 subjects were enrolled and tested in this phase across 20
sites nationwide, resulting in the identification of more than 100
previously undiagnosed individuals with HIV.
According to the Centers for Disease Control and Prevention
(CDC), there are approximately 1.2 million people in the U.S. that
have HIV and approximately 240,000 of them are unaware of their
status, despite current HIV testing options. Not only is their own
health at risk, they are also unknowingly responsible for up to 70
percent of the approximately 50,000 new HIV infections occurring
each year in the U.S. The CDC recommends routine HIV screening for
all people ages 13 to 64, with more frequent testing for people at
higher risk.
"The latest CDC figures demonstrate the status quo for testing
is inadequate and additional options to capture undiagnosed
individuals infected with HIV must be brought to the market. We've
been working closely with the community and FDA on the development
of a powerful new HIV testing option for individuals. This
submission was a major undertaking for OraSure and the culmination
of years of hard work and financial commitment. An easy-to-use,
private, and accurate in-home HIV test will enable more people to
learn their presumptive HIV status so that they can receive
necessary care and support," said Douglas A. Michels, President and
Chief Executive Officer of OraSure Technologies. "The completion of
our submission to the FDA is a critical milestone in our efforts to
secure approval and expand the tools available to combat the spread
of HIV."
The final phase of clinical testing consisted of a multi-visit,
blinded, unobserved user study in which individuals conducted
unsupervised oral fluid self-testing using an investigational OTC
version of the OraQuick ADVANCE® Rapid HIV-1/2 test. Once all
subject tests were complete and study results unblinded, the
performance of the OraQuick HIV test in the unobserved OTC setting
was compared with FDA-approved laboratory HIV test results.
The Company intends to provide the necessary resources to ensure
optimal support for individuals who, pending approval, would then
be able to use the OraQuick HIV test in an OTC setting. In addition
to a highly informative website, OraSure will offer "live" support
and comprehensive referral services 24 hours a day, seven days a
week, every day of the year, through a highly trained specialized
toll-free call center, which was functional as part of the clinical
trials. Detailed, easy-to-understand information on HIV and HIV
testing was part of the clinical studies as well and will also be
included in every test kit.
The first module for FDA review was submitted to the agency in
the third quarter of 2011 and contained data from all studies
performed prior to the final phase of testing. The second module
was submitted to the FDA several weeks ago and included information
about manufacturing and the customer care call center.
In the professional market, OraSure manufactures and sells the
OraQuick ADVANCE® Rapid HIV 1/2 Test which 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 leading rapid HIV test with over 20
million tests sold, 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 rapid point-of-care infectious disease tests,
collection devices and other technologies designed to detect or
diagnose critical medical conditions. 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. In addition, through its wholly-owned subsidiary,
DNA Genotek Inc., the Company also is a leading provider of oral
fluid sample collection, stabilization and preparation products for
molecular diagnostic applications. OraSure's portfolio of products
is sold globally to various clinical laboratories, hospitals,
clinics, community-based organizations and other public health
organizations, research and academic institutions, distributors,
government agencies, physicians' offices, and commercial and
industrial entities. The Company's products enable healthcare
providers to deliver critical information to patients, empowering
them to make decisions to improve and protect their health. For
more information on OraSure Technologies, please visit
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:
Ashley Buford
GolinHarris for OraSure Technologies
917-653-5694
abuford@golinharris.com
OraSure Technologies (NASDAQ:OSUR)
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