OraSure Receives FDA Approval of OraQuick(R) In-Home HIV Test
July 03 2012 - 12:23PM
OraSure Technologies, Inc. (Nasdaq:OSUR) today announced that the
U.S. Food and Drug Administration (FDA) has approved the Company's
OraQuick® In-Home HIV Test for sale directly to consumers in the
over-the-counter (OTC) market – making it the first and only rapid
OTC HIV test approved in the U.S. The OraQuick® In-Home HIV Test
can detect antibodies to both HIV-1 and HIV-2 with an oral swab,
providing a confidential in-home testing option with results in as
little as 20 minutes. It is the first rapid diagnostic test for any
infectious disease that has been approved by the FDA for sale over
the counter.
"Approval of the OraQuick® In-Home HIV Test represents a major
breakthrough in HIV testing," said Douglas A. Michels, President
and Chief Executive Officer of OraSure Technologies. "For the first
time ever, individuals will have access to an in-home oral test
that will empower them to learn their HIV status in the comfort of
their home and obtain referral to care if needed. This new in-home
rapid test – the same test doctors have used for years – will help
individuals at risk for HIV who otherwise may not test in a
professional or clinical setting."
The OraQuick® In-Home HIV Test is an over-the-counter version of
the Company's OraQuick ADVANCE® HIV 1/2 Antibody Test, the market
leading rapid HIV test with millions of units sold to hospitals,
clinics, community-based organizations and physician offices.
The OraQuick® In-Home HIV Test is expected to be available for
purchase this October at more than 30,000 retail outlets throughout
the country and online.
OraSure is committed to providing OraQuick® In-Home HIV
customers with extensive resources and support. Each test kit
includes detailed information on HIV and HIV testing, including
step-by-step directions on how to use the OraQuick® In-Home HIV
Test. Customers also have access to a "live" toll-free customer
support center and comprehensive consumer website. The support
center is staffed with bi-lingual (English/Spanish) representatives
who are available by telephone (toll free 866-436-6527) to answer
questions about HIV/AIDS, describe how to use the test and
interpret the results, and to provide direct referral to care if
needed. Support center representatives are available 24 hours a
day, seven days a week, 365 days a year and will be active starting
on Monday, July 9th. In addition to the support center, a
comprehensive consumer website will be launched to provide access
to resources and referral to follow-up counseling and medical care.
The comprehensive website will launch when product is available in
October.
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. Those who do not know they are HIV positive are
disproportionately responsible for the 50,000 new HIV infections
that occur each year.
"We set out with a clear purpose – to dramatically impact the
number of people getting tested for HIV nationwide," added Michels.
"Today's FDA approval of OraQuick brings us much closer to
accomplishing that goal."
For information about the OraQuick In-Home HIV Test, visit
OraQuick.com.
About OraSure Technologies
OraSure Technologies is a leader in the development, manufacture
and distribution of oral fluid diagnostic and 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, the Company 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 and expected sales and product
availability. 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
integrate and realize the full benefits of the Company's
acquisition of DNA Genotek; ability to identify, complete,
integrate and realize the full benefits of future acquisitions;
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
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utilize net operating loss carry forwards or other deferred tax
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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, 2011, 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
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