16.06.2008 19:38:00
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Nationwide Data Indicate a Very High Degree of Accuracy for OraQuick ADVANCE Rapid HIV-1/2 Antibody Test with Oral Fluid
OraSure Technologies, Inc. (NASDAQ:OSUR) today announced that aggregate
nationwide performance data for 2007 and the first five months of 2008
indicate that its widely used rapid HIV-1/2 antibody screening test,
OraQuick ADVANCE®,
has a very high degree of accuracy with oral fluid –
at rates that are within the U.S. Food and Drug Administration’s
approved and expected range of performance (specificity 99.6-99.9%) for
the product.
Based on aggregate data compiled by the Company from participating
surveillance sites nationwide for 2007 through May 2008, results for
over 250,000 oral fluid tests were reported with a specificity rate of
99.8%. The data was generated at more than 400 sites, including public
health clinics, community-based organizations, hospitals and outreach
settings.
"OraSure’s top
priority is and always has been to ensure that our customers are
satisfied with the performance of our products,”
said Douglas A. Michels, President and Chief Executive Officer of
OraSure Technologies. "We regularly monitor
the performance of the OraQuick ADVANCE® test on a national basis. The national data we have collected
from sites across the country confirms that OraQuick ADVANCE® with oral fluid performs at a very high accuracy level. We are
very pleased with the outstanding performance of OraQuick ADVANCE®,
which has proven to be an extremely valuable tool in the fight against
HIV/AIDS.”
OraQuick ADVANCE® is
a rapid screening test for antibodies to both HIV-1 and HIV-2, which can
be used at the point of care with oral fluid, finger stick and
venipuncture whole blood and plasma samples. All screening tests,
whether used at the point of care or in the laboratory, will generate a
certain percentage of false positive results. Consequently, all
specimens that test positive for HIV with a screening test must be
confirmed by additional testing using approved methods.
The performance data released represents a national average and, for any
point in time, may include some sites that report results slightly
outside of expected performance for a short period and then return to
normal levels. Such a situation recently occurred at the New York City
(NYC) Department of Health and Mental Hygiene’s
Sexually Transmitted Diseases (STD) branch, which reported a somewhat
elevated number of discordant test results from October 2007 through
April 2008 at some of its STD clinics.
The NYC STD clinic data shows a specificity of 2/10ths
of a percent below the lower end of the expected range of specificity
(99.6%). However, some of the NYC STD clinics demonstrated specificity
throughout this period that was within the expected range. Moreover,
national surveillance data during this same time period indicated the
test performed at 99.8% across the country (excluding the NYC STD
clinics) and specificity in the NYC STD clinics returned to 99.9% during
May 2008 with nearly 5,000 oral fluid tests performed. The NYC
Department of Health continues to use the OraQuick ADVANCE® test for HIV screening.
The Company is working with the NYC Department of Health and the Centers
for Disease Control and Prevention (CDC) to better understand the
performance at the STD clinic sites. This is consistent with the
procedures the Company follows whenever it receives a report of
discordant test results from one of its customers. It is important to
note that the oral fluid screening test is part of a multi-test
algorithm used by these STD clinics designed to prevent any patient
screened for HIV from leaving the clinic with an incorrect result.
"Oral Fluid testing continues to be a very
important component of HIV prevention in New York City and around the
nation,” Michels said. "Thanks
primarily to rapid HIV testing, health care providers have been able to
screen more people and ensure those diagnosed with HIV are linked into
care immediately.” 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.
OraSure Technologies is the leading supplier of oral-fluid collection
devices to the life insurance industry and public health markets for the
detection of antibodies to HIV. In addition, the Company supplies
oral-fluid testing solutions for drugs of abuse testing. For more
information on the Company, please go to www.orasure.com.
Important Information
This press release contains certain forward-looking statements,
including with respect to product performance and use. Actual results
could be significantly different. Factors that could affect results
include the ability to market and sell products; changes in
relationships, including disputes or disagreements, with strategic
partners 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; inventory levels at distributors and other customers; impact
of competitors, competing products and technology changes; 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; 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; 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 changes in international
funding sources; loss or impairment of sources of capital; ability to
meet financial covenants in agreements with financial institutions;
ability to retain qualified personnel; exposure to patent infringement,
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 complete consolidation or
restructuring activities; 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 Securities and Exchange Commission ("SEC”)
filings of OraSure Technologies, including its registration statements,
its Annual Report on Form 10-K for the year ended December 31, 2007, its
Quarterly Reports on Form 10-Q, and its other filings with the SEC.
Although forward-looking statements help to provide complete 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.
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