Nationwide Data Indicate a Very High Degree of Accuracy for OraQuick ADVANCE Rapid HIV-1/2 Antibody Test with Oral Fluid
16 Giugno 2008 - 9:38PM
Business Wire
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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