Novation Signs Single Source Agreement for OraQuick(R) ADVANCE(TM) Rapid HIV-1/2 Antibody Test
19 Aprile 2006 - 12:00PM
Business Wire
OraSure Technologies, Inc. (NASDAQ: OSUR) today announced that
Novation, the health care contracting services company of VHA,
Inc., a health care provider alliance of more than 2,400
not-for-profit health care organizations, and the University
HealthSystem Consortium (UHC), has signed an agreement with Abbott
Laboratories to make the OraQuick(R) ADVANCE(TM) Rapid HIV-1/2
Antibody Test available throughout Novation's network of healthcare
facilities. The Novation healthcare network includes nearly 3,000
members. Abbott Laboratories, the Company's exclusive distributor
of the OraQuick(R) ADVANCE(TM) HIV-1/2 test to hospitals in the
U.S., has signed a single-source new technology agreement with
Novation. The contract began on April 1, 2006 and will run through
March 31, 2009. Providing results in as little as 20 minutes,
OraQuick(R) ADVANCE(TM) is the only rapid, point-of-care test for
the detection of antibodies to both HIV-1 and HIV-2 approved by the
U.S. Food and Drug Administration (FDA) for use on oral fluid,
finger stick or venipuncture whole blood, and plasma specimens. The
test is also CLIA (Clinical Laboratory Improvements Amendments Act
of 1988) waived for all specimen types except plasma. OraSure
Technologies commercially launched the OraQuick(R) ADVANCE(TM) test
in October 2004. "This agreement should expand the use of
OraQuick(R) ADVANCE(TM) in VHA and UHC hospitals, providing these
facilities with the most flexible, accurate rapid HIV-1/2 test
available," said Douglas A. Michels, President and CEO of OraSure
Technologies. "We look forward to working with Abbott and Novation
to make the OraQuick(R) ADVANCE(TM) test available as a valuable
tool in the fight against HIV/AIDS - particularly in hospital
emergency departments and labor and delivery settings." The U.S.
Centers for Disease Control and Prevention (CDC) issued draft
guidelines in 2005 that urged healthcare professionals to increase
HIV testing among age-appropriate patients in hospital emergency
departments and pregnant women whose HIV status is unknown. The CDC
reported that conducting HIV screening on presenting mothers could
result in virtually eliminating all mother-to-infant disease
transmission among those found to be preliminarily positive and
treated prior to delivery. 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 and assays to the life insurance
industry and public health markets for the detection of 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 distribution, use and sales. Actual results could be
significantly different. Factors that could affect results include
the ability to market products; impact of competitors, competing
products and technology changes; ability to develop, commercialize
and market new products; market acceptance of oral fluid testing
products and other new products or technology; ability to fund
research and development and other projects 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; ability to obtain, and timing of obtaining, necessary
regulatory approvals; 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; loss or
impairment of sources of capital; ability to meet financial
covenants in agreements with financial institutions; ability to
retain qualified personnel; exposure to product liability, patent
infringement, and other types of litigation; changes in
international, federal or state laws and regulations; changes in
relationships with strategic partners and reliance on strategic
partners for the performance of critical activities under
collaborative arrangements; 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, 2005,
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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