OraSure Technologies to Sell OraQuick ADVANCE Rapid HIV-1/2 Antibody Test Directly to U.S. Hospitals
06 11월 2008 - 6:00AM
Business Wire
OraSure Technologies, Inc. (NASDAQ:OSUR), a market leader in oral
fluid diagnostics, today announced that it will begin to sell its
OraQuick ADVANCE� Rapid HIV-1/2 Antibody Test directly into the
U.S. hospital market beginning in 2009. In recent years, the U.S.
hospital market has received this product through an exclusive
distribution arrangement with Abbott. In early 2005, OraSure and
Abbott entered into an agreement under which Abbott has distributed
OraQuick ADVANCE� on an exclusive basis to U.S. hospitals and
reference laboratories and on a non-exclusive basis to the U.S.
physician office market. Pursuant to a transition agreement
recently executed by the parties, the distribution agreement will
terminate effective as of the end of 2008. Abbott and OraSure will
work to implement a transition of this business directly to
OraSure. In anticipation of the transition, OraSure has started to
increase the size of its hospital sales force along with inside
sales, customer service and sales support resources. The direct
sales force will be responsible for selling OraQuick ADVANCE� to
U.S. hospital customers along with other future products, including
the OraQuick� Hepatitis C test recently submitted to the FDA for
pre-market approval. The U.S. physician office market will continue
to be served through distributors. �We have enjoyed a successful
relationship with Abbott and appreciate all of Abbott�s efforts to
build our OraQuick ADVANCE� business in the U.S. hospital market,�
said Douglas A. Michels, President and CEO of OraSure Technologies.
�Beginning in 2009, OraSure will sell OraQuick ADVANCE� directly to
the U.S. hospital and reference laboratory markets. Our hospital
business is extremely important and we anticipate continued growth
in this market with both current and future products. We are eager
to continue the development of even closer relationships with our
hospital customers.� The transition will result in incremental
expense related to sales force recruitment, infrastructure
expansion and payment of a termination fee to Abbott pursuant to
the transition agreement. In addition, OraSure sales to Abbott in
the fourth quarter of 2008 are expected to be somewhat lower than
normal as Abbott reduces its inventory level of OraQuick ADVANCE�
as part of the transition. Additional information regarding the
transition will be provided during the Company�s third quarter
earnings call scheduled for 5:00 p.m. EST (2:00 p.m. PST) today.
OraQuick ADVANCE� is the only rapid, point-of-care test for the
detection of antibodies to both HIV-1 and HIV-2 within twenty
minutes that is 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 commercially launched the
OraQuick ADVANCE� test in October 2004. 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 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
markets, product sales and distribution, sales personnel, expenses
and revenues. 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; impact of replacing
distributors; inventory levels at distributors and other customers;
impact of replacing distributors; 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 the Company�s 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 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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