BETHLEHEM, Pa.--(BUSINESS WIRE)--Aug. 2, 2005--OraSure
Technologies, Inc. (NASDAQ:OSUR), the market leader in oral fluid
diagnostics, announced today that it has received a worldwide,
non-exclusive license from Ortho-Clinical Diagnostics and Chiron
Corporation to patents relating to the hepatitis C ("HCV") virus.
Under the terms of the license, OraSure has obtained non-exclusive
rights to certain HCV patents from Ortho-Clinical Diagnostics and
Chiron Corporation, in exchange for the payments of upfront fees and
ongoing royalties on product sales.
The license will permit OraSure to manufacture, distribute and
sell a rapid, point-of-care diagnostic product to detect antibodies to
HCV in both oral fluid and blood. There currently is no U.S. Food and
Drug Administration ("FDA") approved rapid HCV test in the United
States, and there is no rapid HCV test available anywhere in the world
that can be used on oral fluid.
"Securing this HCV license gives us the opportunity to pursue and
develop a rapid test for hepatitis C, one of the most common chronic
bloodborne viral infections in the U.S. and abroad, and one that is
seen frequently in patients who also have HIV," said Douglas A.
Michels, President and CEO of OraSure Technologies. "Our goal has
always been to create the most versatile and comprehensive
point-of-care rapid tests in the world, and this license will enable
us to expand our product offerings to include HCV diagnostics."
First identified by Chiron scientists in 1987, HCV is the
causative agent for what was formerly known as non-A non-B hepatitis.
HCV is a major cause of acute hepatitis and chronic liver disease,
including cirrhosis and liver cancer. There is no known vaccine to
prevent HCV.
Globally, an estimated 170 million persons, or 3 percent of the
world's population, are chronically infected with HCV and three to
four million people are newly infected each year, according to the
World Health Organization.
OraSure, the market leader in oral fluid diagnostics, launched the
OraQuick(R) ADVANCE(TM) Rapid HIV-1/2 Antibody Test in October 2004,
the first and only FDA-approved and CLIA (Clinical Laboratory
Improvements Amendments Act of 1988) waived rapid, point-of-care test
that can detect antibodies to both HIV-1 and HIV-2 in 20 minutes,
using oral fluid, finger-stick or venipuncture whole blood and plasma
specimens. OraSure believes that its OraQuick(R) platform may be used
for the diagnosis of other infectious diseases, including HCV.
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
http://www.orasure.com.
Important Information About OraSure Technologies
This press release contains certain forward-looking statements,
including with respect to products, sales and markets. 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 up-converting phosphor technology products;
ability to fund research and development and other projects and
operations; ability to 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; ability to
obtain 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
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; changes in
accounting practices or interpretation of accounting requirements;
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, 2004, 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.
CONTACT: OraSure Technologies, Inc.
Investor Contact:
Ronald H. Spair, 610-882-1820
Investorinfo@orasure.com
www.orasure.com
or
Media Contacts:
Ron Ticho, 610-882-1820
rticho@orasure.com
or
Jennifer Moritz, 718-623-0355
jmoritz@0to5.com
SOURCE: OraSure Technologies, Inc.