OraSure Technologies Receives FDA Approval for OraQuick(R) HCV Rapid Test, the First Rapid HCV Test Approved for Sale in the U.S
25 6월 2010 - 11:35PM
OraSure Technologies, Inc. (Nasdaq:OSUR) announced today that its
OraQuick® Hepatitis C ("HCV") Rapid Antibody Test has been approved
by the U.S. Food and Drug Administration ("FDA") for use in
detecting HCV antibodies in venous whole blood specimens, making it
the first rapid HCV test approved by the FDA for use in the United
States.
"The OraQuick HCV test efficiently identifies previously
undiagnosed HCV infected individuals who are at risk," said Eugene
R. Schiff, MD, MACP, FRCP, MACG, AGAF, University of Miami School
of Medicine. "We at the University of Miami found this test to be
user-friendly, practical and an important tool for rapid HCV
antibody detection."
"We believe that the OraQuick® HCV Rapid Antibody Test, with its
simplicity and speed, will be a critical tool in identifying more
at risk individuals infected with hepatitis C in the U.S., and thus
represents a significant market opportunity," said Douglas A.
Michels, President and Chief Executive Officer of OraSure
Technologies. "Obtaining FDA approval of our OraQuick® HCV Rapid
Antibody Test for venous whole blood represents a major milestone
for our Company."
OraQuick® HCV is the only rapid, point-of-care test for the
detection of antibodies to the hepatitis C virus in venous whole
blood specimens that is approved by the FDA. The test, which
utilizes the OraQuick® technology platform, provides results in 20
minutes. The OraQuick® HCV Rapid Antibody Test is the latest rapid
test manufactured by OraSure to receive FDA approval. OraSure had
previously received FDA approval for its OraQuick ADVANCE® Rapid
HIV-1/2 Antibody Test for use with oral fluid, fingerstick and
venous whole blood and plasma samples.
In the U.S., there are an estimated 4.1 million Americans, or
1.6 percent of the population, that are or have been infected with
HCV. According to the Centers for Disease Control and Prevention
("CDC"), new infections in the U.S. are estimated at approximately
20,000 per year. On a worldwide basis, there are an estimated 180
million people who are chronically infected with HCV, with an
estimated 3 to 4 million individuals newly infected each year.
According to the World Health Organization, most cases of HCV
infection are currently undiagnosed and up to 80 percent of
HCV-positive individuals show no signs or symptoms.
In December 2009, the Company received the CE mark for its
OraQuick HCV Rapid Antibody Test for use with oral fluid, whole
blood, serum and plasma specimens. The CE mark was required in
order to sell the product in the European Union.
As previously announced, OraSure has entered into agreements
with Merck & Co. (through its predecessor Schering Plough
Corporation) to collaborate on the development and promotion of the
OraQuick® HCV test. Under the terms of these agreements, the
Company has been and will be reimbursed by Merck for a portion of
its costs to develop the test and obtain regulatory approvals.
Additionally, Merck will provide promotional support, including
detailing the test in the physicians' office market in those
countries in which the Company has obtained approval.
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
testing solutions for drugs of abuse and for the detection of
antibodies to HIV.
For more information on the Company, please go to
www.orasure.com.
The OraSure Technologies, Inc. logo is available at
http://www.globenewswire.com/newsroom/prs/?pkgid=6440
Important Information
This press release contains certain forward-looking statements,
including with respect to product sales and
registrations. Forward-looking statements are not guarantees
of future performance or results. Known and unknown factors that
could cause actual performance or results to be materially
different from those expressed or implied in these statements
include, but are not limited to: ability to market and sell
products, whether through an internal, direct sales force or third
parties; ability to manufacture products in accordance with
applicable specifications, performance standards and quality
requirements; changes in relationships, including disputes or
disagreements, with strategic partners or other parties 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 and success of direct sales efforts;
inventory levels at distributors and other customers; impact of
competitors, competing products and technology changes; impact of
the economic downturn, high unemployment and poor credit
conditions; reduction or deferral of public funding available to
customers; competition from new or better technology or lower cost
products; 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, extended shelf life or other factors; 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; ability to utilize net operating loss carry forwards
or other deferred tax assets; 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 the impact of 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
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
Company's Securities and Exchange Commission filings,
including its registration statements, Annual Report on Form 10-K
for the year ended December 31, 2009, Quarterly Reports on Form
10-Q, and other filings with the SEC. Although forward-looking
statements help to provide 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 Note and OraSure Technologies undertakes no duty to update
these statements.
CONTACT: OraSure Technologies, Inc.
Investor Contact:
Ronald H. Spair, Chief Financial Officer
610-882-1820
investorinfo@orasure.com
Zer0 to 5ive for OraSure Technologies
Media Contact:
Jennifer Moritz
917-748-4006
jmoritz@0to5.com
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