OraSure Technologies Files For FDA Approval of OraQuick Rapid Hepatitis C Test
28 10์ 2008 - 7:00PM
Business Wire
OraSure Technologies, Inc. (NASDAQ:OSUR) today announced that it
has submitted a pre-market approval (๏ฟฝPMA๏ฟฝ) application to the U.S.
Food and Drug Administration (๏ฟฝFDA๏ฟฝ) for a rapid test for
antibodies to the Hepatitis C virus (๏ฟฝHCV๏ฟฝ) utilizing OraSure
Technologies๏ฟฝ OraQuick๏ฟฝ technology platform. When approved, the
OraQuick๏ฟฝ HCV test is expected to be the first rapid HCV test
approved by the FDA for use in the United States. The Company is
seeking FDA approval for use of its OraQuick๏ฟฝ HCV test on five
specimen types - oral fluid, fingerstick whole blood, venous whole
blood, plasma and serum. The submission reflects the successful
completion of clinical studies which include data from over 3,000
subjects. The Company also intends to submit a request for CE mark
approval of the OraQuick๏ฟฝ HCV test within the next several months.
CE mark approval is needed to sell the test in the European Union.
๏ฟฝThe completion of our FDA submission for the OraQuick๏ฟฝ HCV test is
the result of a tremendous effort by our regulatory, research and
development and operations groups, and we are very grateful for all
of their efforts,๏ฟฝ said Douglas A. Michels, President and CEO of
OraSure Technologies. ๏ฟฝWe believe the market opportunity for a
rapid HCV test, both here in the U.S. and around the world, is very
significant and this submission represents the achievement of an
important milestone towards commercialization. We look forward to
launching this product in the U.S. in collaboration with
Schering-Plough Corporation once FDA approval is obtained.๏ฟฝ On a
world-wide basis, there are an estimated 180 million people who are
chronically infected with HCV, with an estimated three to four
million individuals newly infected each year. The prevalence of
Hepatitis C infection is estimated to be four times that of HIV
around the world. According to the World Health Organization, as
many as fifty percent of persons infected with HCV are undiagnosed
and up to eighty percent who have HCV show no signs or symptoms. In
the U.S., there are an estimated four million Americans, or 1.3
percent of the population, that are or have been infected with HCV.
According to the Centers for Disease Control and Prevention
(๏ฟฝCDC๏ฟฝ), new infections in the U.S. are estimated at approximately
20,000 per year. As previously announced, OraSure has entered into
agreements with Schering-Plough Corporation to collaborate on the
development and promotion of the OraQuick๏ฟฝ HCV test. Under the
terms of these agreements, the Company has been and will be
reimbursed by Schering-Plough for a portion of its costs to develop
the test and obtain regulatory approvals, and Schering-Plough will
provide detailing and other promotional support for the test in the
physicians๏ฟฝ office markets in the United States and
internationally. About Hepatitis C Hepatitis C is the major cause
of acute Hepatitis and chronic liver disease and, if left
undiagnosed and treated, can lead to cirrhosis of the liver, liver
cancer, liver failure and death. According to the CDC it is
estimated that seventy-five to eighty-five percent of those people
who become infected with the hepatitis C virus develop chronic
infection, and five to twenty percent eventually develop cirrhosis
of the liver. Although HCV is a significant health issue, it is a
curable disease. With current treatment therapies, the rates of
sustained viral clearance are as high as fifty percent in cases of
infection by Genotype 1, the most common form of HCV, and as high
as eighty percent with the less commonly occurring Genotypes 2 and
3 of the virus. New therapies are under development which may
improve these treatment rates. OraSure believes the key to
improving public health with respect to this disease is early
diagnosis through wide-spread testing. 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๏ฟฝ
offices, and commercial and industrial entities. OraSure
Technologies is the leading supplier of oral-fluid collection
devices and assays to the public health and life insurance 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 products,
testing and regulatory submissions and approvals. 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๏ฟฝs 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๏ฟฝs 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 (๏ฟฝSEC๏ฟฝ) 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.
OraSure Technologies (NASDAQ:OSUR)
๊ณผ๊ฑฐ ๋ฐ์ดํฐ ์ฃผ์ ์ฐจํธ
๋ถํฐ 6์(6) 2024 ์ผ๋ก 7์(7) 2024
OraSure Technologies (NASDAQ:OSUR)
๊ณผ๊ฑฐ ๋ฐ์ดํฐ ์ฃผ์ ์ฐจํธ
๋ถํฐ 7์(7) 2023 ์ผ๋ก 7์(7) 2024