OraSure Technologies Submits CLIA Waiver Application for OraQuick(R) HCV Rapid Test
23 Marzo 2011 - 11:00AM
OraSure Technologies, Inc. (Nasdaq:OSUR) announced today that it
has submitted to the U.S. Food and Drug Administration ("FDA") an
application for a waiver under the Clinical Laboratory Improvement
Amendments of 1988 ("CLIA") for its OraQuick® HCV Rapid Antibody
Test for use with venous whole blood and fingerstick whole blood
specimens.
The OraQuick® HCV Rapid Antibody Test is the
first and only FDA-approved rapid test for the detection of
antibodies to the hepatitis C virus and is currently classified as
a moderately complex test which can be used by approximately 40,000
laboratories certified as meeting certain quality and training
requirements under CLIA. According to the Centers for Medicaid and
Medicare Services, if the CLIA waiver application is approved, the
OraQuick® HCV test could then be available for use
by more than 180,000 sites nationwide, including those that can
perform CLIA-waived tests such as outreach clinics, community-based
organizations and physician offices.
"If approved, a CLIA waiver would enable greater access to a
test that could play a vital role in identifying HCV infection in
the United States," said Douglas A. Michels, President and Chief
Executive Officer of OraSure Technologies. "Most importantly, the
CLIA waiver will enable healthcare providers, those on the front
lines of fighting this disease, to identify more individuals
infected with hepatitis C and connect them to care and
treatment."
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.
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 approvals and
use. 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, 2010, 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: Investor Contact:
Ronald H. Spair
Chief Financial Officer
610-882-1820
investorinfo@orasure.com
Media Contact:
Jennifer Moritz
Zer0 to 5ive for OraSure Technologies
917-748-4006
jmoritz@0to5.com
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