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OraSure Technologies Receives FDA Clearance for Ninth Intercept Oral Fluid Drug Test
Friday, April 19, 2002
BETHLEHEM, Pa., Apr 19, 2002 (BW HealthWire) -- OraSure Technologies, Inc. (Nasdaq:OSUR),
the market leader in oral fluid diagnostics, today announced that it has received
510(k) clearance from the FDA for a test for detecting benzodiazepines in oral
fluid specimens, which will be available as part of the Company's Intercept®
laboratory-based drug testing service.
Benzodiazepines are a commonly prescribed class of tranquilizers and one of the
most frequently abused prescription drugs.
The Company previously received FDA clearance of its Intercept® drug tests
for screening oral fluid to detect opiates, cocaine, PCP, marijuana, methamphetamine,
amphetamine, barbiturates and methadone. This new test is an important addition
to the testing menu for Intercept®, and is commonly requested by the Company's
drug rehabilitation and criminal justice customers.
With the addition of the benzodiazepines test, the Company can now offer an
oral fluid laboratory-based test panel that is broad enough to fully compete
with most urine tests.
"This latest FDA clearance further strengthens our Intercept® product,"
said Mike Gausling, President and Chief Executive Officer of OraSure Technologies.
"With our expanded menu of oral fluid tests, we have enhanced our position
as the leading oral fluid diagnostics company, and are well positioned to further
penetrate the workplace, drug rehabilitation and criminal justice markets with
our laboratory-based Intercept® oral fluid drug testing service."
OraSure Technologies currently manufactures and markets Intercept®, the only
FDA-cleared, laboratory-based oral fluid drug test, and is in the process of
commercializing its UPlink™ point-of-care, oral fluid drug testing system.
The Company believes that its Intercept® and UPlink™ products will provide
a wide variety of oral fluid drug testing solutions for its customers in both
the workplace and criminal justice testing markets. The size of the domestic
market for drugs of abuse testing is estimated at approximately $1.5 billion,
involving more than 42 million specimens per year.
About OraSure Technologies
OraSure Technologies, Inc. is the market leader in oral fluid diagnostics.
The Company develops, manufactures and markets medical devices and diagnostic
products for use by insurance companies, public health agencies, clinical laboratories,
physicians' offices, and workplace sites. For more information on the Company
and its products, please visit www.orasure.com.
Important Information
This press release contains certain forward-looking statements, including with
respect to products, regulatory filings and clearances, markets and product
sales. 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 obtain and timing of obtaining necessary
regulatory approvals; ability to develop product distribution channels; uncertainty
relating to patent protection and potential patent infringement claims; 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; 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 inventory practices and consolidations; equipment failures
and ability to obtain needed raw materials and components; the impact of terrorist
attacks and civil unrest; and general business, political and economic conditions.
These and other factors are discussed more fully in the Securities and Exchange
Commission filings of OraSure Technologies, including its registration statements
and its Annual Report on Form 10-K for the year ended December 31, 2001. 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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