OraSure Technologies Announces New Agreement With Thermo Fisher Scientific for Development and Distribution of Fully Automated

OraSure Technologies Announces New Agreement With Thermo Fisher Scientific for
Development and Distribution of Fully Automated Oral Fluid Drugs of Abuse

OraSure Transitions From Prior Oral Fluid Assay Collaboration

BETHLEHEM, Pa., Nov. 21, 2013 (GLOBE NEWSWIRE) -- OraSure Technologies, Inc.
(Nasdaq:OSUR) announced today that it has reached an agreement with Thermo
Fisher Scientific (Thermo Fisher), to develop and supply up to 12 homogenous
fully automated oral fluid drugs of abuse assays to be used with a new
Intercept^® oral fluid specimen collection device. OraSure will have the right
to purchase and resell the assays in the U.S. and in certain foreign
countries, subject to receipt of applicable regulatory approvals.

OraSure also announced today
that although its prior assay collaboration agreement has been terminated,
certain assays developed under that collaboration will remain available on a
transitional basis for use with OraSure's existing Intercept^® collection

Under this new agreement with Thermo Fisher, a NIDA-5 panel of assays is
expected to be initially sold with the next generation Intercept device in the
domestic criminal justice and forensics markets beginning in the second half
of 2014. Eventually, the parties expect to complete development of several
more assays and obtain FDA 510(k) clearance and approvals in certain foreign
countries. The assays will be optimized as needed to comply with new oral
fluid guidelines expected to be issued by the Substance Abuse and Mental
Health Services Administration (SAMHSA) for the federally regulated market and
certain other markets that follow Federal drug testing guidelines, none of
which are currently served by OraSure.

The new agreement will enable OraSure to provide its customers with a
comprehensive menu of automated oral fluid assays that can be used by
laboratories on their established base of clinical chemistry automated
analyzers, allowing oral fluid samples to be processed with the same
efficiency as current fully automated urine-based drug tests.These assays
will be used with OraSure's new Intercept^® collector (expected to be
available in 2014), which features a volume indicator that activates when a
1mL sample of oral fluid has been collected. This new feature is expected to
meet anticipated new SAMHSA oral fluid drug testing guidelines and better
serve the future needs of OraSure's drug testing customers.

"The new agreement with Thermo Fisher is an important strategic development
for our Substance Abuse Testing business," said Douglas A. Michels, President
and Chief Executive Officer of OraSure Technologies. "Combined with our new
Intercept^® collector, we look forward to adding a complete menu of fully
automated oral fluid drug assays to our customer offerings beginning in 2014."

OraSure's current Intercept^® Oral Fluid Drug Testing Systemwas the first
FDA-cleared in-vitro diagnostic laboratory-based oral fluid drug testing
system, and is the only one that is FDA cleared for detection of nine commonly
abused drugs, including marijuana, cocaine, opiates, PCP, amphetamines,
methamphetamine, barbiturates, methadone and benzodiazepines. It combines the
ease, efficiency, and cost savings of oral fluid collection with significantly
increased sample integrity and the accuracy of lab-reliable, proven results.

The Intercept^® Oral Fluid Drug Testing System is primarily being used in the
workplace, drug treatment and criminal justice drug testing markets.To learn
more about the OraSure's Substance Abuse Testing products, please visit

About OraSure Technologies

OraSure Technologies is a leader in the development, manufacture and
distribution of oral fluid diagnostic and collection devices and other
technologies designed to detect or diagnose critical medical conditions. Its
innovative products include rapid tests for the detection of antibodies to HIV
and HCV at the point of care and testing solutions for detecting various drugs
of abuse. In July 2012, the Company received approval from the U.S. Food and
Drug Administration for the Company's OraQuick^® In-Home HIV Test for sale
directly to consumers in the over-the-counter (OTC) market - making it the
first and only rapid OTC HIV test approved in the U.S. In addition, the
Company is a leading provider of oral fluid sample collection, stabilization
and preparation products for molecular diagnostic applications. OraSure's
portfolio of products is sold globally to various clinical laboratories,
hospitals, clinics, community-based organizations and other public health
organizations, research and academic institutions, distributors, government
agencies, physicians' offices, and commercial and industrial entities. The
Company's products enable healthcare providers to deliver critical information
to patients, empowering them to make decisions to improve and protect their

For more information on OraSure Technologies, please visit www.orasure.com.

Important Information

This press release contains certain forward-looking statements, including with
respect to product development and availability, sales and regulatory
approvals and clearances. 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; 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; 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; inventory levels at distributors
and other customers; ability to integrate and realize the full benefits of the
Company's acquisition of DNA Genotek; ability of DNA Genotek to achieve its
financial and strategic objectives; ability to identify, complete, integrate
and realize the full benefits of future acquisitions; 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,including the OraQuick^® In-Home HIV test; 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; 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 products and components; availability of
related products produced by third parties or products required for use of our
products; 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 and testing
algorithms; adverse movements in foreign currency exchange rates; loss or
impairment of sources of capital;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;
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, 2012, 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 press release and OraSure
Technologies undertakes no duty to update these statements.

CONTACT: Investor Contact:
         Ron Spair
         OraSure Technologies
         Media Contact:
         Jennifer Moritz
         Zer0 to 5ive for OraSure Technologies

company logo
Press spacebar to pause and continue. Press esc to stop.