Healthcare Industry News:  Roche  

Diagnostics

 News Release - January 19, 2010

OraSure Technologies and Roche Diagnostics Sign Worldwide Commercialization Agreement for Fully Automated Oral Fluid Drugs of Abuse Assays

BETHLEHEM, Pa., Jan. 19, 2010 -- (Healthcare Sales & Marketing Network) -- OraSure Technologies, Inc. (Nasdaq:OSUR ) and Roche Diagnostics today announced that the companies have signed an agreement for the worldwide commercialization of homogeneous fully automated oral fluid drugs of abuse assays with OraSure’s Intercept® oral specimen collection device. The oral fluid assays use Roche’s KIMS (kinetic interaction of micro-particles in solution) technology and are being jointly developed under an agreement previously signed by the parties. The oral fluid assays are designed to run on various clinical chemistry automated analyzers, which is intended to allow oral fluid samples to be processed with the same efficiency as current fully automated urine-based drug tests.

“We are very pleased with our joint development effort with Roche and the finalization and execution of the commercialization agreement associated with these important drugs of abuse assays. This relationship leverages Roche’s industry leadership in lab instrumentation and reagent chemistry and our leadership in oral fluid technology and sample collection devices,” said Douglas A. Michels, President and CEO of OraSure Technologies. “We look forward to working with Roche to bring these new assays to market where they will have an immediate and positive impact on laboratory efficiency for drugs of abuse testing.”

“We are very pleased to be collaborating with OraSure Technologies in the development and commercialization of fully automated oral fluid drugs of abuse assays,” said Dirk Ehlers, Head of Roche Professional Diagnostics. “This partnership leverages the strengths and experience of both companies and will enable us to deliver on our global commitment to providing best-in-class high throughput oral fluid drug testing solutions.”

The commercialization agreement is structured to take advantage of each party’s respective distribution strengths, including OraSure’s established market presence with oral fluid testing and Roche’s established base of analyzers and broad marketing capabilities.

Developed and manufactured by OraSure Technologies, the Intercept® device is the only FDA-cleared in vitro diagnostic laboratory-based oral fluid testing system used for detecting commonly abused drugs such as marijuana, cocaine, opiates, PCP and amphetamines (including methamphetamine and ecstasy) and for detecting barbiturates, methadone and benzodiazepines. Intercept® is currently being used in workplace, drug treatment and criminal justice testing markets, as well as in public school systems.

A global leader in diagnostics, Roche has been providing testing solutions for the drugs of abuse market for more than 25 years. Roche offers a broad test menu, integrated analyzer platforms and automation solutions to help a wide variety of labs increase revenue, improve efficiency and enhance patient care.

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.

About Roche

Headquartered in Basel, Switzerland, Roche is a leader in research-focused healthcare with combined strengths in pharmaceuticals and diagnostics. Roche is the world’s largest biotech company with truly differentiated medicines in oncology, virology, inflammation, metabolism and CNS. Roche is also the world leader in in-vitro diagnostics and tissue-based cancer diagnostics and a pioneer in diabetes management. Roche’s personalized healthcare strategy aims at providing medicines and diagnostic tools that enable tangible improvements in the health, quality of life and survival of patients. In 2008, Roche had over 80,000 employees worldwide and invested almost 9 billion Swiss francs in R&D. The Group posted sales of 45.6 billion Swiss francs. Genentech, United States, is a wholly owned member of the Roche Group. Roche has a majority stake in Chugai Pharmaceutical, Japan. For more information: www.roche.com or www.roche-diagnostics.us.

Important Information

This press release contains certain forward-looking statements, including with respect to products and their commercialization in certain markets. Actual results could be significantly different. Factors that could affect results include the 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 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 credit crisis; 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 and extended shelf life; 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 and ability to utilize net operating loss carry forwards or other deferred tax assets; volatility of the Company’s 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 (“SEC”) filings of OraSure Technologies, including its registration statements, its Annual Report on Form 10-K for the year ended December 31, 2008, 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.


Source: OraSure Technologies

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