Healthcare Industry News:  Roche Diagnostics 


 News Release - October 4, 2006

Roche Diagnostics and OraSure Technologies Sign Letter of Intent to Develop Fully Automated Oral Fluid Drugs of Abuse Assays

This partnership will enable laboratories to increase efficiencies while offering an improved level of service by providing quicker turnaround times

INDIANAPOLIS, Oct. 4 (HSMN NewsFeed) -- Roche Diagnostics today signed a letter of intent to negotiate an agreement for the joint development and commercialization of homogeneous fully-automated oral fluid drugs of abuse assays that can run on random access chemistry analyzers with OraSure Technologies, Inc. (Nasdaq: OSUR ). The oral fluid assays will be developed for use with OraSure's Intercept® oral specimen collection device and Roche's KIMS (kinetic interaction of microparticles in solution) technology. The oral fluid assays will be designed to run on various automated analyzers and to allow oral fluid samples to be processed with the same efficiency as current urine based tests. Among the key potential benefits to laboratories will be increased efficiencies and quicker turnaround times.

"With automation of oral fluid testing becoming increasingly important, Roche is committed to providing best-in-class high throughput oral fluid solutions for our customers. We are very pleased to be collaborating with OraSure Technologies in the development of fully automated oral fluid drugs of abuse assays," said Joe Passarelli, Vice President of Research and Development at Roche Diagnostics. "This partnership would leverage the strengths of both companies including OraSure's market leading Intercept® Drug Test and Roche Diagnostics' fully automated ONLINE DAT® drug screening portfolio -- leading to an integrated product offering from a single source," he added.

"The development of automated assays for oral fluid drugs of abuse testing is technologically a very important step for OraSure and its laboratory customers," said Stephen R. Lee, Ph.D., Executive Vice President and Chief Science Officer, OraSure Technologies. "It will enable them to run these assays on the most advanced, flexible chemistry analyzers used in laboratories today, which should ultimately lead to higher volumes of oral fluid testing. We are extremely excited to be working with Roche on this project -- their industry-leading KIMS technology combined with their system reliability is ideally suited for this application," said Lee.

Developed and manufactured by OraSure Technologies, the Intercept® device is the only FDA-cleared invitro 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® testing is currently being used in workplace, drug treatment and criminal justice testing markets, as well as in public school systems.

With over twenty-five years of proven experience in the drugs of abuse market, Roche Diagnostics has established itself as a global leader. Roche offers a full portfolio of testing solutions including ONLINE DAT® drugs of abuse screening assays combined with system platforms that are tailored for various customer segment and volume requirements.

About Roche

Headquartered in Basel, Switzerland, Roche is one of the world's leading research-focused healthcare groups in the fields of pharmaceuticals and diagnostics. As a supplier of innovative products and services for the early detection, prevention, diagnosis and treatment of disease, the Group contributes on a broad range of fronts to improving people's health and quality of life. Roche is a world leader in diagnostics, the leading supplier of medicines for cancer and transplantation and a market leader in virology. In 2005, sales by the Pharmaceuticals Division totaled 27.3 billion Swiss francs, and the Diagnostics Division posted sales of 8.2 billion Swiss francs. Roche employs roughly 70,000 people in 150 countries and has R&D agreements and strategic alliances with numerous partners, including majority ownership interests in Genentech and Chugai. Roche's Diagnostics Division offers a uniquely broad product portfolio and supplies a wide array of innovative testing products and services to researchers, physicians, patients, hospitals and laboratories world-wide. Roche Centralized Diagnostics, a business area of Roche Diagnostics, is a leading force in developing and supplying new technologies and integrated solutions that help clinical laboratories to operate efficiently and cost effectively. For further information, please visit our website at .

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 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.

OraSure Technologies manufactures and sells Intercept®, the only FDA-cleared in vitro diagnostic 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. For more information on the Company, please go to .

Source: Roche Diagnostics

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