OraSure and Roche in Worldwide Commercialization Agreement for Drugs of Abuse Assays

(Bethlehem, PA, USA) and Roche Diagnostics (Basel, Switzerland) 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 are intended to allow oral fluid samples to be processed with the same effectiveness 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 company'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 U.S. Food and Drug Demonstration (FDA)-cleared in vitro diagnostic laboratory-based oral fluid testing system used for detecting typically 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.

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

Roche is a leader in research-focused healthcare with combined strengths in pharmaceuticals and diagnostics. Roche is the world's largest biotech company with differentiated medicines in oncology, virology, inflammation, metabolism, and central nervous system (CNS). Roche is also the world leader in in-vitro diagnostics and tissue-based cancer diagnostics and a pioneer in diabetes management.

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