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OraSure Signs Commercialization Agreement With Roche

OraSure Technologies (OraSure ) and Roche Diagnostics (Roche) 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 Intercept device is the 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. The oral fluid assays use Roche’s KIMS (kinetic interaction of micro-particles in solution) technology and are being jointly developed under an agreement 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.

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 marketing capabilities.

Douglas Michels, president and CEO of OraSure, said: “We are 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.

“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.”