OraSure, Roche Diagnostics Seal Commercialisation Agreement

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 analysers, which is intended to allow oral fluid samples to be processed with the same efficiency as current fully automated urine-based drug tests.

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

The company claims that 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, and for detecting barbiturates, methadone and benzodiazepines.

Douglas Michels, president and CEO of OraSure, said: “We are very pleased with our joint development effort with Roche and the finalisation and execution of the commercialisation agreement associated with these important drugs of abuse assays. 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.”

Dirk Ehlers, head of professional diagnostics at Roche, said: “We are very pleased to be collaborating with OraSure Technologies in the development and commercialization of fully automated oral fluid drugs of abuse assays. 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.”