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March 3, 2011

FDA Grants 510(k) Approval to OraSure and Roche for Drug-of-Abuse Assays

  • FDA granted 510(k) clearance to OraSure Technologies and Roche for four homogeneous fully automated oral fluid assays developed to detect commonly abused drugs exclusively as part of OraSure’s Intercept® Oral Fluid Drug Testing System.

    FDA sanctioned assays for phencyclidine (PCP), cocaine, opiates, and methamphetamine. All four assays use Roche's KIMS (kinetic interaction of micro-particles in solution) technology and were jointly developed under an agreement previously signed by the companies.

    The assays are designed to run on various clinical chemistry automated analyzers, intended to allow oral fluid samples to be processed with the same efficiency as current fully automated urine-based drug tests.

    The companies say they anticipate the first four assays will be available for sale later this year. Several additional assays are also in development and are currently in varying stages of submission with the FDA.

    Intercept® is the only FDA-cleared in vitro diagnostic laboratory-based oral fluid testing system used for detecting commonly abused drugs that include marijuana, cocaine, opiates, PCP, and amphetamines (including methamphetamine and ecstasy), as well as barbiturates, methadone, and benzodiazepines.



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