OraSure Technologies and Roche have received the US Food and Drug Administration (FDA) 510(k) clearance on four homogeneous fully automated oral fluid drugs of abuse assays developed to be used exclusively as part of OraSure's Intercept Oral Fluid Drug Testing System.
OraSure Technologies‘ Intercept Drug Testing System 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.
The cleared oral fluid assays include Phencyclidine (PCP), Cocaine, Opiates and Methamphetamine.
The oral fluid assays use Roche‘s KIMS (kinetic interaction of micro-particles in solution) technology and were jointly developed under an agreement previously signed by the parties.
The 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 efficiency as current fully automated urine-based drug tests.
Intercept is primarily used in workplace, drug treatment and criminal justice testing markets, as well as in public school systems.