OraSure Technologies, Inc. has entered an agreement with Thermo Fisher Scientific to develop and supply as many as 12 homogenous fully automated oral fluid drugs of abuse assays for use with a new Intercept oral fluid specimen collection device. OraSure will have the right to purchase and resell the assays in the U.S. and certain other countries, subject to applicable regulatory approvals.
The companies anticipate selling NIDA-5 panel assays with the next generation Intercept device in the domestic criminal justice and forensics markets beginning in 2H14, and expect to complete development of several more assays and obtain FDA 510(k) clearance and approvals in certain foreign countries. The assays will be optimized to comply with new oral fluid guidelines expected to be issued by the Substance Abuse and Mental Health Services Administration (SAMHSA) for the federally regulated market and certain other markets that follow Federal drug testing guidelines.
In conjunction with the new agreement, OraSure has terminated its assay collaboration agreement with Roche Diagnostics. However, certain assays developed under that collaboration will remain available on a transitional basis for use with OraSure's existing Intercept collection device.
"The new agreement with Thermo Fisher is an important strategic development for our Substance Abuse Testing business," said Douglas A. Michels, president and chief executive officer of OraSure Technologies. "Combined with our new Intercept collector, we look forward to adding a complete menu of fully automated oral fluid drug assays to our customer offerings beginning in 2014."