OraSure, Thermo Fisher To Develop Automated Oral Fluid Drugs Of Abuse Assays

(RTTNews) - OraSure Technologies, Inc. (OSUR) reported signing an agreement with Thermo Fisher Scientific (TMO), to develop and supply up to 12 homogenous fully automated oral fluid drugs of abuse assays to be used with a new Intercept oral fluid specimen collection device. OraSure would have the right to purchase and resell the assays in the U.S. and in certain foreign countries.

In addition, OraSure announced that though its prior assay collaboration deal has been terminated, certain assays developed under that collaboration would remain available on a transitional basis for use with OraSure's existing Intercept collection device.

As part of the new agreement with Thermo Fisher, a NIDA-5 panel of assays is likely to be initially sold with the next generation Intercept device in the domestic criminal justice and forensics markets beginning in the 2014 second half. The parties anticipate to complete development of several more assays and obtain FDA 510(k) clearance and approvals in certain foreign countries. The assays would be optimized as needed to comply with new oral fluid guidelines expected to be issued by the Substance Abuse and Mental Health Services Administration or SAMHSA for the federally regulated market and certain other markets that follow Federal drug testing guidelines, none of which are presently served by OraSure.

OraSure Technologies' President and Chief Executive said, "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."