Originally Published IVD Technology
May 2004
INDUSTRY NEWS
NotablesThe U.S. Department of Agriculture has licensed four rapid tests for bovine spongiform encephalopathy (BSE) to be used in the department’s revamped BSE-screening program. Tests manufactured by Bio-Rad Laboratories (Hercules, CA), Idexx Laboratories (Westbrook, ME), Enfer Scientific (Clonmel, Co Tipperary, Ireland), and Prionics (Schlieren, Switzerland) will be used to test 400,000 animals over the next 12–18 months. The tests will be used by the National Veterinary Science Laboratories (NVSL; Ames, IA) and by various NVSL network laboratories throughout the United States.
The Office of In Vitro Diagnostic Device Evaluation and Safety (OIVD; Rockville, MD) has declared that Ventana Medical Systems’ (Tucson, AZ) human papillomavirus (HPV) test is not an analyte specific reagent. OIVD made this judgment based upon the fact that the inserts for Ventana’s Inform HPV test highlight that HPV tests are used to identify changes associated with cervical cancer. The office recommended that Ventana submit a premarket approval application for the system, its probes, and its reagents.
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