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GEN News Highlights : Dec 1, 2010

Gen-Probe’s Panther MDx System CE Marked and Launched in Europe

Initial tests for the system include Aptima assays for gonorrhea and chlamydia.

Gen-Probe has been granted a CE mark for its automated molecular diagnostics system, Panther™. Tests initially available for use with Panther include the sexually transmitted infection assays, Aptima Combo 2®, Aptima CT (chlamydia), and Aptima GC (gonorrhea) assays. A number of other qualitative and quantitative assays are also in development, Gen-Probe notes. Panther will be launched immediately in Europe but has yet to be sanctioned by FDA for commercialization in the U.S., the firm adds.

Panther has been designed as a “sample-in-result-out” instrument that fully automates all aspects of nucleic acid testing for small- to medium-sized laboratories. Developed to build on the success of Gen-Probe’s existing Tigris® system for large diagnostics laboratories, the Panther platform reportedly allows a single operator to process 275 samples in eight hours, with just one hour of hands-on time. For higher throughput the system is capable of processing 500 samples in 12 hours, Gen-Probe states.

Panther has been over three years in development, and European launch has been achieved a month ahead of schedule, remarks Carl Hull, Gen-Probe president and CEO. “We believe the Panther system will revolutionize molecular diagnostics by offering customers high levels of productivity and instrument flexibility that were once reserved for high-throughput clinical chemistry and immunoassay systems.”