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Gen-Probe Files for FDA Approval of Panther System

By a GenomeWeb staff reporter

NEW YORK (GenomeWeb News) – Gen-Probe today announced it has filed for regulatory approval in the US for its Panther molecular diagnostics system.

The platform, which received CE marking in late 2010, is a fully automated and integrated molecular testing system which complements Gen-Probe's Tigris system. The company filed for 510(k) clearance from the US Food and Drug Administration to run the Aptima Combo 2.0 assay, a dual test for chlamydia and gonorrhea, on Panther. Gen-Probe added that it is developing other qualitative and quantitative assays for the system.

"Filing our US regulatory application for the Panther system on time is another important milestone in our efforts to create differentiated value for our laboratory customers," Carl Hull, president and CEO of Gen-Probe, said in a statement. "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."