FDA approves Panther testing system (Gen-Probe) for Sexually Transmitted Infections

The FDA has cleared the Panther system from Gen-Probe. The Panther is a fully automated and integrated molecular testing platform designed to test for the common Sexually Transmitted Diseases Chlamydia trachomatis and Neisseria gonorrhoeae with the APTIMA Combo 2 assay. The Panther system uses fully integrated "sample-in, results-out" automation and a single operator can process 275 samples in eight hours. Gen-Probe will begin shipments of Panther to US customers during the second quarter of 2012. Additional APTIMA women's health assays such as APTIMA Trichomonas vaginalis and APTIMA HPV are expected to be added to the Panther menu as they progress through the regulatory process, and several other assays are currently in development.