Gen-Probe's Panther Molecular Testing Platform Cleared
Gen-Probe received FDA clearance to market its Panther system, a fully automated and integrated molecular testing platform designed to handle a variety of testing needs. The Panther system can be used with the company's Aptima Combo 2 assay to test for common sexually transmitted infections such as Chlamydia trachomatis and Neisseria gonorrhoeae.
DA Green Lights Five Additional Pathogens for Idaho Technology's Respiratory Panel
FDA cleared five additional pathogens for Idaho Technology’s FilmArray Respiratory Panel. The five additional pathogens cleared include: Bordetella pertussis, Chlamydophila pneumoniae, Mycoplasma pneumoniae, Coronavirus 229E, and Coronavirus OC43. The panel can distinguish between certain bacterial and viral respiratory infections. A year ago, the agency cleared the FilmArray instrument and the FilmArray panel, a multiplex polymerase chain reaction assay, a year ago for 15 respiratory pathogens.
FDA Clears Cepheid Molecular System
Cepheid announced that FDA has cleared the company's GeneXpert Infinity-80 System, a high-throughput automated molecular system that the agency initially cleared in conjunction with the Xpert Flu test. The instrument is available in configurations of 16, 24, 32, 40, 48, 56, 64, 72, and 80 modules, and is designed to adapt to a variety of workflow requirements, including on-demand, batch, or STAT testing. The instrument is capable of generating more than 2,000 automated results per day.