www.fdanews.com/articles/175922-great-basin-gains-fda-clearance-for-multiplex-panel
Great Basin Gains FDA Clearance for Multiplex Panel
March 28, 2016
Great Basin Scientific has garnered FDA clearance for its staph ID/R blood culture panel for low-plex, multiplex and direct-from-specimen assays, the Salt Lake City, Utah diagnostics company announced yesterday.
The company nabbed FDA clearance last Friday and expects to market the panel at a “significantly lower cost” compared with available options, the company says.
The multiplex panel aims to identify staphylococcus aureus and staphylococcus species from positive blood cultures in approximately two hours. Further, it detects the drug–resistant mecA gene. — Anisa Jibrell