Great Basin Submits Staph ID/R Blood Culture Panel to FDA for Clearance
Salt Lake City -based Great Basin Scientific said Monday it has submitted the Staph ID/R Blood Culture Panel to the FDA for 510(k) clearance.
The submission of the panel, Great Basin’s first multiplex panel to detect blood sepsis caused by MRSA and other staph species, follows a clinical trial that met Great Basin’s objectives.
The panel is expected to allow for a faster diagnosis, compared with traditional blood culture methods, leading to more timely, appropriate therapy, lower treatment costs and shorter hospital stays, Great Basin says.
If approved, hospital and lab technicians will be able to run the new multiplex panel on the same analyzer used to perform Great Basin’s low-plex tests for Clostridium difficile and Group B Streptococcus. — Michael Cipriano