FDA Approves Great Basin Scientific Test for Quick Staph Identification

By Ron Shinkman, Editor, Laboratory Industry Report

Salt Lake City-based Great Basin Scientific has said it has received clearance from the U.S. Food and Drug Administration for a test that provides quick results on the precursors of sepsis in the bloodstream.

Known as the Staph ID/R blood culture panel, it is an automated, DNA-based assay that can identify Staphylococcus aureus and related strains directly from positive blood cultures in a couple of hours.

Typical blood culturing can take 24 hours or more to identify such strains. If the patient is suffering from sepsis related to the infection, organ failure can occur relatively rapidly without an appropriate course of treatment.

In addition to identifying the bacteria, the test can also confirm the presence of the mecA gene, which can indicate resistance to the widely used antibiotic methicillin and the presence of the superbug known as MRSA.

“Receiving FDA clearance for our staph blood culture panel marks a major milestone in our growth as a Company,” said Great Basin Scientific Chief Executive Officer Ryan Ashton in a statement. “This menu expansion to four products, along with the five tests we plan to bring to clinical trial in 2016, will add further value for our customers who rely on our analyzer system to perform a greater variety of tests. The customer feedback we’ve received is that we are truly meeting the needs of the small and mid-sized hospital labs with our superior menu versatility, cost efficiency and customer service.”