Great Basin Staph ID-R copy

Benchtop analyzer from Great Basin Scientific Inc.

Great Basin Scientific Inc, Salt Lake City, has received FDA premarket notification (510(k)) clearance for its Staph ID/R blood culture panel, the company’s first multiplex panel to receive FDA clearance.

The panel is a sample-to-result, automated, multiplex DNA assay for simultaneous identification of Staphylococcus aureus and other Staphylococcus species directly from positive blood cultures in about 2 hours. Requiring less than 1 minute of hands-on time, the panel also detects the mecA gene, a major drug-resistance marker that confers resistance to methicillin and other beta-lactams and creates the superbug methicillin-resistant Staphylococcus aureus.

Patients with a positive blood culture are generally treated with broad-spectrum antibiotics. However, according to the Centers for Disease Control and Prevention, 20–50% of all positive blood cultures are likely false positives due to contamination caused by coagulase-negative staphylococci (CoNS), many of which—like S. epidermidis—are part of the normal flora of human skin and are not dangerous. The company’s ID/R blood culture panel clearly identifies CoNS, providing healthcare professionals with data to manage patient treatment and reduce the unnecessary use of broad-spectrum antibiotics.

“Receiving FDA clearance for our Staph ID/R blood culture panel—our second FDA clearance this month—marks a major milestone in our growth as a company,” says Ryan Ashton, cofounder and CEO of Great Basin Scientific. “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 multiplex panel is run on the company’s analyzer, which also performs the company’s commercially available lowplex tests for Clostridium difficile and Group B Streptococcus, as well as the company’s standalone molecular test for Shiga toxin-producing E. coli detection.

For more information, visit Great Basin Scientific.