Great Basin Receives FDA 510(k) Clearance
News Mar 29, 2016
Great Basin Scientific, Inc. has received U.S. Food & Drug Administration (FDA) 510(k) clearance for its Staph ID/R Blood Culture Panel, following submission in August 2015. The Company received notification of clearance from the FDA on March 25, 2016. This is Great Basin’s first multiplex panel to receive FDA clearance, adding to the value and versatility of the company’s analyzer, which is capable of performing low-plex, multiplex and direct-from-specimen assays.
Great Basin’s Staph ID/R Blood Culture Panel is a sample-to-result, automated, DNA multiplex assay for simultaneous identification of Staphylococcus aureus and Staphylococcus species directly from positive blood cultures in about 2 hours. 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 MRSA.
The assay workflow maintains Great Basin’s dedication to ease of use with less than one minute of hands-on time and no results interpretation due to the electronic results reporting. The multiplex panel is run on the Great Basin Analyzer, which also performs the company’s commercially available low-plex tests for Clostridium difficile (C. diff) and Group B Streptococcus (GBS), as well as the company’s stand-alone molecular test for Shiga toxin producing E. coli (STEC) detection.
Patients with a positive blood culture are generally treated with broad-spectrum antibiotics. However, according to the Centers for Disease Control, 20 to 50 percent 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 Great Basin Staph ID/R Blood Culture Panel clearly identifies CoNS, giving care providers the data they need to quickly and more effectively manage patient treatment and reduce the unnecessary use of broad-spectrum antibiotics. A more complete diagnostic test drives disease-appropriate treatment that supports antimicrobial stewardship, saving this last line of defense in the battle against antibiotic resistance and also helping lower treatment cost to patients, the hospital, and the healthcare system.
“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,” said Ryan Ashton, cofounder and Chief Executive Officer 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 customer feedback we’ve received is that we are truly meeting the needs of the small and midsized hospital labs with our superior menu versatility, cost efficiency and customer service.” Great Basin expects to offer the panel at a significantly lower cost than other molecular blood panels on the market today, making fast, easy diagnosis of staph-caused blood sepsis affordable for the small to medium hospitals the Company serves.