NEW YORK (GenomeWeb) – Great Basin Scientific today announced it has received 510(k) clearance from the US Food and Drug Administration for its multiplex Staph ID/R Blood Culture Panel.
The test is an automated assay for simultaneous identification of Staphylococcus aureus and other Staphylococcus species, as well as the mecA drug-resistance gene. The test also supports antimicrobial stewardship by identifying coagulase-negative staphylococci, part of the normal flora of human skin that can lead to false positive blood culture.
The sample-to-answer assay runs directly from positive blood cultures in about two hours on the Great Basin Analyzer, which also performs the company’s commercially available tests for Clostridium difficile Group B Streptococcus, and Shiga toxin-producing E. coli.
The assay workflow requires less than one minute of hands-on time and provides electronic results reporting, the firm noted 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," Ryan Ashton, CEO and co-founder of Great Basin Scientific said.
"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."
The FDA cleared Great Basin's Shiga toxin direct test last week. The company also recently reported a net loss of $18.9 million in the fourth quarter of 2015, compared to a net income of $1.5 million in the same quarter last year, though its Q4 revenues improved 37 percent year over year. Great Basin stockholders last week approved a reverse stock split and the firm announced it will effect a 1-for-35 reverse split after the close of the market on March 30.