Great Basin Scientific, Inc., a molecular diagnostics company, has submitted its Staph ID/R Blood Culture Panel to the US Food & Drug Administration (FDA) for 510(k) clearance.
The submission of the Staph ID/R panel, the company’s first multiplex panel, comes after the successful completion of a clinical trial that met all of Great Basin’s clinical objectives. Great Basin offers the first and only molecular diagnostic platform capable of low-plex tests, as well as multiplex and direct-from-specimen panels.
The Great Basin Staph ID/R Blood Culture Panel is a sample-to-result, automated, molecular multiplex panel that detects Staph aureus and two other staph species along with the mecA gene, a major drug resistance marker that confers resistance to methicillin and creates the superbug MRSA. In addition to Staph aureus, the panel also detects Staphylococcus lugdunensis and Staphylococcus epidermidis. The remaining staph species are detected as a group and identified as “Staphylococcus present.” When compared to traditional blood culture methods, results of this panel are expected to allow for a faster diagnosis and therefore a more timely appropriate therapy, which is associated with improved patient outcomes, lower treatment costs, and shorter length of hospital stay for affected patents.
“The successful trial completion and submission to the FDA of our Staph ID/R panel marks a significant milestone for Great Basin, and a critical advancement for our customers and hundreds of thousands of patients in the US who are affected by staph bloodstream infections – including the deadly superbug MRSA – every year,” said Ryan Ashton, co-founder and chief executive officer.
“We are excited to submit our first multiplex panel to the FDA, and look forward to the value this test will add to the Great Basin platform, further setting us apart from other solutions in the molecular diagnostics space with superior scalability and cost efficiency.”
Ryan continued, “I am proud of the determination of the Great Basin team, which continues to execute at the highest level, delivering on the promise to provide current and future customers with a robust menu of easy-to-use and cost effective tests and panels. This panel will be higher value than our low-plex tests and increases our potential revenue per customer by offering higher revenue per test than either our C. diff test, or our GBS test.”
Once approved and commercially available, hospital and lab technicians can run the new multiplex panel on the same analyser used to perform Great Basin’s commercially available low-plex tests for Clostridium difficile (C. diff) and Group B Streptococcus (GBS). Great Basin expects to offer the panel at a significantly lower cost than other blood panels on the market today, making fast, easy diagnosis of staph-caused blood sepsis affordable for the small to medium hospitals the company targets. The company’s unique scale to run a broad assay menu further enhances the economics for its customers, while also allowing Great Basin to grow their business with new and existing customers.