NEW YORK (GenomeWeb) – Molecular diagnostics firm Great Basin Scientific said today that it has submitted a multiplex test for strains of Staphylococcus to the US Food and Drug Administration for 510(k) clearance.
Great Basin submitted the assay after completion of a clinical trial, and the test is the company's first multiplex panel.
The molecular assay detects and identifies S. aureus, S. lugdunensis, and S. epidermis, as well as the mecA gene, which can confer resistance to methicillin. The panel can also signal presence of the remaining Staphylococcus species generally.
"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," Ryan Ashton, co-founder and CEO of Great Basin, said in a statement.
The Great Basin Staph ID/R Blood Culture Panel runs on the same automated system as the firm's commercially available Clostridium difficile and Group B Streptocococcus tests. The firm noted that it plans to offer the panel at a significantly lower cost than other blood panels currently on the market, "making fast, easy diagnosis of staph-caused blood sepsis" affordable for the small to medium hospitals that comprise the company's target market.