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FDA Clears Nanosphere's Staphylococcus Test

NEW YORK (GenomeWeb News) – Nanosphere today said that the US Food and Drug Administration has given 510(k) clearance for the firm's Verigene Staphylococcus Blood Culture Nucleic Acid Test, or BC-S.

The test was submitted to the agency as the first phase of a multi-step strategy by the Northbrook, Ill.-based company to obtain clearance for a larger test panel, the Verigene BC-GP, which will have up to 16 bacterial/resistance marker targets on a single test cartridge. A submission to FDA for BC-GP is under review, and last week Nanosphere obtained the CE-IVD Mark to market the panel in Europe.

The BC-S test is for detecting Staphylococcus aureus, Staphylococcus epidermis, and the mecA gene, which confers resistance to the antibiotic methycillin/oxacillin. The test provides species and resistance detection from two types of gram-positive blood culture bottles in about 2.5 hours, compared to three days with conventional culture methods, Nanosphere said.

In addition, studies have shown that rapid molecular identification of bacteria as well as resistance can save hospitals up to $21,000 per patient, the company said.