Nanosphere (NSPH) Gets FDA 501(k) Clearance for Verigene Staphylococcus BC-S
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Nanosphere, Inc. (Nasdaq: NSPH), has received 510(k) clearance from the FDA for the Verigene Staphylococcus Blood Culture Nucleic Acid Test (BC-S). The BC-S test expands Nanosphere's infectious disease test capabilities to include the rapid detection of bacteria that cause deadly bloodstream infections.
The Verigene BC-S test was submitted to the FDA as the first phase of a stepwise process to obtain clearance for a larger test panel which will be marketed as the Verigene BC-GP test. The test will be comprised of up to 16 bacterial/resistance marker targets, all on a single test cartridge. A second 510(k), needed to obtain clearance for the full BC-GP test panel, is currently under FDA review.* Last week, Nanosphere obtained CE-IVD Mark for regulatory approval of the full BC-GP test as an in vitro diagnostic in Europe.
The Verigene BC-S test was submitted to the FDA as the first phase of a stepwise process to obtain clearance for a larger test panel which will be marketed as the Verigene BC-GP test. The test will be comprised of up to 16 bacterial/resistance marker targets, all on a single test cartridge. A second 510(k), needed to obtain clearance for the full BC-GP test panel, is currently under FDA review.* Last week, Nanosphere obtained CE-IVD Mark for regulatory approval of the full BC-GP test as an in vitro diagnostic in Europe.
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