Nanosphere, Inc.'s Bloodstream Infection Test Designated Moderate Complexity by FDA
11/2/2012 7:27:57 AM
NORTHBROOK, Ill., Nov. 1, 2012 (GLOBE NEWSWIRE) -- Nanosphere, Inc. (Nasdaq:NSPH), a leader in the development and commercialization of advanced molecular diagnostics systems, announced today that it received notice from the U.S. Food and Drug Administration (FDA) that its Gram-Positive Blood Culture Nucleic Acid Test (BC-GP) on the Verigene® System has been categorized as Clinical Laboratory Improvement Amendments (CLIA) moderate complexity. This categorization of the BC-GP test underscores the ease of use of the Verigene System and supports the decentralization of molecular testing.
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