Nanosphere is set to provide additional data to the Food and Drug Administration (FDA) in relation to the Verigene Clopidogrel Metabolism Nucleic Acid Test (Plavix Metabolism) premarket approval (PMA) application following the issuance of a not approvable letter.
Nanosphere develops and manufactures molecular diagnostics platform – the Verigene System – for multiplexed infectious disease, genetic, and ultra-sensitive protein testing.
The platform offers laboratories a solution for sensitive nucleic acid and protein testing.
The Plavix Metabolism test is CE IVD marked and currently being sold in certain European markets.
The company intends to launch the product in additional European and Asian markets before the end of 2011.