Nanosphere gets FDA Verigene SP, Flu Test Approval
Tue, 10/13/2009 - 5:10am
NORTHBROOK, Ill. (AP) — Molecular diagnostics maker Nanosphere Inc. said Tuesday the Food and Drug Administration approved its automated Verigene SP system, and a test for the flu and respiratory syncytial virus. Nanosphere said the FDA granted marketing clearance to both products. On the Verigene SP system, samples are taken from a patient and processed at the same location, with results available in a few hours, the company said. The new testing product can detect influenza A and B strains, as well as RSV. RSV produces mild symptoms similar to a cold, but in young and elderly patients, or people with chronic health problems or heart and lung disease, it can cause pneumonia or death.