Roche
FDA Grants Emergency Use Authorization to Roche´s Assay for 2009 H1N1 Influenza Virus
Published in Medical Letter on the CDC and FDA, December 6th, 2009
Roche`s (SWX:RO) (SWX:ROG) (Pink Sheets: RHHBY) RealTime ready Influenza A/H1N1 Detection Set for the 2009 H1N1 influenza virus has received emergency use authorization (EUA) from the U.S. Food and Drug Administration (FDA). The Roche kit detects RNA from the 2009 H1N1 influenza A virus and allows rapid and accurate identification of patients infected with this virus. It is important to differentiate patients infected with 2009 H1N1 virus from others with similar symptoms so that appropriate patient management can be commenced as early as possible. The efficacy of the Roche assay was demonstrated by clinical evaluation at worldwide study sites.
The RealTime ready...
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