FDA grants emergency use authorisation to Roche's H1N1 assay
Swiss drugmaker Roche has received emergency use authorisation (EUA) approval from the US Food and Drug Administration (FDA) for its RealTime ready Influenza A/H1N1 Detection Set for the 2009 H1N1 influenza virus. The Roche kit detects RNA from the virus and allows accurate identification of infected patients. The efficacy of the Roche assay has been demonstrated by clinical evaluation at worldwide study sites, the company says.
Swiss drugmaker Roche has received emergency use authorisation (EUA) approval from the US Food and Drug Administration (FDA) for its RealTime ready Influenza A/H1N1 Detection Set for the 2009 H1N1 influenza virus. The Roche kit detects RNA from the virus and allows accurate identification of infected patients. The efficacy of the Roche assay has been demonstrated by clinical evaluation at worldwide study sites, the company says.
The detection set is used with Roche's RealTime ready RNA Virus Master kit. The assay is carried out on the Roche MagNA Pure LC platform for nucleic acid isolation and the LightCycler 2.0 system for realtime PCR. By providing detection reagents along with the master mix and necessary equipment, Roche says it can support all phases of the testing process for the virus.