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Roche Receives Emergency Use Authorization For RealTime Ready Influenza A/H1N1 Detection Set For The 2009 H1N1 Influenza

Roche Diagnostics Limited (Roche) has received emergency use authorization (EUA) from the US Food and Drug Administration (FDA) for RealTime ready Influenza A/H1N1 Detection Set for the 2009 H1N1 influenza virus. The kit detects RNA from the 2009 H1N1 influenza A virus and allows rapid and accurate identification of patients infected with this virus. The worldwide study sites demonstrated the efficacy of the Roche assay.

The RealTime ready Influenza A/H1N1 Detection Set is used in conjunction with the RealTime ready RNA Virus Master kit also provided by Roche. The assay is carried out on the Roche MagNA Pure LC platform for nucleic acid isolation and the LightCycler 2.0 system for real-time PCR. These instruments are available in labs worldwide. By providing detection reagents along with the master mix and necessary equipment, Roche is able to support all phases of the testing process for 2009 H1N1 virus.

“During the last months, our test proved to be reliable in many labs around the world. We are glad that, in granting the EUA, FDA now makes the test available also in the US,” said Manfred Baier, Head of Roche Applied Science.