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FDA Grants Emergency Use Authorization to Roche’s Assay for 2009 H1N1 Influenza Virus

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Roche’s 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 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 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.

Emergency Use Authorization (EUA) is a tool for approving public health countermeasures in the event of a national public health emergency. Under the current EUA, Roche can provide the RealTime ready Influenza A/H1N1 Detection Set to CLIA high-complexity labs for the duration of the declaration of emergency.