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

PENZBERG, Germany, Nov 16, 2009 (BUSINESS WIRE) -- 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 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(R) 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.

For more information on 2009 H1N1 influenza virus please visit www.who.int/csr/disease/swineflu/en/index.html.

About Roche Headquartered in Basel, Switzerland, Roche is a leader in research-focused healthcare with combined strengths in pharmaceuticals and diagnostics. Roche is the world's largest biotech company with truly differentiated medicines in oncology, virology, inflammation, metabolism and CNS. Roche is also the world leader in in-vitro diagnostics, tissue-based cancer diagnostics and a pioneer in diabetes management. Roche's personalised healthcare strategy aims at providing medicines and diagnostic tools that enable tangible improvements in the health, quality of life and survival of patients.

In 2008, Roche had over 80,000 employees worldwide and invested almost 9 billion Swiss francs in R&D. The Group posted sales of 45.6 billion Swiss francs.

Genentech, United States, is a wholly owned member of the Roche Group. Roche has a majority stake in Chugai Pharmaceutical, Japan. For more information: www.roche.com.

LIGHTCYCLER, MAGNA PURE and REALTIME READY are trademarks of Roche.

Other brands or product names are trademarks of their respective holders SOURCE: Roche CONTACT: Roche Diagnostics Dr. Burkhard Ziebolz Phone: [phone] Email: [e-mail] Copyright Business Wire 2009 -0- KEYWORD: Germany

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