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Roche Gets FDA EUA for H1N1 Test Kit

NEW YORK (GenomeWeb News) – Roche has become the latest firm to receive an Emergency Use Authorization from the US Food and Drug Administration for a 2009 H1N1 influenza test kit.

The firm said today that the FDA has granted the EUA for its RealTime ready Influenza A/H1N1 Detection Set. The kit rapidly detects RNA from the 2009 H1N1 influenza A virus and is used in conjunction with Roche's RealTime ready RNA Virus Master kit.

Roche said that the assay is run on its MagNA Pure LC platform for nucleic acid isolation and its LightCycler 2.0 system for real-time PCR applications.

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

Roche becomes the latest supplier to get an FDA EUA for a 2009 H1N1 influenza test. The first assay to receive the EUA was developed by the US Centers for Disease Control and Prevention and was cleared in April. Since then, the FDA has also granted EUAs to Focus Diagnostics, which is owned by clinical lab giant Quest Diagnostics, Gen-Probe's Prodesse business, and clinical lab Diatherix Laboratories.

Roche said that under the EUA it can provide the RealTime ready Influenza A/H1N1 Detection Set to CLIA high-complexity labs for the duration of the declaration of emergency.