Skip to main content
Premium Trial:

Request an Annual Quote

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.

The Scan

Transcriptomic, Epigenetic Study Appears to Explain Anti-Viral Effects of TB Vaccine

Researchers report in Science Advances on an interferon signature and long-term shifts in monocyte cell DNA methylation in Bacille Calmette-Guérin-vaccinated infant samples.

DNA Storage Method Taps Into Gene Editing Technology

With a dual-plasmid system informed by gene editing, researchers re-wrote DNA sequences in E. coli to store Charles Dickens prose over hundreds of generations, as they recount in Science Advances.

Researchers Model Microbiome Dynamics in Effort to Understand Chronic Human Conditions

Investigators demonstrate in PLOS Computational Biology a computational method for following microbiome dynamics in the absence of longitudinally collected samples.

New Study Highlights Role of Genetics in ADHD

Researchers report in Nature Genetics on differences in genetic architecture between ADHD affecting children versus ADHD that persists into adulthood or is diagnosed in adults.