Roche to provide the RealTime ready Influenza A/H1N1 Detection Set to CLIA high-complexity labs under EUA

Dec 3 2009

The Roche assay for the 2009 H1N1 influenza virus detects RNA from the 2009 H1N1 Influenza A virus and provides a rapid means of identification of patients infected with this virus. In order to ensure continued specificity and sensitivity of the Roche's Influenza A/H1N1 assay, Roche performs sequence comparisons with all available 2009 H1N1 Influenza Virus sequences on a regular basis. The detection set primers and probes were evaluated in mid-November, and no significant or relevant changes were identified in the published 2009 H1N1 Influenza sequences that could affect the performance of the Roche assay.

“The appearance of virus mutations is one important aspect of the current pandemic that has to be monitored. Therefore, we always try to keep our test current with H1N1 research,” said Manfred Baier, Head of Roche Applied Science. Roche is cooperating with several research institutes around the world in tracking the virus development.

The RealTime ready Influenza A/H1N1 Detection Set test has been available on the market since May 2009, shortly after the first case was registered. In mid-November, the test received Emergency Use Authorization (EUA) from the U.S. Food and Drug Administration (FDA). 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.

Since its first appearance in April 2009, the pandemic (H1N1) 2009 influenza virus has spread all over the world and is reported to have infected at least 630,000 people. About 7800 people have died as a consequence of the infection. Many laboratories around the world are using the Roche Influenza A/H1N1 assay to test for the pandemic 2009 H1N1 Influenza virus.