Focus Diagnostics responded quickly to the threat of 2009 H1N1 influenza
Photo Credit:
C. S. Goldsmith and A. Balish, CDC

THE H1N1 STORY

Developing a diagnostic test amidst the global influenza pandemic

In the midst of a global influenza pandemic, our laboratory responded quickly to the threat of 2009 H1N1 influenza. In just 20 days from the first report of “swine flu” in children in California, Focus Diagnostics developed and offered its Influenza A H1N1 (2009) assay.

Focus was granted the first commercial Emergency Use Authorization (EUA) from the FDA for the Focus Reference Laboratory’s Influenza A H1N1 (2009) assay, and another EUA in October 2009 for the Simplexa™ Influenza A H1N1 (2009) assay on the 3M Integrated Cycler.

Focus Diagnostics submitted a 510(k) to the FDA, and as of May 24, 2010, the Simplexa™ Influenza A H1N1 (2009) assay on the 3M Integrated Cycler is cleared for in vitro diagnostics use, and not just approved for emergency use.