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FDA Grants Second Authorization for Focus Diagnostics' H1N1 Flu Test

NEW YORK (GenomeWeb News) – Clinical lab firm Quest Diagnostics said Friday that the US Food and Drug Administration has issued a second emergency use authorization for a 2009 H1N1 flu test made by its Focus Diagnostics subsidiary.

Quest said that the new EUA allows Focus to market and offer its Simplexa Influenza A H1N1 (2009) test for use on 3M's Integrated Cycler to CLIA high-complexity laboratories for the duration of the emergency period. 3M's system is a microfluidic molecular diagnostic testing system that is not yet cleared by the FDA.

Focus and 3M previously signed an exclusive distribution deal, under which Focus will develop and offer its first line of molecular diagnostic test kits, to be sold under the Simplexa brand name, on the 3M Integrated Cycler.

"FDA's EUA for our new Simplexa H1N1 test on the 3M Integrated Cycler is a major advance for 2009 H1N1 influenza testing," Jon Cohen, senior VP and chief medical officer of Quest Diagnostics, said in a statement. "Until now, many CLIA-high complexity labs didn't have the technology, space or expertise to perform molecular testing for the 2009 H1N1 flu virus."

In July, the FDA granted an EUA for Focus to sell its 2009 H1N1 flu test to run on diagnostic systems made by Roche and Life Technologies' Applied Biosystems business.