On July 24, the U.S. Food and Drug Administration ("FDA") announced it had granted emergency use authorization ("EUA") to the Focus Diagnostics test, the first granted to a commercial test for detecting the 2009 H1N1 influenza virus. On August 17, FDA informed Focus Diagnostics that it had issued an amended EUA for the company's test to reflect labeling clarifications regarding the contents of the test kit. According to the EUA, the test may be performed in laboratories certified under the U.S. Clinical Laboratory Improvement Amendments ("CLIA") to perform high-complexity tests and operating certain equipment.

In April 2009, the FDA granted two EUAs in connection with the CDC's RT-PCR diagnostic panel used by public health labs in the U.S. to detect the 2009 H1N1 influenza virus infection. In its EUA application to the FDA, Focus Diagnostics presented data involving more than 100 clinical specimens indicating that the Focus Diagnostics test agreed 100% with the CDC's RT-PCR test in identifying specimens as positive or negative for the pandemic virus.

For more information about Quest Diagnostics and influenza testing options, please visit www.FocusDx or www.QuestDiagnostics/2009H1N1.

Source: QuestDiagnostics