Sunnyvale-based Cepheid announced this week that the United States Food and Drug Administration (FDA) has granted the company’s Xpert Flu A Panel test ‘Emergency Use Authorization’ to identify cases of H1N1 flu. According to the company, the test can identify the 2009 H1N1 virus in less than an hour. This emergency use is set to expire April 26, 2010 or earlier.

The FDA authorized Cepheid's test to be used in laboratories certified under the Clinical Laboratory Improvement Amendments to perform “moderate complexity” (not waived) testing, which means the test can be done in hospital near-patient settings.

In a release, John Bishop, Cepheid’s Chief Executive Officer, said his company’s test can help address the need for faster results.

"Accuracy combined with ease-of-use and the broad testing applicability of the [system] offers a helpful unique diagnostic solution in helping to address this healthcare issue," said Bishop.

As H1N1 has been declared a public health emergency by the US Secretary of Health and Human Services, the FDA has issued emergency use authorizations to make diagnostic and therapeutic tools available to public health and medical personnel under certain circumstances. No tests have been cleared or approved by the FDA for identification of the 2009 H1N1 virus.

The test runs on Cepheid's GeneXpert System.