FDA Authorizes Emergency Use of H1N1 Influenza Virus Test

The Food and Drug Administration today announced it has issued an Emergency Use Authorization (EUA) for a another diagnostic test for the 2009 H1N1 influenza virus, whose spread has caused the virus to be characterized as a pandemic by the World Health Organization.

The EUA for the Focus Diagnostics Influenza H1N1 (2009) Real-Time Reverse Transcription Polymerase Chain Reaction (RT-PCR) diagnostic test is the third diagnostic test authorized under an EUA by the FDA since the public health emergency involving the 2009 H1N1 influenza virus was declared on April 26, 2009.

EUA allows Focus Diagnostics to distribute the test to laboratories certified under the Clinical Laboratory Improvement Amendments (CLIA) to perform high complexity tests. This test is not typically utilized in a doctor's office--it is a complex laboratory test performed in an environment that has the necessary equipment. These tests are intended for use in the detection of the 2009 H1N1 influenza virus in patients with symptoms of respiratory infection.

"This authorization will contribute to the nation's capacity for accurate testing for the 2009 H1N1 influenza virus," said Daniel G. Schultz, M.D., director of FDA's Center for Devices and Radiological Health.

The Focus Diagnostics test amplifies the viral genetic material obtained from swabs of the nose or throat, or from nasal discharges. A positive result indicates that the patient is infected with the 2009 H1N1 influenza virus. However, the test does not indicate the stage of infection. A negative result does not preclude influenza virus infection.

The EUA authority allows FDA, based on the evaluation of available data and other things, to authorize the use of unapproved medical products or unapproved uses of approved medical products following a determination and declaration of emergency. The Focus Diagnostics test is an unapproved device whose use is authorized by EUA. The authorization ends when the declaration of emergency is terminated or when the FDA revokes the authorization.

Emergency Use Authorization is part of Project BioShield, which became law in July 2004. Focus Diagnostics is based in Cypress, Calif. For more information, go to www.fda.gov/RegulatoryInformation/Guidances/ucm125127.htm.

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