Another diagnostic test for the 2009 H1N1 influenza virus received an Emergency Use Authorization by the Food and Drug Administration.
The Focus Diagnostics Influenza H1N1 (2009) Real-Time Reverse Transcription Polymerase Chain Reaction (RT-PCR) diagnostic test is the third H1N1 diagnostic test to be authorized by the FDA under the Emergency Use Authorization since a public health emergency involving the virus was declared, the agency said in a written statement.
The Emergency Use Authorization allows use of unapproved medical products or unapproved uses of approved medical products following a declaration of emergency.
The Focus Diagnostics test is an unapproved device. The authorization ends once the emergency is terminated or when the FDA revokes the authorization. Focus Diagnostics will be permitted to distribute the test to laboratories certified under the U.S. Clinical Laboratory Improvement Amendments (CLIA) to perform high complexity tests.
"This authorization will contribute to the nation's capacity for accurate testing for the 2009 H1N1 influenza virus," Dr. Daniel G. Schultz, director of the FDA's Center for Devices and Radiological Health, said in a released statement.
Focus Diagnostics is a subsidiary of Quest Diagnostics and is located in Cypress, Calif.