SUNNYVALE, Calif. — Cepheid announced Jan. 4 that it has been granted emergency use authorization from the U.S. Food and Drug Administration for its Xpert Flu A Panel test.
The test, which runs on Cepheid's GeneXpert System, identifies the 2009 H1N1 influenza virus in less than one hour.
The FDA has authorized Cepheid's Xpert Flu A Panel to be used in laboratories certified to perform "moderate complexity" (not waived) testing, enabling the test to be performed in hospital near-patient settings.
"Although PCR testing is now recognized as the new gold standard for detection of influenza virus infection, test availability for 2009 H1N1 has so far been limited to high-complexity laboratories and results are not typically available around the clock,” said John Bishop, Cepheid's CEO. “Xpert Flu A Panel combines the convenience and ease-of-use of rapid testing with the performance of PCR, in a test format that maximizes medical value by providing results when they are most needed."
The FDA has issued emergency use authorizations to make diagnostic and therapeutic tools available to public health and medical personnel for use in the diagnosis of 2009 H1N1 influenza virus under certain circumstances.
"An easy-to-use, rapid PCR-based 2009 H1N1 test can assist clinicians in making real-time medical decisions that help hospitals significantly improve their patient management," said Dr. Preveen Ramamoorthy, director of molecular diagnostics at National Jewish Health in Denver.
Cepheid is an on-demand molecular diagnostics company that develops, manufactures and markets fully integrated systems and tests for genetic analysis in clinical, industrial and biothreat markets.