Cepheid has announced the accelerated development of a Flu A (Influenza Virus) Panel test for use on the GeneXpert System. The test will be designed to provide 45-minute identification of Flu A infection, with specific presumptive identification of seasonal H1, seasonal H3, and H1N1 novel strain types. Following review of the Request for Consideration for Emergency Use Authorization (EUA) by the US Food & Drug Administration (FDA), the test is expected to be authorized for use during the upcoming influenza season, with product shipments beginning in January 2010.
"In reviewing the needs of the healthcare system, it became apparent that the GeneXpert is a key potential solution to the universal need for rapid and accurate flu testing on both a centralized and disseminated basis," said John Bishop, Cepheid's Chief Executive Officer. "In recognition of this universal need, we reprioritized longer term projects within the company in order to deliver this product in a timely manner."
Subsequent to the EUA request for consideration by the FDA, the test will be made available in Europe as a CE IVD product.
"Currently, laboratories do not have a rapid test to discriminate among the multiple influenza strains expected to be present this flu season -- each of which have different antiviral drug susceptibilities," said David Persing, MD, PhD, Cepheid's Executive Vice President, Chief Medical & Technology Officer. "To make this test available as quickly as possible, we plan to accelerate development by leveraging the work completed on a previous influenza project supported through a 2007 contract with the Department of Health and Human Services (HHS) and Centers for Disease Control and Prevention (CDC)."
Following EUA request to the FDA, development of Cepheid's Flu Panel test will continue by adding additional target identification for Flu B. For that product, a separate 510(k) submission is expected in 2010.
The GeneXpert System is a closed, self-contained, fully-integrated and automated platform that represents a paradigm shift in the automation of molecular analysis, producing accurate results in a timely manner with minimal risk of contamination. The GeneXpert System is the only system to combine on-board sample preparation with real-time PCR (polymerase chain reaction) amplification and detection functions for fully integrated and automated nucleic acid analysis. The system is designed to purify, concentrate, detect and identify targeted nucleic acid sequences thereby delivering answers directly from unprocessed samples. Modular in design, the GeneXpert System has a variety of configurations to meet the broad range of testing demands of any clinical environment.