First 2009 H1N1 influenza assay for CLIA identifies virus in less than one hour
Cepheid has been granted Emergency Use Authorization (EUA) from the FDA for its ‘Xpert’ Flu A Panel test. The test, which runs on GeneXpert System, identifies the 2009 H1N1 influenza virus in less than one hour, said the company.
The FDA has authorized Cepheid’s Xpert to be used in laboratories certified under the Clinical Laboratory Improvement Amendments (CLIA) to perform ‘moderate complexity’ (not waived) testing, enabling the test to be performed in hospital near-patient settings.
The company will continue development of an expanded influenza panel product to test for Influenza A, with strain identification for H1 seasonal and H3 seasonal influenza A subtypes, the 2009 H1N1 subtype, and Influenza B. For that product, the company is expected to submit a separate 510(k) in 2010.
The company expects Xpert Flu A Panel to become available in Europe as a CE IVD mark product under the European Directive on in-vitro diagnostic medical devices.
The US Secretary of Health and Human Services has declared a public health emergency because of the outbreak of the pandemic flu virus. The FDA has issued EUA 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.
Cepheid claims that its 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 system is designed to purify, concentrate, detect and identify targeted nucleic acid sequences thereby delivering answers directly from unprocessed samples.