NEW YORK (GenomeWeb News) – A number of molecular diagnostic tests that were cleared by the US Food and Drug Administration for emergency use during the height of the 2009 H1N1 influenza outbreak last year have had those authorizations terminated as of last week, according to government officials.
The US Department of Health and Human Services, using an assessment from the US Centers for Disease Control and Prevention, decided last week that the number of new 2009 H1N1 or swine flu cases had this year fallen to normal flu infection rates and that there is no longer a need for a state of emergency.
FDA is aware that a "significant number" of labs have bought and are still using tests that were authorized for emergency use and that a number of these tests will be used after the EUA ended last week, Erica Jefferson of FDA's Office of Public Affairs told GenomeWeb Daily News in an e-mail.
Those test makers who had emergency-use approved tests are encouraged to work with FDA to submit additional information in order to obtain clearance for their devices, Jefferson said.
According to Jefferson, two tests for H1N1 have received FDA's 510(k) clearance for commercial sales including a test developed by Focus Diagnostics and one developed by the CDC.
The group of tests that were covered only by the FDA emergency use authorization includes a Cepheid Xpert Flu Panel; a kit made by Diagnostic Hybrids; an Epoch BioSciences RT-PCR test; a Diatherix Laboratories test; DxNA's GeneStat 2009 A/H1N1 Influenza test; two tests from Focus Diagnostics; an IntelligentMDx real-time RT-PCR test; an H1N1 assay from IQuum; an RT-PCR assay from Longhorn Vaccines and Diagnostics; a Gen-Probe influenza A subtyping assay; an RT-PCR Kit from Qiagen; a Roche Applied Science Influenza/H1N1 Detection Set; TessArae's Influenza & Microarray Detection Panel; a Viacor Laboratories RT-PCR test, and an RT-PCR detection panel developed by the Centers for Disease Control and Prevention.