IntelligentMDx (IMDx) has claimed that its IMDx 2009 Influenza A H1N1 Real-Time RT-PCR Assay has been granted Emergency Use Authorization (EUA) from the FDA. The test, which is authorized for use on multiple instrument platforms by CLIA High Complexity Laboratories to detect and differentiate 2009 Influenza A H1N1, uses a single test format and produces results in 90 minutes.
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 emergency use authorizations to make important diagnostic and therapeutic tools available to public health and medical personnel in order to identify and respond to the 2009 H1N1 influenza virus under certain circumstances.
The FDA has not cleared or approved any tests for the identification of the 2009 H1N1 influenza virus. The emergency use authorization authority allows the FDA, based on the evaluation of available data, to authorize the use of unapproved or uncleared medical products following a determination and declaration of emergency, provided certain criteria are met.
The IMDx 2009 Influenza A H1N1 Real-Time RT-PCR Assay is authorized for the duration of the emergency, unless the authorization is revoked sooner. The declaration of emergency will expire on April 26, 2010, unless it is terminated sooner or renewed.
Alice Jacobs, chairman and CEO of IMDx, said: “By receiving authorization for use on multiple instrument platforms, IMDx is able to provide a rapid assay solution that is flexible and adaptable to the wider needs of molecular diagnostics laboratory customers.”