Emergency approval for IntelligentMDx's H1N1 test
This article was originally published in Clinica
Executive Summary
An H1N1 test from IntelligentMDx (IMDx) has become the latest to be granted emergency use authorisation (EUA) from the US FDA for pandemic flu. The company claims the Influenza A H1N1 real-time RT-PCR assay is the first authorised for use on multiple instruments. This includes Applied Biosystems' 7500 Fast real-time PCR system and 7500 Fast Dx real-time PCR instrument. The test produces results in 90 minutes, Cambridge, Massachusetts-based IMDx says, and is intended for use in labs with high-complexity CLIA certification. The diagnostic will now be available for the duration of the emergency declaration, which is set to expire on April 26 2010.