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Focus' Simplexa becomes first FDA-cleared H1N1 diagnostic

This article was originally published in Clinica

Executive Summary

The US FDA has granted the first 510(k) clearance for an H1N1 test – Focus Diagnostics' Simplexa Influenza A H1N1 (2009) product. Previously, tests for the virus were only available through an emergency use authorisation (EUA), which allows the use of unapproved medical products during public health emergencies. The latest clearance means that the Simplexa test will still be available once the emergency expires. The test, which runs on the 3M Integrated Cycler, identifies H1N1 RNA using real-time reverse transcription PCR. It received an EUA in October 2009 (, 19 October 2009). Focus, a wholly-owned subsidiary of Quest Diagnostics, also CE marked it for sale in Europe in November 2009.

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