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Osmetech requests FDA emergency approval for swine flu test

This article was originally published in Clinica

Executive Summary

In a bid to allow the use of its respiratory pathogen test panel to diagnose swine flu, Osmetech has applied to the US FDA for emergency use authorisation (EUA). EUAs are used during public healthcare emergencies; a state of emergency was declared in the US on April 26. The Pasadena, California-based molecular diagnostics firm expects to launch the panel – designed to identify 18 bacterial and viral infections, including the influenza A H1N1 swine flu virus – in the next quarter, for research use only. It is now developing an extension to differentiate between the human and swine forms of the H1N1 virus. The panel, adapted from Qiagen's QIAplex-based respiratory viral test, runs on Osmetech's eSensor XT-8 system.

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