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Second Focus Diagnostics' flu test cleared via emergency use authorisation

This article was originally published in Clinica

Executive Summary

The US FDA has granted emergency use authorisation (EUA) for Focus Diagnostics' Simplexa Influenza A H1N1 (2009) test. It runs on the 3M Integrated Cycler, a PCR-based system that is not yet FDA-approved, which provides results in 30-75 minutes. The test can now be used by the estimated 6,500 CLIA high-complexity labs in the US, including certain hospitals and regional labs. It could therefore help health services cope with a surge in testing demands, Focus – a wholly-owned subsidiary of Quest Diagnostics – believes. In July, the FDA granted an EUA for Focus' 2009 H1N1 flu test, making it the first diagnostic to receive such an approval (www.clinica.co.uk, July 27 2009).

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