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Focus Diagnostics expands launch of H1N1 test to CLIA labs

This article was originally published in Clinica

Executive Summary

Focus Diagnostics has made its H1N1 pandemic flu test available to other US labs with CLIA certification. The Cypress, California company is also "assessing its options" for marketing the Influenza A H1N1 (2009) Real Time RT-PCR test outside the US. The US FDA granted emergency use authorisation (EUA) for the diagnostic in July, making it the first commercially available H1N1 test. On August 17, the agency informed Focus – a subsidiary of Quest Diagnostics – that it had amended the EUA for the test. It now states that the test may be performed in labs certified under the US CLIA act to perform high-complexity tests and operate certain equipment.

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