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FDA clears Focus Diagnostics's flu/RSV test kit

This article was originally published in Clinica

Executive Summary

The US FDA has issued 510(k) clearance for the Simplexa Flu A/B & RSV test on the 3M Integrated Cycler. The Simplexa test, developed by Quest Diagnostics subsidiary Focus Diagnostics (Cypress, California), is designed to detect and discriminate between influenza A, influenza B and respiratory syncytial virus (RSV) infections. It is the first molecular test cleared by the FDA for detecting flu viruses and RSV that does not require confirmation of test results by other methods, such as culture. The test takes about an hour to complete, and delivers results in less than three hours. The new test is the second Simplexa RT-PCR molecular test to run on the 3M integrated Cycler as part of a distribution agreement between Focus and 3M. In May, the Simplexa Influenza A H1N1 (2009) test became the first to receive FDA clearance for the detection of the 2009 H1N1 flu virus (www.clinica.co.uk, 25 May 2010).

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