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Gen-Probe H1N1 flu test

This article was originally published in The Gray Sheet

Executive Summary

FDA grants emergency use authorization for Gen-Probe's Prodesse ProFlu-ST flu test, to be used in high-complexity CLIA labs to diagnose H1N1 influenza, firm announces Oct. 29. The reverse transcription polymerase chain reaction (RT-PCR) test employs an algorithm linked to seasonal influenza A/H1 and A/H3 virus test results. Other H1N1 flu tests granted EUAs in recent months include Quest Diagnostic's Simplexa Influenza A H1N1 (2009) and Focus Diagnostics Influenza H1N1 (2009) tests ("1The Gray Sheet" Oct. 26, 2009)

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