FDA Clears Quest's Simplexa H1N1 Assay; Test Runs on New 3M Integrated Cycler

May 24, 2010

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Quest Diagnostics' Simplexa Influenza A 2009 H1N1 assay has received 510(k) clearance from the FDA, making it the first test of its kind to receive marketing approval outside the agency's time-limited emergency-use authorization program.

The test, which received the CE mark in Europe last fall, is designed to run on the 3M Integrated Cycler, which was co-developed with Quest's Focus Diagnostics business. It is indicated for patients with signs and symptoms of respiratory infection, according to the FDA.

The test uses real-time reverse transcription PCR to qualitatively detect RNA of the virus in a patient’s nasal or nasopharyngeal specimens. Results show whether the individual is positive or negative for the presence of 2009 H1N1 or influenza A virus.

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