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Quest Diagnostics' H1N1 Flu PCR Test Gets FDA Clearance


This article was originally published on May 24.

Quest Diagnostics said today that it has received 510(k) clearance from the US Food and Drug Administration for its Simplexa Influenza A H1N1 (2009) test on the 3M Integrated Cycler.

Quest said that Simplexa, manufactured by its Focus Diagnostics business, is the first test to be cleared by the FDA to aid in detecting and differentiating influenza A and 2008 H1N1 influenza viral RNA. All other molecular tests for H1N1 flu have been approved under the FDA's emergency use authorization program, which is slated to end in June.

Simplexa runs on the 3M Integrated Cycler under an exclusive global distribution agreement between Focus Diagnostics and 3M. As reported in October by PCR Insider sister newsletter GenomeWeb Daily News, the Integrated Cycler is a benchtop, microfluidics-based thermal cycler that can process up to 96 samples in 30 to 75 minutes (GWDN, 10/26/2009).

The test uses real-time reverse-transcription PCR to qualitatively detect RNA from 2009 H1N1 flu virus in a patient's nasal or nasopharyngeal specimens, and is able to report if a specimen is positive or negative for the presence of 2009 H1N1 or influenza A virus.

"Thankfully, H1N1 is not currently a widespread public health problem, but reliable detection continues to be important to help manage high-risk patients, such as expectant mothers who have flu-like symptoms," Jay Lieberman, medical director for infectious diseases at Quest and Focus, said in a statement.

Lieberman added that reliable tests for flu are needed given the unpredictability of the virus.

Focus, which Quest acquired in 2006, was the first company to receive an EUA from the FDA for a commercial H1N1 2009 test and the first to launch a commercial test kit to qualitatively detect H1N1 RNA using RT-PCR.