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2009 H1N1 Flu Test From Quest Diagnostics Now CE Marked For International Distribution Under The Simplexa(TM) Brand Name
Date:11/17/2009

t is accepted as confirmation" of human infection with the 2009 H1N1 pandemic virus.(1)

The Focus Diagnostics Simplexa(TM) Influenza A H1N1 (2009) test is an outgrowth of an exclusive global distribution agreement between Focus Diagnostics and 3M (NYSE: MMM) under which Focus will develop and offer molecular diagnostic test kits, to be sold under the Simplexa brand name, on the 3M Integrated Cycler. The 3M Integrated Cycler supports real-time polymerase chain reaction (PCR) technology and employs advanced data management software to help laboratories process, store and transfer data quickly and effectively. It can process up to 96 samples per run, and provides results in 30 to 85 minutes, depending on the test's parameters. It has a small laboratory footprint, at approximately 31 centimeters (12 inches) high and 31 centimeters long.

The Simplexa Influenza A H1N1 (2009) test, which was launched in October 2009, is the first offering from the Simplexa product line. Focus Diagnostics plans to launch additional Simplexa test kits on the 3M Integrated Cycler for infectious diseases in 2010, pending required regulatory clearances.

Quest Diagnostics' Focus Diagnostics has a track record of being first to market with new laboratory testing services for emerging infectious diseases. The company introduced a 2009 H1N1 flu test approximately two weeks after the U.S. Department of Health and Human Services declared a pandemic emergency in the U.S. in late April. The U.S. Food and Drug Administration (FDA), the regulatory body that oversees diagnostic testing in the U.S., granted emergency use authorizations to Focus Diagnostics for its first test as well as its new Simplexa test.

"Expanded influenza capability could be critically important as the pandemic virus continues its spread globally," said John G. Hurrell, PhD, vice
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SOURCE Quest Diagnostics Incorporated
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