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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

president and general manager, Focus Diagnostics. "Our Simplexa test affords many hospital, health clinic and reference laboratories the ability to quickly produce results, even when faced with high volumes of testing, using a compact, reliable molecular device."

To order the test, please contact Focus Diagnostics at 800-445-0185 (U.S.) or +49-6026-9499540 (Europe). You may also email us at H1N12009@focusdx.com. For more information about Quest Diagnostics and influenza testing options, please visit www.QuestDiagnostics.com/2009H1N1 or www.FocusDx.com/2009H1N1.

About the FDA's Emergency Use Authorization

The FDA has authorized Focus Diagnostics to market and offer its Simplexa(TM) Influenza A H1N1 (2009) test for use on the 3M(TM) Integrated Cycler to CLIA high-complexity laboratories for use during the emergency. The 3M Integrated Cycler is a microfluidic molecular diagnostic testing system and is not FDA cleared or approved. This Simplexa(TM) Influenza A H1N1 (2009) test has not been FDA cleared or approved. This test has been authorized by FDA under an Emergency Use Authorization. This test is only authorized for the duration of the declaration of emergency under section 564(b)(1) of the Act, 21 U.S.C. section 360bbb-3(b)(1). The declaration of emergency will expire on April 26, 2010, unless it is terminated or revoked sooner or renewed.

About Focus Diagnostics

Focus Diagnostics, Inc. is an infectious disease diagnostics company, providing infectious disease reference laboratory services to hospitals and laboratories nationwide, and manufacturing and distributing diagnostic products worldwide. Focus Diagnostics develops innovative tests and products to assist physicians in diagnosin
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SOURCE Quest Diagnostics Incorporated
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