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FDA Issues Another Emergency Use Authorization for Commercial H1N1 Flu Test to Quest Diagnostics' Focus Diagnostics
Date:10/16/2009

The 3M Integrated Cycler is an instrument offering real-time polymerase chain reaction (PCR) technology that provides results in 30-75 minutes. The compact instrument utilizes advanced data management software to help laboratories process, store and transfer data quickly and effectively. In addition, the instrument has a small laboratory footprint at approximately 12 inches high and 12 inches deep, and can process up to 96 samples per run.

"Our reference laboratories typically report results within 24 hours of receipt of specimen," said John G. Hurrell, PhD, vice president and general manager, Focus Diagnostics. "With the Simplexa test on the 3M Integrated Cycler, a typical CLIA high-complexity laboratory can generate results within hours, considerably reducing time spent to send a specimen to an outside lab. Faster turnaround time can aid in clinical management of the patient and allow hospitals to segregate infected patients from other high-risk individuals."

Quest Diagnostics performs H1N1 flu testing using the Focus Diagnostics test authorized for emergency use by FDA in July at its Focus Diagnostics laboratory in Cypress, CA, as well as at its Nichols Institute laboratories in San Juan Capistrano, CA, and Chantilly, VA, and its Specialty Laboratory in Valencia, CA.

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 not cleared or approved any tests for the identification of the 2009 H1N1 influenza virus. The emergency use authorization authority allows the FDA, based on the evaluation of available data, to authorize the use of unapproved and uncleared medical products or unapproved or uncleared uses of appr
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SOURCE Quest Diagnostics Incorporated
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