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FDA Grants First Authorization of a Commercial 2009 H1N1 Flu Test for use During Pandemic Flu Emergency to Quest Diagnostics' Focus Diagnostics Business
Date:7/24/2009

ta, reveal that not only has this pandemic virus not faded away, it is behaving differently than the seasonal flu, which is typically absent during the summer months in the Northern Hemisphere," Dr. Lieberman continued. "When you also factor in the rapid global spread of the virus, particularly the increasing number of cases in certain countries in the Southern Hemisphere, it appears increasingly likely that this novel H1N1 virus could be a major influenza strain circulating in the U.S. this flu season."

Quest Diagnostics is currently in the process of validating the test at a number of its CLIA high complexity laboratories around the U.S. capable of performing the test in compliance with the emergency use authorization. The Quest Diagnostics Focus laboratory in Cypress, CA, currently is the only laboratory performing this test.

For more information about Quest Diagnostics and influenza testing options, please visit www.QuestDiagnostics.com/2009H1N1 or www.FocusDx.com.

About the FDA's Emergency Use Authorization

The U.S. Secretary of Health and Human Services has declared a public health emergency because of the outbreak of the pandemic flu virus. The FDA, in response to requests from the CDC, has issued emergency use authorizations to make important diagnostic and therapeutic tools available to public health and medical personnel in order to identify and respond to the 2009 H1N1 influenza virus under certain circumstances.

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 or uncleared medical products or unapproved or uncleared uses
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SOURCE Quest Diagnostics Incorporated
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