FDA Grants First Authorization of a Commercial 2009 H1N1 Flu Test for use During Pandemic Flu Emergency to Quest Diagnostics' Focus Diagnostic...( MADISON N.J. July 24 /- Q...)

MADISON, N.J., July 24 /PRNewswire-FirstCall/ -- Quest Diagnostics Incorporated (NYSE: DGX), the world's leading provider of diagnostic testing, information and services, today announced that the U.S. Food and Drug Administration (FDA) has granted an emergency use authorization to the company's Focus Diagnostics business for its test for detecting the 2009 H1N1 influenza virus (the "pandemic flu virus"), a strain of influenza A virus initially referred to as the swine flu virus.

The Influenza A H1N1 (2009) Real Time RT-PCR test is the first commercial lab test to be granted an emergency use authorization by the FDA for testing for the 2009 H1N1 influenza virus. It is also the first test to qualitatively detect RNA of the pandemic flu virus in a patient's nasal or nasopharyngeal specimens. The test targets two separate regions of the hemagglutinin gene of the 2009 H1N1 influenza virus to differentiate the presence of the pandemic virus from seasonal human influenza A virus. Turnaround time for reporting results is typically within 24 hours of receipt of specimen.

"This emergency use authorization means that the Influenza A H1N1 (2009) Real Time RT-PCR, when combined with clinical and epidemiological assessments, can aid physicians in diagnosing patients infected with the 2009 H1N1 influenza virus versus other influenza A virus strains," said Jon R. Cohen, M.D., senior vice president and chief medical officer, Quest Diagnostics. "This capability could be critically important in aiding clinicians in determining which Influenza A virus is causing an infection should there be a surge in flu cases during the fall and winter flu season. We will continue to work closely with public health officials, who have done an outstanding job managing the pandemic, to mitigate its effect on public health."

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