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FDA Grants Emergency Use Authorization To Quest Diagnostics’ Influenza A H1N1 (2009) Real Time RT-PCR Test

Quest Diagnostics Incorporated announced that the company was granted an emergency use authorization to Influenza A H1N1 (2009) Real Time RT-PCR test for detecting the 2009 H1N1 influenza virus from US Food and Drug Administration (FDA).

The Influenza A H1N1 (2009) Real Time RT-PCR test qualitatively detects 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 so as to differentiate the presence of the pandemic virus from seasonal human influenza A virus. The test’s 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.

Approximately three fourths for patients between the ages of five to 20 years have tested positive for the 2009 H1N1 influenza virus. These samples were tested by Focus Diagnostics. By comparison, positivity rates in adults 21 to 40 years of age have averaged approximately 49 percent over the past two months, adults between 41 to 60 years of age have experienced positivity rates of 36 percent and those 61 to 80 years of age have experienced positivity rates of approximately 14 percent.

Our data are consistent with CDC data suggesting that this pandemic flu virus is disproportionately affecting children and young adults, as compared to older adults, Jay M. Lieberman, M.D., medical director, Focus Diagnostics, said. In fact, almost 60 percent of all positive results identified by our test have been in children 18 or younger.

In addition, our data, consistent with CDC data, 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 US this flu season.