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."
Quest Diagnostics' Focus business, which has a track record of being first to market with new laboratory testing services for emerging infectious diseases, developed and, in May 2009, launched the laboratory developed test to help offload an expected backlog of testing from public health laboratories. In the U.S., public health labs employ the CDC's rRT-PCR test, which the FDA authorized for emergency use in April 2009. Public health labs may use the CDC test to determine if certain high-risk patients who test positive for influenza A virus by commercial tests are infected with the pandemic flu virus.
Since Focus Diagnostics began to perform its laboratory developed test at its Cypress, CA, laboratory two months ago, orders placed by physicians for patients suspected of being infected with the 2009 H1N1 influenza virus increased dramatically before peaking in late June. While test volume has since declined, it remains more than 30 times higher than the company's typical rate of influenza virus testing in July.
