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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.
"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.
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.
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.
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 of approved or cleared medical products following a determination and declaration of emergency, provided certain criteria are met. In the case of the Influenza A H1N1 (2009) Real Time RT-PCR, the FDA has only authorized its use for the duration of the declaration of emergency, which is currently set to expire on April 26, 2010, unless it is terminated, revoked sooner or renewed.