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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

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.

About Focus Diagnostics

Focus Diagnostics, Inc. is an infectious disease diagnostics company, providing infectious disease reference laboratory services to hospitals and laboratories nationwide, and manufacturing and distributing diagnostic products worldwide. Focus Diagnostics develops innovative tests and products to assist physicians in diagnosing infectious diseases, and often provides the first diagnostic tests in the U.S. for emerging diseases, such as West Nile Virus and SARS. HerpeSelect(R) type-specific HSV serology and West Nile Virus DxSelect(TM) are top-selling Focus Diagnostics products used in laboratories worldwide. Focus Diagnostics is a wholly owned subsidiary of Quest Diagnostics.

Focus Diagnostics has collaborated with the U.S. Centers for Disease Control and Prevention, the World Health Organization and other public health agencies to help identify and develop diagnostic tests for emerging infectious diseases. Focus Diagnostics was instrumental in developing the first laboratory developed test for West Nile virus after it was identified in New York in 1999. Focus Diagnostics also introduced the first laboratory developed test for SARS and one of the first FDA-cleared serological test kits for Lyme disease.

Visit www.focusdx.com for additional information.

About Quest Diagnostics

Quest Diagnostics is the world's leading provider of diagnostic testing, information and services that patients and
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SOURCE Quest Diagnostics Incorporated
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