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2009 H1N1 flu test from Quest Diagnostics at Medica

Quest Diagnostics Inc, the world's leading provider of diagnostic testing, information and services, announced that the Simplexa Influenza A H1N1 (2009) test developed by its Focus Diagnostics business has been CE marked and is now available as a test kit for distribution to approximately 35 countries in Europe. Focus Diagnostics is showcasing the test at Medica 2009, November 18 to 21, 2009, at the Dusseldorf Fair Trade Centre.

The Focus Diagnostics Simplexa Influenza A H1N1 (2009) test employs real-time reverse transcription polymerase chain reaction (RT-PCR) to qualitatively detect the 2009 H1N1 flu virus in a patient's nasal or nasopharyngeal specimens. The test targets a region of the hemagglutinin gene of the 2009 H1N1 influenza virus specifically to detect the presence of 2009 H1N1 influenza RNA, thereby differentiating it from seasonal human influenza A viruses. The World Health Organization (WHO), which provides guidance for countries managing the pandemic, states that RT-PCR is the "only rapid diagnostic test for which a positive result is accepted as confirmation" of human infection with the 2009 H1N1 pandemic virus.

The Focus Diagnostics Simplexa Influenza A H1N1 (2009) test is an outgrowth of an exclusive global distribution agreement between Focus Diagnostics and 3M (NYSE: MMM) under which Focus will develop and offer molecular diagnostic test kits, to be sold under the Simplexa brand name, on the 3M Integrated Cycler. The 3M Integrated Cycler supports real-time polymerase chain reaction (PCR) technology and employs advanced data management software to help laboratories process, store and transfer data quickly and effectively. It can process up to 96 samples per run, and provides results in 30 to 85 minutes, depending on the test's parameters. It has a small laboratory footprint, at approximately 31 centimeters (12 inches) high and 31 centimeters long.

The Simplexa Influenza A H1N1 (2009) test, which was launched in October 2009, is the first offering from the Simplexa product line. Focus Diagnostics plans to launch additional Simplexa test kits on the 3M Integrated Cycler for infectious diseases in 2010, pending required regulatory clearances.



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