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| 16:12 EDT |  | DGX, MMM, MMM |
| theflyonthewall.com: | FDA issues emergency use authorization for commercial H1N1 flu test from Quest | | The U.S. FDA issued a second emergency use authorization to Focus Diagnostics, the infectious disease diagnostics business of Quest Diagnostics (DGX), for its 2009 H1N1 influenza virus test. With the EUA, Focus Diagnostics is the only company in the U.S. to offer test kits for detecting the pandemic 2009 H1N1 virus that the FDA has authorized for emergency use by CLIA high-complexity labs, which include certain hospital and regional labs. The test allows clinicians to quickly and definitively identify infected patients, differentiating from those who have similar symptoms. The new EUA authorizes Focus Diagnostics to market and offer its Simplexa Influenza A H1N1 test for use on the 3M Integrated Cycler from 3M (MMM) to CLIA high complexity laboratories for the duration of the emergency. The 3M Integrated Cycler is a microfluidic molecular diagnostic testing system and is not FDA cleared or approved. Used on the 3M platform, the test can provide increased capacity for 2009 H1N1 influenza virus testing to a wide range of CLIA-high complexity laboratories, including many hospitals, coping with a surge in testing demand. The new test offering is one outgrowth of an exclusive global distribution agreement formed between Focus Diagnostics and 3M under which Focus will develop and offer its first line of molecular diagnostic test kits, to be sold under the Simplexa brand name, on the 3M Integrated Cycler. The 2009 H1N1 influenza test kit is the first offering from the Simplexa product line, and the company plans to launch additional Simplexa test kits on the 3M Integrated Cycler for infectious diseases in 2010. :theflyonthewall.com |
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