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Quest Diagnostics Inc And 3M Co Launch FDA-Cleared Simplexa Test on 3M Cycler For Molecular Influenza And Respiratory Virus Testing By Moderate Complexity Healthcare Facilities


Tuesday, 9 Oct 2012 12:28pm EDT 

Focus Diagnostics, a business of Quest Diagnostics Inc And 3M Co announced that the U.S. Food and Drug Administration (FDA) has provided 510 clearance and CLIA moderate-complexity categorization to the Simplexa Flu A/B & RSV Direct test on the 3M Integrated Cycler. The new test aids in the qualitative detection and differentiation of RNA of influenza A and B viruses and respiratory syncytial virus (RSV), common causes of respiratory illness. Focus Diagnostics, maker of the Simplexa brand of molecular test kits, and 3M, maker of the 3M Integrated Cycler technology, developed the test through an exclusive global collaboration. The collaboration, formed in 2009, has produced several Simplexa molecular tests, including the first FDA-cleared commercial test for the influenza A H1N1 (2009) virus. Moderate complexity laboratories, defined by the Clinical Laboratory Improvement Amendments (CLIA), include certain types of physician's offices, community hospitals, health clinics and integrated delivery networks. 

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