Quest Diagnostics Inc. announced that FDA has issued 510(k) clearance to the Simplexa Influenza A H1N1 (2009) test on the 3M Integrated Cycler. The Simplexa test, developed and manufactured by Quest Diagnostics' Focus Diagnostics business, is the first to be cleared by FDA for use as an aid in the detection and differentiation of influenza A and 2009 H1N1 influenza viral RNA.

The Simplexa Influenza A H1N1 (2009) test runs on the 3M Integrated Cycler under an exclusive global distribution agreement between Focus Diagnostics and 3M.  The test employs real-time reverse transcription (RT) polymerase chain reaction (PCR) to qualitatively detect RNA of the 2009 H1N1 flu virus (2009 H1N1) in a patient's nasal or nasopharyngeal specimens. It reports if a specimen is positive or negative for the presence of 2009 H1N1 or influenza A virus. By comparison, some flu tests, including rapid point-of-care influenza tests, can detect the presence of influenza A, but not differentiate the presence of 2009 H1N1. In addition to 2009 H1N1, influenza A viruses include some seasonal flu subtypes.