Second emergency use authorization granted for a Quest H1N1 flu test
This article was originally published in The Gray Sheet
Executive Summary
A second emergency use authorization request is granted to Quest's Focus Diagnostics unit by FDA Oct. 16 for an H1N1 influenza test. This one will allow Quest to market and offer its Simplexa Influenza A H1N1 (2009) test for use on the 3M Integrated Cycler. FDA granted an EUA July 24 to Quest for its Focus Diagnostics Influenza H1N1 (2009) real-time reverse transcription polymerase chain reaction test (1"The Gray Sheet" July 27, 2009). While 3M's Integrated Cycler diagnostic testing system is not FDA cleared or approved, when the Simplexa test is used on the 3M platform, it can provide increased capacity for 2009 H1N1 flu testing to a wide range of CLIA high-complexity laboratories, including hospital labs coping with a surge in testing demand this fall