"Innovation often emerges in response to crisis, and the 2009 H1N1 is no exception," said John G. Hurrell, Ph.D., vice president and general manager, Focus Diagnostics. "When 2009 H1N1 surfaced about a year ago, limitations in traditional flu tests made them unsuitable for dealing with a virus infecting large swaths of the population. These limitations included the sensitivity of rapid tests and the need to ship samples to reference labs with reliable PCR methods. We designed our Simplexa 2009 H1N1 test to overcome these problems by bridging highly reliable PCR with testing technologies that many hospital labs can perform in-house."

"Moreover, FDA clearance of our Simplexa test means hospital and other labs can use our test with confidence since it meets regulatory requirements long term, unlike flu tests authorized for 2009 H1N1 emergency use testing until late June," added Hurrell.

Focus Diagnostics has led the diagnostics industry in the development of new 2009 H1N1 influenza testing technologies. It was the first company to receive emergency use authorization from the FDA for a commercial H1N1 2009 test and the first company to launch a commercial test kit for qualitatively detecting RNA of the H1N1 2009 virus by RT-PCR.

SOURCE Quest Diagnostics Incorporated