Quest Diagnostics Incorporated (NYSE: DGX), the world's leading provider of diagnostic testing, information and services, today announced that the U.S. Food and Drug Administration (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 the 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 ( MMM). 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.
"Thankfully, H1N1 is not currently a widespread public health problem, but reliable detection continues to be important to help manage high-risk patients, such as expectant mothers who have flu-like symptoms," said Jay M. Lieberman, M.D., medical director, infectious diseases, Quest Diagnostics and Focus Diagnostics. "Influenza viruses are unpredictable, and reliable tests will be needed, particularly if, as expected, 2009 H1N1 activity again increases later this year."