TGen to submit H1N1 test for emergency use
This article was originally published in Clinica
Executive Summary
The Translational Genomics Research Institute (TGen) is to submit its H1N1 test to the US FDA under an emergency use authorisation (EUA). As well as detecting the flu virus, the test can identify the strain and discern whether it is likely to be resistant to the antiviral drug Tamiflu. It is the only resistance test available that uses a standard molecular technique to make exact copies of components of the H1N1 virus' genetic material, the Phoenix, Arizona-based non-profit organisation claims. Currently, only the US Centers for Disease Control and Prevention (CDC) and "a few select labs" can look for resistance, it added. TGen developed the test with molecular diagnostic firm PathoGene.
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