TGen seeks emergency FDA approval of new swine flu test

– The Phoenix-based non-profit Translational Genomics Research Institute (TGen) announced today that, along with a business collaborator, it will submit a request to the U.S. Food and Drug Administration for emergency use of a new test to diagnose the 2009 H1N1 swine flu virus.

Details about TGen's test will be presented Sunday (Nov. 1) at the 47th annual meeting of the Infectious Diseases Society of America (IDSA), being held today through Sunday (Oct. 29-Nov. 1) in Philadelphia.

The new test, developed at TGen's Pathogen Genomics Division (TGen North) in Flagstaff, can not only detect influenza — as some tests do now — but also can quickly inform doctors about what strain of flu it is and whether or not it may be resistant to oseltamivir (sold under the brand name Tamiflu®; Roche), the primary anti-viral drug on the market to treat H1N1.

As with other influenza strains, H1N1 flu can be expected to show signs of resistance to oseltamivir, and new treatments will be needed to respond to this and future pandemics.

"The problem with influenza is that it is becoming resistant to the antiviral drugs that are out there,'' said Dr. Paul Keim, a Professor of Biology at Northern Arizona University and Director of TGen North. "Because it is a virus, it mutates easily and becomes resistant.''

David Engelthaler, Director of Programs and Operations for TGen North, said this would be the only resistance test available that uses a standard molecular technique that rapidly makes exact copies of specific components of H1N1's genetic material.

"So far, it looks like this assay is very effective with strains in the U.S., and we expect it to have the same accuracy with strains around the world,'' said Engelthaler, the former State Epidemiologist for Arizona and former State of Arizona Biodefense Coordinator.

The assay, or test, for H1N1 flu was developed by TGen and a company called PathoGene LLC, which is a partnership that includes a group of Flagstaff business people as well as Engelthaler and Keim.

via TGen seeks emergency FDA approval of new swine flu test.