TGen seeks emergency FDA approval of new swine flu test

H1N1 testing data presented at Infectious Diseases Society of America conference

FLAGSTAFF, Ariz. – Oct. 29, 2009 – 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.

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Currently, only the U.S. Centers for Disease Control Prevention (CDC) and a few select labs can look for resistance, using cumbersome and time intensive technology, Engelthaler said.

"This new test would put the power in the hands of the clinician to determine if their drugs will work or not. This is really important moving forward. When this outbreak first started (in April), everything was 100 percent sensitive to Tamiflu. But now, we're starting to see isolated cases of resistance pop up,'' Engelthaler said.

The World Health Organization has identified more than three-dozen instances of resistance to Tamiflu in the H1N1 swine flu virus.

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"The novelty in our study is the use of increasingly common laboratory tools to rapidly and accurately detect resistance to anti-influenza drugs. Until now, nearly all this work has required highly sophisticated laboratory procedures not readily available to most clinical labs and has really only been used for broad public health surveillance,'' Engelthaler said. "Our testing procedure measures very minute amounts of virus and minute changes to the virus. Not only does it detect when resistance is occurring, but it also detects it at the earliest onset possible."