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Patent Awarded for Detailed Pandemic Flu Detection Test

U.S. Patent and Trademark Office

U.S. Patent and Trademark Office (A. Kotok)

8 October 2014. A genomics-based test to detect various types of pandemic influenza, including mutated forms resistant to antiviral drugs, is the recipient of a recent patent. The U.S. Patent and Trademark Office awarded patent number 8,808,993 — Methods and Kits to Detect New H1N1 “Swine Flu” Variants — to three inventors, and assigned it to Translational Genomics Research Institute (TGen) in Phoenix, Arizona and Northern Arizona University in Flagstaff.

The patent covers techniques devised by TGen’s Paul Keim, David Engelthaler and Elizabeth Driebe to detect the precise strain and properties of H1N1 or swine flu virus with genomic probes called oligonucleotides from a sample of genetic material that indicate specific genomic sequences. Keim is also a biology professor at Northern Arizona.

The H1N1 flu virus caused a global disease outbreak or pandemic in 2009, but has become a recurring seasonal flu virus, and in 2014 the predominant form of flu in the U.S. Tests are available to determine if someone with flu symptoms — fever, body aches, tiredness, and cough — is infected with a flu virus, but specialized equipment available in only a few labs, such as the U.S. Centers for Disease Control and Prevention, is needed to determine more details about the virus’s strain, including its resistance to current medications. Those detailed tests are normally conducted today only for patients requiring hospitalization or at high risk from a compromised immune system.

Techniques in the patent make it possible for tests to analyze a mucus sample or respiratory swab from the patient. The test is comprised of a series of oligonucleotides that determine the sequence of nucleic acid identifiers revealing the presence of H1N1, but also the precise strain, including properties likely to be resistant to current medications, such as Tamiflu.

The techniques are designed for packaging in a test kit administered in a doctor’s office, without sending it out to a separate lab. The results are expected to give physicians a precise identification of the H1N1 virus, to prescribe an appropriate treatment. “This new test puts the power in the hands of the clinician to determine if their drugs will work or not,” says Engelthaler in a TGen statement, adding, “This is really important moving forward as we discover new strains that are resistant to antivirals.”

TGen says it expects to license the technology for development of test kits or a flu testing service.

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