“When H1N1 influenza spread from Mexico in 2009, we didn’t know how severe it was going to be,” recalled Professor Paul Keim of Northern Arizona University. “There was great fear it might cause a big increase in flu deaths over a more typical flu outbreak – because it was a new flu strain, no one had immunity to it.”
The so-called “swine flu” outbreak five years ago was pronounced a pandemic and public health emergency by the World Health Organization. Cases began appearing in late March 2009 in California and had spread to other states by the early summer; Arizona had 8,726 reported cases, 1,897 hospitalizations and 152 reported deaths. At NAU’s Campus Health Services alone, 569 students were diagnosed with an influenza-like illness that year – around 10 times the normal rate. Although symptoms are similar to more common flu strains, a sufferer is more likely to feel nauseous and throw up with swine flu. Like regular flu, swine flu can lead to serious complications like pneumonia and respiratory failure. And what many people do not realize is that H1N1 is still in circulation; in fact, it is still the most important flu strain in the United States.
“The H1N1 strain from 2009 turned out to be not as bad as we’d feared – it was in fact a relatively mild flu virus,” said Keim. But the 2009 outbreak prompted the Flagstaff research team into action. Elizabeth Driebe at TGen North came up with a test that takes just a few hours to carry out, using a swab of what are delicately described as “respiratory secretions” – which, in infected patients, contain the virus. This test uses a common molecular biology technique known as PCR to amplify a specific piece of DNA in a sample so that it can be identified. The value of this particular test is that it does not just identify whether the H1N1 virus is present – it also shows whether a very specific Tamiflu-resistant mutation is present in the virus’s RNA. That is why it will be a huge help for doctors if it can be brought to market and made widely available – because it will let physicians know whether or not giving someone the Tamiflu treatment will be effective.
“It took us only days to think up the test, a few weeks to design it, then a few months to get it validated,” Keim explained. He says that their speed was the result of the TGen team’s long experience in research with infectious diseases – and the multi-million dollar state-of-the-art laboratories in Flagstaff. The high-tech “biosafety suite” at NAU cost millions of dollars to build and costs millions more to maintain. Costs are high because of the extremely rigorous quality control and safety standards required to prevent lab workers being exposure to harmful viruses – and to prevent those viruses leaving the lab. The Flagstaff lab operates at what is known as Bio Safety Level 3 – staff wears Tyvek suits, respirators and two pairs of gloves, to prevent transmission of the virus to their nose or mouth. They also work within a whole suite of rooms with negative pressure so that no air can leave the building, until it has been filtered twice.
TGen North employs about 35 people in the labs, with another 80 people employed at NAU and the H1N1 test is just one of many genomic-based tests they are developing. “We’ve got work ongoing on MRSA (a drug-resistant bacterium that causes difficult-to-treat infections especially in hospitals, prisons, and nursing homes), as well as anthrax, plague, tuberculosis – and a big project on E. coli in food – all involving genome analysis. We file patents all the time – we’ve got between 20 and 30 pending currently,” explained Keim. These patents can be a long time in development and testing before they are approved as a commercially marketable product. But securing patents is vital to attract diagnostic companies to invest in getting the product to market. “We currently have a patent on the MRSA test and have sold the licensing rights for the assay to a company who is moving it through the approval process, as well as a test for valley fever,” said Keim. Valley Fever is a fungal disease that initially creates flu-like symptoms, which if misdiagnosed can go untreated for years with serious long-term health consequences.
The flu shot you got this year will have protection against the existing strain of the H1N1 flu in it. But all of these virus strains are constantly mutating and developing resistance to existing treatments, which is why continuous research is needed to keep pace with those genetic changes and to keep tests and vaccine formulations up to date. As well as being of academic interest and of enormous importance to public health, there is serious revenue potential too, according to Keim. “As the developers, NAU and TGen hold the intellectual property rights – these institutions then negotiate the tests’ sale with diagnostic companies. Usually, the terms involve a mixture of an upfront payment along with a royalty based on the revenues from assay sales. The details are usually kept confidential – but it can be from hundreds of thousands to millions of dollars.” There is a period of several months to several years required to run trials in certified clinical test labs, prior to final FDA review, certification and approval – so that might be big bucks, but they are not fast bucks. “I never count the money until it’s in our hands,” Keim said.
The recent public health crisis surrounding Ebola has shown just how important it is for this kind of background research, testing and vaccine development, in order to keep pace with genetically evolving diseases, Keim concludes. “With the long time lags involved, we need to be at least 10 years ahead of the next disease outbreak. Even in the middle of a crisis like the Ebola outbreak, you don’t want to give people a test or a vaccine that doesn’t work.” FBN
By Diane Hope
Flagstaff Business News
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