WisBusiness: Madison Company Could Be Key in Diagnosing Bird Flu

By Brian E. Clark

WisBusiness.com

MADISON – In 1918, a powerful strain of influenza swept the globe, killing more than 40 million people. In the United States, as many as 700,000 people died from what was known by many as the “Spanish Flu.”

That pandemic threat lingers in the background as scientists work to understand, detect and treat the bird flu virus that has moved from Asia to Africa and now Europe – killing at last 100 people in the process.

Few doubt that it will eventually reach this continent.

EraGen Biosciences, a small Madison diagnostic company, may play a major role in figuring out just who has the disease, both here and abroad.

“There is a precedent for a worldwide pandemic,” said Irene Hrusovsky, president of EraGen. “That’s what people are afraid of and why we need to be prepared.”

She said respiratory infection tests being developed by EraGen could quickly screen large numbers of patients for a wide array of diseases. The tests could also mean millions of dollars in revenue for the start-up, which had roughly $4 million in revenue last year.

“We have developed testing systems for anthrax, SARS and influenza,” said James Prudent, EraGen’s chief scientific officer.

“Now … we can scan for large numbers of infectious agents simultaneously, which will be essential if a true pandemic ever materializes,” he said.

EraGen, a privately held company, has 33 employees and in January raised $12 million from investors, for a total of $21 million since its 1999 founding. It is located on Deming Way on Madison’s west side. EraGen is also one of a half-dozen Wisconsin companies that will give presentations at the Wisconsin Discovery Theater at next week’s huge BIO 2006 conference in Chicago.

UW-Madison pediatrics professor and asthma expert James Gern, who has collaborated with EraGen, called the company’s tests a “big advance both in terms of time and sensitivity.

“They do good work and they have developed some adaptive new technology that can be used for a number of purposes and look for all respiratory viruses in one test,” he said.

Peter Shult, who directs the communicable disease division of the state Hygiene Laboratory, also had high praise for EraGen’s respiratory illness test. Shult is also in charge of pandemic preparedness for the state

“The fact that it (EraGen’s test) is a panel allows us to test for multiple pathogens at the same time, representing a considerable savings in turnaround time, staff time and overall costs,” he said in an e-mail.

“Results to date have been very favorable. EraGen’s test seems to be very sensitive and specific and also enable us to look for viruses we have been unable to detect previously.

“If these results are borne out with further evaluation we would, indeed, likely incorporate it into our diagnostic menu. We are very excited about this! Hopefully this would occur to at least some extent by next influenza season, which begins in November,” he concluded.

In Wisconsin alone, officials have said the bird flu has the potential to kill as many as 8,000 people – if it mutates to a form that can spread quickly among humans.

“No one really knows how big a problem it will be,” said Prudent.

“If lots of people die, it’s big, that’s what it comes down to,” he said bluntly.

Congress is taking the threat seriously and has appropriated $3.8 billion to deal with the bird flu threat. Wisconsin should receive nearly $2 million of the $350 million set aside for state and local governments, according to published reports.

“The vast majority of dollars has gone for vaccines and infrastructure,” said Hrusovsky, a physician and former president of the board of the Wisconsin Biotechnology and Medical Device Association.

“But now diagnostic testing is coming to the forefront because of avian flu. That’s where we come in.”

Prudent said Wisconsin is one of the top research centers for flu research, thanks to the efforts of scientists such as Yoshihiro Kawaoka and Chris Olsen of the UW-Madison veterinary medicine school. Kawaoka will head the new $9 million Institute for Viral Research, which is slated to open next year.

The state Laboratory of Hygiene also will become one of two centers in the country to test if flu samples are resistant to antiviral drugs. The lab is now in charge of disease surveillance for the entire state and works closely with the Centers for Disease Control. And the U.S. Geological Survey’s National Wildlife Center here will be testing migratory birds to see if they are carrying the flu virus. That effort is headed by Hon Ip, director of the USGS Diagnostic Virology Lab.

Hrusovsky and Prudent said they hope to have the validating trials done and the front-line tests on the market by the end of this year. Clinical testing labs would be the primary market for the product, they said.

“With concern over asthma, pertussis (whooping cough) and avian flu, the market has to expand,” Hrusovsky said. “And there should be a growing need across a wide variety of applications.”

Added Prudent, “If the government decides to increase surveillance, it could mean a lot of revenue for EraGen.”

Hrusovsky said EraGen’s products also can play a growing role in biodefense, AIDS and hepatitis testing. The company recently received a Frost & Sullivan Product Innovation award for Genetic Testing for Multicode.

In the past few years, the company has developed the technology used by Bayer for an HIV test that has been approved by the U.S. Food and Drug Administration.

EraGen also has signed a number of licensing deals, including one with Fitchburg-based Promega Corp. that gives Promega exclusive rights to assays that measure expressions of nucleic acids.