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A new diagnostic tool that might play an important role in rapidly detecting viruses that cause avian flu and other respiratory illnesses is close to passing a validation test being conducted at University of Wisconsin Hospital and Clinics.
The MultiCode panel technology, which is being developed by EraGen Biosciences
, a Madison biotechnology company, received the "thumbs up" Wednesday from James E. Gern, professor of pediatrics at UW-Madison. Gern, a pediatric allergist and immunologist, is conducting research on respiratory viruses that influence acute asthma in children.
The path to commercialization for the MultiCode panel, which can detect multiple viruses in one test, includes the validating trials now underway. "We're pretty much done [with validation testing]," Gern said. "We're satisfied that we're getting accurate results from the study, and we're still doing some fine tuning, which will probably continue."
The technology attracted interest at both of EraGen's presentations at the recent BIO 2006 Conference in Chicago. On Wednesday, a poster was presented which featured EraGen products in the context of responding to a flu pandemic, but Peter Donahue, director of product development for EraGen, could not pinpoint when the respiratory panel will hit the market. He said evaluations are taking place at three other major laboratories in the United States.
"Currently, we do have customers participating in an early access program and would estimate that should a crisis arise, we could have research use products ready immediately," Donahue said. "Our initial customers would be large hospital laboratories skilled in molecular diagnostics."
Gern said the technology that UW Hospital and Clinics is working with picks up "in the range of 200 different viruses." While not exactly the same as the product EraGen eventually will bring to market, the UW is employing the same technology. Gern characterized the system as one that is very flexible, offers researchers a comprehensive way to look for respiratory viruses, and can be customized for use in healthcare facilities and diagnostic labs.
The MultiCode panel not only looks for multiple respiratory pathogens in one test, it reduces diagnostic time from weeks to hours, minimizing the need for traditional, and lengthy, culture methods. In addition to testing for avian flu, severe acute respiratory syndrome (SARS), and asthma, it also has applications for pertussis, more commonly known as whooping cough. SARS, a viral respiratory illness, killed 774 of the more than 8,000 people who contracted it during a 2003 outbreak.
In the current context, Gern believes the development of a diagnostic product with the ability to simultaneously scan for a range of infectious agents could make EraGen the area's next great biotech success story. Scientists worldwide are trying to limit the spread of the avian or "bird flu" virus, which thus far has killed at least 100 people in Asia, Africa, and Europe. In the precedent setting "Spanish flu" pandemic of 1918, a powerful strain of influenza killed more than 40 million people, including roughly 700,000 people in the U.S.
EraGen, which reported $4 million in revenue in 2005 and has 33 employees, could see those numbers expand as national governments scramble to find out who has the disease. Although its immediate market is within the United States, Donahue confirmed that EraGen is involved in discussions with international health experts. In late March, the company participated in a policy dialogue in Brussels with officials from both the European Union and the U.S.
Gern said the flexibility of the EraGen platform - scientists can add new viruses to the panel - will help researchers stay ahead of the curve in detecting new viruses. One example of a new virus is the human bocavirus, which can cause respiratory illnesses that are serious enough to require hospitalization. Recently, it was found in nearly 5 percent of pneumonia patients in rural Thailand, most of them young children.
"One thing that has happened in the past couple of years is that there have actually been some new viruses discovered, and it's pretty amazing that we're still pulling out new viruses," he said. "They seem to be important causes of illnesses in kids, so we're working to add some of these newer viruses to the [EraGen] panel."
Gerda Harms, a research scientist for EraGen, noted the company helped researchers keep up with SARS. "With our MultiCode-PLx test, when some viruses mutate, it is easy to modify existing systems," she explained. "In this way, laboratories using our MultiCode system can easily stay ahead of the curve."
Founded in 1999, EraGen also has developed tests for HIV and anthrax, and its work thus far has attracted $21 million from venture investors.
Outside the viral realm, EraGen has collaborated with organizations like the Blood Center of Wisconsin. The center's diagnostic labs conduct specialized tests on patient samples to match potential organ donors, detect risk factors for cancer and heart disease, and identify bleeding and clotting disorders.
Brian Curtis, technical director for the center's Platelet and Neutrophil Immunology Laboratory, said EraGen's multi-panel diagnostic tools have been applied in electro-genetic tests on blood samples. "You can apply this multi-code platform to any kind of typing you want to, as long as you design it to be able to do that," Curtis explained.
He said the blood center now could work on as many as 42 patients in half a day, whereas it would take days or weeks to do that with previous methods.