07 Apr EraGen's SARS test validated by Chinese agency
MADISON – EraGen Biosciences, a Madison-based genetic diagnostics and drug discovery company, announced Tuesday that the Chinese Center for Disease Control and Prevention has validated its molecular diagnostics in writing. EraGen President and CEO Irene Hrusovsky showed the company’s SARS diagnostic test to Beijing officials while on Gov. Jim Doyle’s recent Wisconsin Trade Mission to China.
The company enlisted the aid of Medical Quality International, a medical and pharmaceutical consulting group, to communicate with the Chinese CDC. MQI was founded to help U.S. medical and drug companies market their products in China, taking into account the different requirements of Chinese and U.S. regulatory agencies.
The validation study came after last year’s epidemic of SARS, or severe acute respiratory syndrome, a fatal disease that appeared in China in mid-March and spread quickly as far as Toronto, Canada. EraGen introduced the first SARS test in the United States.
“The EraGen SARS test, one of the few real-time PCR systems in the world, offers unique features that provide high sensitivity and quantitative testing for the SARS virus, while eliminating many traditional difficulties of other RT-PCR methods such as false positive and false negative outcomes as well as no cross reference features,” said Fred Ma, president and CEO of MQI. “During the validation study, the advantages of these features were proven and were highly recognized by the scientists and officials in the Chinese CDC.”
Hrusovsky said the trade mission was a productive way of making contacts in China, as well as securing the validation.
“I found the Trade Mission agenda very valuable, enabling me to secure EraGen’s validation report from the Chinese CDC and to hold meetings with diagnostic, genomic and drug discovery companies for potential business partnerships,” she said. “I was also able to visit with the Chinese operation of Promega, our new Madison business partner. As a result of this trip, I can see that China will be an excellent opportunity in our global business strategy.”
Ma added, “The success of this study is not only significant in validating EraGen’s technology, but it also opens the door for further cooperation with both the Institutes of Virology and of Communicable Diseases in the Chinese CDC for use of EraGen’s technology in future diagnostics of infectious and communicable diseases in China.”
Doyle’s trade mission in March lasted 12 days, taking the largest trade delegation in Wisconsin history through Beijing, Shanghai, Nanjing and Hong Kong. Doyle called the mission an attempt to bring the “Made in Wisconsin” label to China, to which Wisconsin has increased its exports by more than 50 percent in the last year, according to a statistic from the governor’s office.
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Jason Stitt is a staff writer for the Wisconsin Technology Network and can be reached at jason@wistechnology.com.