Seegene joins multi-test trendRockville company’s product is used to diagnose flu and other ailmentsSeegene of Rockville sees a big U.S. market for its respiratory test that can quickly and simultaneously pinpoint the genetic material of 18 different viral or bacterial pathogens. Seegene Inc., the six-employee U.S. branch of Seegene of Seoul, South Korea, plans to apply for approval of its Seeplex 18-Plex Respiratory Test with the U.S. Food and Drug Administration next year and apply for a U.S. patent, said company manager Jessica Joung. The test, already patented in South Korea, will enter production next month. The company says its test is superior to others on the market, because it ‘‘doesn’t generate false positives [which] is a major problem with others,” Joung said. Seegene is seeking a partner to distribute the test in this country and already has a ‘‘reference partner” for developing its multiplex test for sexually transmitted diseases. ‘‘Our new 18-Plex Respiratory Test is what the clinical health care industry has been asking for — the ability to routinely test for a wide spectrum of respiratory pathogens in a single test, at the price of a single pathogen test,” Jong-Yoon Chun, Seegene founder and CEO, said in a statement. Developing such multiplex testing recently has caught fire in research and development at the National Institute of Allergic and Infectious Diseases. Multiple pathogen diagnostics ‘‘is the direction people are taking,” said Karen A. Lancaster, program officer in basic influenza research at the institute. While not commenting on the Seegene’s proposed test, Lancaster said, ‘‘In this pre-pandemic period, it is particularly important to have the surveillance methods in place to prevent [flu] spread and to also produce new vaccines.” Seegene, founded in 2000, offers molecular diagnostics services to more than 1,000 major institutes in more than 25 countries, according to its Web site. Earlier this year, the company also announced a similar test for multi-testing for human papillomaviruses, which can cause cervical cancer. In May, bioscience company BioServe of Beltsville and Hyderabad, India, announced it was partnering with Seegene to develop, validate and service new test systems for infectious diseases in India. The Seeplex respiratory test can detect DNA or RNA from any of 13 major respiratory infection viruses and five respiratory infection bacteria, but not tuberculosis, Joung said. The new test will be ‘‘a breakthrough” in how hospitals and other medical centers test patients exhibiting flu-like symptoms, she said. The problem solved by such tests is that many different pathogens, especially those causing new infectious diseases, such as new flu strains, don’t have signature symptoms, according to Maria Y. Giovanni, an assistant director at the infectious disease institute’s division of microbiology and infectious diseases. ‘‘If a patient doesn’t have flu, what do they have? Of course, that is where the field is going,” Giovanni said. Lancaster and Giovanni are agency spokeswomen for the GreeneChip, a diagnostic device made public in December that tests for thousands of different viruses, bacteria, fungi and parasites from samples of human fluid and tissues. The GreeneChip was funded by the National Institutes of Health and developed by researchers at the Greene Infectious Disease Laboratory at Columbia University’s Mailman School of Public Health and the World Health Organization’s Global Laboratory Network. ‘‘Multiplex detects what you need, such as multiple influenza and strains,” Lancaster said. ‘‘Once you have the platform you can decide on what pathogens to go after.” Privately held Seegene, which declined to disclose financial information, changed its business plan last year to become a molecular diagnostic company, Joung said. It had previously operated strictly as a testing laboratory. ‘‘In Korea we had major good collaboration with many hospitals and major medical universities,” she said. ‘‘You name it, we worked with them.” Seegene is setting up an independent company in the United States for tax reporting and registering its intellectual properties.
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