991101 IGEN Launches PATHIGENE. Coli O157 TestNovember 1, 1999Gaithersburg, MD - IGEN International, Inc. announced the launch of its PATHIGEN E. coli O157 Test at the International Meat Exposition in Chicago. This is the first product launched by Company's Industrial Business Unit for food testing. Developed by the USDA's Agricultural Research Service (ARS) based on IGEN's patented ORIGEN technology, the test has demonstrated an unprecedented level of sensitivity and precision in detecting this dangerous strain of the food-borne pathogen. The new test for detecting E. coli O157, is a semi-automated method that offers rapid results and is estimated to be up to 100 times more sensitive than any other test on the market. Commonly used methods of detecting the dangerous pathogen in meat products often fail to pick up low levels of contamination. Existing detection methods also lead to a high number of false positives, often causing the unnecessary disposal of tons of ground beef. "We have developed a test we believe is far more accurate and sensitive than anything currently available," said Jerry Crawford, the USDA's ARS research chemist who developed the test. "Ultrasensitivity is a critical attribute because of the need to detect E. coli O157 at any level present in meat and other food products. We can have results from this new assay rapidly, while reducing the number of false positives and accurately detecting low levels of contamination in samples. This compares with 24 to 48 hours for traditional microbiological assay results." E. coli O157 is a strain of the bacteria known to cause serious gastrointestinal illness, usually when encountered in contaminated ground beef that has not been properly cooked. Outbreaks of E. coli O157 related illness have also been associated with the consumption of raw milk, tainted water and certain fruits and vegetables. Although symptoms of E. coli O157 infection typically disappear in 5-10 days, some people -- especially the very young and elderly -- may contract hemolytic uremic syndrome, which can result in kidney failure and even death. About 60,000 cases of E. coli O157 infection are reported each year in the US. IGEN has a complementary panel of tests currently under development to more accurately and efficiently detect other food and water pathogens, including tests for Salmonella, Listeria, Campylobacter and Cryptosporidium parvum. "Many people have worked to move this product from a laboratory test to a commercialized product, and we are extremely pleased and excited to be bringing the PATHIGEN E. coli O157 test to market," commented Samuel J. Wohlstadter, Chairman and CEO of IGEN. "This test gives commercial food processors and regulatory agencies a powerful new tool to test for E. coli O157 by a highly sensitive, accurate and specific test, while contributing to the safety of foods consumed every day by the public." Earlier this year IGEN signed a Cooperative Research and Development Agreement (CRADA) with the USDA with the goal of adapting the new E. coli O157 test to a commercialized product, as well as developing other important food and beverage pathogen tests. The ARS' goal for the collaboration is to provide government regulatory agencies and commercial food processors with rapid methods to more accurately detect dangerous pathogens in public food and water supplies. The PATHIGEN test represents the second product IGEN has commercialized in 1999. Earlier this year the Company launched its new M-SERIES(TM) System for use by biopharmaceutical companies in drug discovery and research. Through its Life Science, Industrial and Medical business units, IGEN develops, manufactures and markets diagnostic systems utilizing its patented ORIGEN technology, which is based on electrochemiluminescence. The ORIGEN technology provides uniform assay formats for conducting a multitude of diagnostic tests, including immunoassay, nucleic acid probe and clinical chemistry tests. Products using the ORIGEN technology include systems marketed by IGEN and its licensees, Roche Diagnostics, Organon Teknika and Eisai.
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