Kramer,
I would think that Igen's tests for food-borne pathogens will eventually become standard. I believe a listeria test is under development by them.
Here's a release from last month:
IGEN International, Inc. (ticker: IGEN, exchange: Nasdaq) News Release - Thursday, April 13, 2000
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IGEN Technology Used by U.S. Army, Meat Industry in Pathogen Tests; New Applications Illustrate Origen(R) Technology's Broad Utility
GAITHERSBURG, Md., April 13 /PRNewswire/ -- Using the patented ORIGEN(R) technology developed and marketed by IGEN International, Inc. (Nasdaq: IGEN), the U.S. Army Medical Research Institute of Infectious Diseases (USAMRIID) has developed a new test for staphylococcal enterotoxin B (SEB), a major cause of food poisoning and a possible biological warfare agent. In a published scientific paper, the USAMRIID researchers reported that the ORIGEN-based test was "significantly better" than the current standard test for such toxins.
In a separate development, IGEN announced that a business unit of one of the nation's largest beef packers signed an agreement to purchase IGEN's new PATHIGEN(TM) E. coli O157 test, which detects a strain of bacteria responsible for numerous food poisoning outbreaks.
"The USAMRIID paper and the order for the E. coli O157 test are further examples of how broadly our ORIGEN technology is being applied," said Samuel J. Wohlstadter, IGEN's Chairman and Chief Executive Officer. "The technology is also being used in clinical diagnostic testing and drug discovery and development. This broad acceptance is further confirmation that ORIGEN technology has several unique properties that make it readily adaptable for sensitive detection and accurate measurement of a wide range of substances in many different kinds of samples and under many different conditions."
SEB Test
SEB is a toxin produced by a strain of the bacterium Staphylococcus aureus. According to the U.S. Centers for Disease Control and Prevention (CDC), this and other staphylococcal toxins cause an estimated 185,000 cases of food poisoning each year in the United States.
The USAMRIID researchers said that SEB toxin represents a significant biological weapons threat. An enemy could release airborne toxin that can cause incapacitating illness within a few hours. SEB could also be used to contaminate food or water supplies.
USAMRIID needed a test for SEB that would detect minute quantities of the toxin in a variety of samples, such as food, water, blood, and urine. It also needed a highly specific test, because the presence of other biological substances can confound test results. Finally, the Army wanted a test that is quick and easy to perform, because of the need to conduct tests in combat and emergency situations.
In the article (Journal of Immunological Methods, Volume 236, Issue 1-2, March 6, 2000, pp. 9-17), USAMRIID scientists reported that they used the ORIGEN-based test on 111 samples from serum, tissue homogenates, urine, and skim milk. They concluded the new test is "significantly better" in terms of sensitivity, simplicity, and speed than the standard testing method, an enzyme-linked immunosorbent assay. They said that the new test "should permit early SEB detection in clinical samples, food, and environmental samples."
IGEN plans to develop its own test for staphylococcal enterotoxins. This new test will be incorporated into a panel with the company's current E. coli O157 test and later with tests under development for the detection of a variety of other food and waterborne pathogens, including Salmonella, Listeria, Campylobacter and Cryptosporidium parvum.
E. coli O157 Test
The O157 strain of E. coli can cause serious gastrointestinal illness, usually as a result of consumption of contaminated ground beef. 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 five to ten days, some people- especially children and the elderly -may contract hemolytic uremic syndrome, which can result in kidney failure and even death. According to the CDC, E. coli O157 infection causes an estimated 73,000 cases of illness and 60 deaths each year in the United States.
In 1999, IGEN signed a Cooperative Research and Development Agreement with the U.S. Department of Agriculture's (USDA) Agricultural Research Service to develop the PATHIGEN E. coli O157 test into a commercial product, as well as to develop other important food and beverage pathogen tests. The USDA's goal for the collaboration is to provide government regulatory agencies and commercial food processors with rapid methods to detect more accurately pathogens in public food and water supplies.
Based on IGEN's ORIGEN technology, the PATHIGEN test is estimated to be up to 100 times more sensitive than other E. coli O157 tests on the market. High sensitivity is a critical attribute because of the need to detect E. coli O157 in food products even when it is present at low levels. Commonly used methods of detecting the pathogen in meat products often fail to pick up low levels of contamination.
The PATHIGEN test's format provides other advantages over conventional methods. Its semi-automated operation allows users to archive data so that production lots can readily be traced. The PATHIGEN test is easy to perform because it uses a convenient dropper bottle format and all reactions occur in a single test tube.
IGEN develops and markets products that incorporate its proprietary ORIGEN technology for detection and measurement of small molecules, proteins, nucleic acids, bacteria and viruses in any kind of clinical or environmental sample. ORIGEN technology is being applied to drug discovery and development, clinical diagnostic testing, and food and environmental testing. It provides a unique combination of speed, sensitivity and flexibility for a wide range of tests on a single technology platform. Products using ORIGEN technology are marketed by IGEN and its licensees, Roche Diagnostics, Organon Teknika and Eisai Company. More information about IGEN can be found at igen.com.
Peter
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