IGEN's collaboration with U.S. Army on toxins is being fast tracked

IGEN is stepping up its collaboration with the U.S. Army in an effort to develop tests, based on IGEN's technology, that can rapidly detect food-, water-, and environmentally borne toxins.

Biological detection products may be used to detect waterborne toxins

GAITHERSBURG, Md., Oct. 12, 2001 — IGEN International Inc. announced today that its Cooperative Research and Development Agreement (CRADA) with the U.S. Army Medical Research Institute of Infectious Diseases (USAMRIID) is receiving additional emphasis in an effort to develop tests, based on IGEN's proprietary ORIGEN® technology, that can rapidly detect food-, water-, and environmentally borne toxins.

The company anticipates that successful completion of this CRADA would lead to expanded sales of instrumentation and reagents.

The company believes that the faster-than-expected pace of the program is attributable to the superiority of ORIGEN technology, including the high- throughput that is achievable with the IGEN M-SERIES™ M8 analyzer. Use of the M8 analyzer allows for more samples to be processed and analyzed at one time. In addition, ORIGEN technology allows for rapid assay design and optimization, decreasing the time required to develop and implement a functional test.

In the past two years there have been a number of published works by military researchers on the results of using electrochemiluminescence for the detection of biological agents, including anthrax. The company believes that this research has led to the successful implementation of ORIGEN technology for biological agent testing and has been the reason for the faster than expected pace of the current activity. ("Detection of biological threat agents by immunomagnetic microsphere-based solid phase fluorogenic- and electro-chemiluminescence," Biosensors & Bioelectronics 14:829-840; "In vitro selection of DNA aptamers to anthrax spores with electrochemiluminescence detection," Biosensors & Bioelectronics 14:457-464; and "Sensitive and Rapid Identification of Biological Threat Agents," Annals New York Academy of Sciences 894:130-148).

In one publication, USAMRIID stated that, "ECL-based agent identification is by far the most sensitive affinity-based diagnostic technology that we have tested to date. ... this technology will prove itself to be an important component of an integrated approach to identification of potential biological weapons, both in the lab and in the field."

"We are very encouraged by the rapid progress of the program and are eager to help," said Samuel J. Wohlstadter, IGEN's Chairman and Chief Executive Officer. "Based on published results and our own work, we expect IGEN will be able to provide military and public health officials with reliable, cost- effective instruments and reagents that could enhance the nation's protection against disease caused by biological agents, whether spread by natural means or as a result of an attack or act of war."

Scientists at USAMRIID working with IGEN through a CRADA are developing ORIGEN-based tests for a wide range of infectious and non-infectious biological agents. Another objective of the CRADA is to develop products that can be used by government agencies, food processors, and commercial analytical laboratories.

In addition to the work being undertaken at USAMRIID under the CRADA, researchers at two additional government laboratories, the U.S. Army Aberdeen Proving Ground research facility and the Centers for Disease Control and Prevention (CDC), have acquired IGEN's ORIGEN technology for research and assay development for detecting pathogens which are categorized by the CDC as Category A and Category B biological agents. Included in these two classes of biological agents are those food, water, and air borne pathogens that pose high risk to the population because they are easy, or moderately easy, to disseminate or transmit from person-to-person, e.g. Clostridium botulinum, Escherichia coli O157, Salmonella, and Staphylococcus enterotoxin B.

IGEN develops and markets biological detection systems based on its proprietary ORIGEN technology, which provides a unique combination of sensitivity, reliability, speed, and flexibility. ORIGEN-based systems are used in a wide variety of applications, including clinical testing, life science research, and food and environmental safety testing. These systems are marketed by IGEN and its licensees and/or distributors-Roche Diagnostics, Organon Teknika, Eisai Co. Ltd., Sumitomo Corp., and Sanko Junyaku Co. Ltd. IGEN and ORIGEN are registered trademarks of IGEN International Inc. More information about the company can be found at http://www.igen.com .

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