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IGEN ORIGEN Technology to be Used in New Boehringer Mannheim Clinical Instruments; The Industry's First Universal Diagnostic Tool.

GAITHERSBURG, Md.--(BUSINESS WIRE)--July 20, 1995--ORIGEN technology, developed by IGEN, Inc., (NASDAQ:IGEN) as an extremely sophisticated and sensitive means for conducting immunoassays and nucleic acid probe detections, will be at the heart of a new family of random-access immunoassay systems for the reference laboratory from Boehringer Mannheim GmbH of Mannheim, Germany.

The two new systems were first shown last fall and MEDICA in Dusseldorf. System One will hold 18 reagent packets to assay the presence of, for example, hormones, cancer markers and infectious diseases, and is designed for high-throughput labs. This system will be manufactured by Hitachi as part of an on-going cooperative program in clinical chemistry instrumentation development between the two companies.

The second system, manufactured by Boehringer Mannheim, will have five reagents packets for labs with lower sampling requirements. The reagent packets are interchangeable.

System One is expected to be available in early 1996 in Europe and, pending FDA approval, in the U.S.

According to Dr. Richard Massey, President and Chief Operating Officer of IGEN, "The introduction represents the culmination of four years of work with Boehringer Mannheim. We view it as a model of a successful working relationship between a small, high technology company and a large, transnational enterprise with its marketing and manufacturing capability."

Background on ORIGEN

At the heart of the Boehringer Mannheim system is ORIGEN technology, an immunoassay system designed to perform multiple assays in a random-access mode, while handling stat tests, where results are needed immediately, without interfering with normal workflow.

The proprietary technology is applicable in life science research, animal care and industrial markets, as well as in clinical diagnostic markets ranging from hospital reference labs to patient point-of-care systems, to home use.

According to IGEN, ORIGEN is the world's first universal diagnostic tool, permitting virtually all clinical chemistry tests (measuring simple compounds like glucose and cholesterol), immunodiagnostic tests (detecting hormones, viruses and cancer markers), and nucleic acid tests (detecting specific sequences of DNA or RNA). For the first time, such tests can be performed on the same instrument using the same detection method. ORIGEN technology can also serve in the future as the basis for portable, hand-held Tricorder(TM) devices that can wirelessly transmit findings from remote locations.

Background on electrochemiluminescence

ORIGEN technology is based on the principle of electrochemiluminescence which utilizes labels that, when attached to a biological substance and then electrochemically stimulated, emit light at a particular wavelength. The light emission can then be measured with a high degree of accuracy to detect and quantify a variety of substances (analytes) such as hormones, bacteria, viruses and cancer. ORIGEN thus provides uniform assay formats to conduct a multitude of diagnostic tests including immunoassay, nucleic acid probe and clinical chemistry tests. ORIGEN is the only technology broadly protected by numerous patents in the United States and internationally, while other detection technologies now in use, such as chemiluminescence, fluorescence and radioisotopes, generally are not.

ORIGEN offers improved speed, sensitivity, flexibility and throughput relative to existing diagnostic technologies as well as lowering the cost of diagnostic procedures. The system does not involve the use of enzymes common in competing systems, thus permitting a simplified assay format. In addition, the system can be automated to provide in a uniform format a large number of immunoassay, nucleic acid probe and clinical chemistry tests.

To perform an assay, the clinical sample is measured into a test tube along with the necessary ORIGEN reagents and magnetic particles. The proprietary ORIGEN immunoassays typically consist of a capture antibody and a second ORIGEN-labeled antibody. When mixed with the clinical sample, both antibodies bind to the analyte and the capture antibody also binds to a magnetic particle, creating an ORIGEN-active complex. The mixture is then pumped into the flow cell, where a magnetic field is used to draw the ORIGEN-active complexes to the electrode, and low voltage is applied to the electrode to stimulate light output. This light output corresponds to the amount of ORIGEN-active complex present, and thus to the amount of analyte in the original sample, determining both the type and quantity of analyte. Washing steps are eliminated. The process is both simpler and more effective than any existing technology.

Other Firms Using ORIGEN Technology

U.S.-headquartered Perkin Elmer Corp. has linked its PCR technology to ORIGEN technology to produce the QPCR(R) System 5000 for the life sciences and research markets. Organon Teknika of the Netherlands has linked its NASBA technology to the ORIGEN analyzer to detect nucleic acids. Eisai Co., Ltd. of Japan, like Boehringer Mannheim, is developing diagnostic systems for use in clinical labs.

IGEN has been selling ORIGEN to the life science research market since 1993.

IGEN, Inc., (NASDAQ:IGEN) develops, manufactures and markets diagnostic systems utilizing its patented ORIGEN(R) technology, which is based on electrochemiluminescence. The ORIGEN technology provides a proprietary uniform assay format for conducting a multitude of diagnostic tests including immunoassay, nucleic acid probes and clinical chemistry tests. Products using the ORIGEN technology were first introduced in 1993 and include systems marketed by IGEN and its corporate partners, Organon Teknika, and The Perkin Elmer Corporation. -0-

Note to Editors: IGEN, ORIGEN and Tricorder are trademarks of IGEN, Inc.

CONTACT: IGEN, Inc.

George Migausky, 301/984-8000

or

Thomas Mahon Associates

Tom Mahon, 510/937-4921
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Publication:Business Wire
Date:Jul 20, 1995
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