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Biotech / Medical : T/FIF, a New Plateau -- Ignore unavailable to you. Want to Upgrade?

To: Icebrg who wrote (912)	2/5/2002 2:54:48 PM
From: Icebrg	Respond to of 2243

SPECTRAL DIAGNOSTICS INC. AND ELAN CORPORATION PLC ANNOUNCE SUCCESSFUL COMPLETION OF THE MEDIC MULTICENTER CLINICAL TRIAL DEMONSTRATING ABILITY OF THEIR DIAGNOSTIC TEST IN "RULING OUT" GRAM NEGATIVE INFECTIONS TORONTO/DUBLIN, March 19, 2001 - Spectral Diagnostics Inc. ("Spectral") (TSE: SDI) and Elan Corporation, plc ("Elan") (NYSE: ELN) today reported the successful completion of the MEDIC clinical trial carried out by Sepsis Inc. (a majority owned subsidiary of Spectral focused on the development of diagnostic tests for infection). Using an endotoxin activity assay newly developed by Sepsis Inc., the MEDIC trial demonstrated the ability of the test to rule out gram negative infection among critically ill patients with a greater than 90% negative predictive value. The endotoxin assay provides diagnostic information to the physician in one hour. Conventional methods for diagnosing infections rely on the use of cultures, the results of which are available to the physician within 24 to 72 hours. The MEDIC (Multi-Centre Endotoxin Detection in Critical Illness) trial studied 529 patients suspected of having an infection. The principal investigator was Dr. John Marshall, Professor of Surgery, University of Toronto, and Director of Critical Care Research at The Toronto General Hospital. The study investigators included 10 leading critical care physicians from intensive care units in the United States, United Kingdom, Belgium and Canada. Dr. John Marshall said, "Timely and reliable diagnosis is vital in managing infection in critically ill patients. Data from the MEDIC trial confirms that clinicians commonly administer broad-spectrum antibiotics for extended periods of time because they lack confidence in currently available diagnostic technologies. We know that the inappropriate use of antibiotics promotes the emergence of antibiotic resistant bacteria, and that this new approach to the diagnosis of infection may ultimately permit more controlled and directed use of these potent and expensive agents." Dr. Marshall will present the MEDIC trial data as an invited speaker at the prestigious 21st International Symposium on Intensive Care and Emergency Medicine in Brussels, Belgium, March 20-23, 2001. Dr. Marshall and his colleagues are expected to submit the MEDIC trial data and analysis for publication in a peer-reviewed medical journal in the near future. Dr. Paul Walker, President and CEO of Spectral, stated, "The results of this trial represent an important step forward in the ability rapidly to diagnose and treat infections in critically ill patients. Clinical management of these complex patients requires that diagnostic information be available in the shortest time possible. Now for the first time, information on the absence of gram negative infection will be available within one hour. While the suspicion of infection is high in critically ill patients, the incidence may be lower than expected. The ability to rule out gram negative infection promptly and confidently should facilitate more rational antibiotic use." Donal J. Geaney, Elan's Chairman and CEO, said, "We are delighted that these positive results support the accelerated development and regulatory submission of the endotoxin activity assay. A test that rapidly rules out gram negative infections represents a potentially important advancement in the management of patients in the ICU who are suspected of having infection." Elan has effective world-wide marketing rights to the gram negative endotoxin assay as well as future diagnostic products of Sepsis Inc. in the field of infection.