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This article was originally published in The Gray Sheet

Executive Summary

TRINITY BIOTECH SALIVA HIV-1 TEST CLINICALS are under way in Italy, India, Mexico and Abu Dhabi. The studies are evaluating a rapid enzyme immunoassay for HIV-1 antibodies that can be conducted with saliva samples. Initiated in March, the trials will involve approximately 1,200 patients divided into three groups: 500 patients known to be reactive to HIV-1 antibodies; 500 patients known not to be reactive; and 200 patients who have conditions such as tuberculosis or malaria that can interfere with blood-based results. The diagnostic test is designed to eliminate the need for "expensive laboratory equipment and the dependence on highly skilled technicians." The test specifically is intended for use "in settings where lab facilities are inadequate or unavailable," such as developing countries. To accommodate the use of saliva, which contains a smaller concentration of antibodies than does blood, the firm says it "optimized" reagents used in the sample- washing process. The Trinity device combines technologies developed by Irvine, California-based Disease Detection International and Amsterdam, Holland-based Saliva Technologies. DDI developed the "rapid test format," and Saliva Technologies developed the technology through which HIV antibodies can be detected in saliva. Trinity acquired rights to the technologies through a June 1992 pact with Saliva Research Ltd. (SRL), the parent of Saliva Technologies. SRL had obtained rights to the DDI SeroCard technology in an agreement signed earlier in 1992 ("The Gray Sheet July 20, p. 24). After trials on the saliva test are complete, Trinity will market the test through distributors in countries except the U.S. and Canada, where DDI has marketing rights, and Ireland, where the firm will do its own marketing. Pierrel SpA, an Italian subsidiary of Procordia/Kabi Pharmacia, is the firm's saliva test marketing partner for Europe. Trinity is expecting that DDI will file an investigational new drug application for U.S. clinicals this fall. Trinity also has marketing rights outside the U.S. and Canada for a SeroCard test that only uses blood samples and currently is selling the test through distributors in several countries. DDI is conducting a three-site clinical trial for the blood test in the U.S. ("The Gray Sheet" Nov. 2, p. 12). On April 6, Trinity announced that its marketing partner for Mexico and Central America is Panamerican Enterprises, with which it recently signed a five-year distribution agreement for both the saliva and blood tests. Trinity says that there already is a confirmed $4.5 mil. order under the pact from the Mexican government, which has ordered 2 mil. tests. The pact calls for delivery to begin in June and wind up within 10 months. Trinity will ship the blood-based tests until clinical trials for the saliva-based assay are complete, when the firm will substitute saliva-based assays for the blood-based tests.

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