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This article was originally published in The Gray Sheet

Executive Summary

J&J CONDUCTING CLINICALS FOR MERIDIAN UTI TEST FOR OTC USE under the terms of a licensing pact between Johnson & Johnson's Advanced Care Products and Meridian Diagnostics. On April 7, Meridian announced that it has granted Advanced Care exclusive worldwide marketing rights to its FiltraCheck urinary tract infection test for the over-the-counter market. Currently, there are no UTI tests cleared for OTC marketing. Meridian sells FiltraCheck to hospitals, commercial labs and physicians' offices under 510(k) clearance from FDA. According to Meridian, "at least 60 million urinary screening tests are performed annually in the U.S. in hospitals, physicians' offices and nursing homes." After gathering clinical data, Advanced Care will submit a marketing application to FDA for the home-use indication. Meridian says that it is not clear whether FDA will require a 510(k) or a premarket approval application. Another recently cleared OTC test -- the ChemTrak/American Home Products CholesTrac cholesterol test -- was okayed for marketing under a 510(k) ("The Gray Sheet" March 8, p. 14). In Advanced Care, Meridian has an experienced marketing partner for the OTC diagnostics market. The J&J division sells the Advance and Fact Plus home pregnancy test lines. The licensing pact calls for Meridian to manufacture the OTC test and sell it directly to Advanced Care at a set price. The tests, which will be shipped in bulk by Meridian, will be packaged by Advanced Care. J&J has not yet determined whether it will market the tests in packages of one, two or three single-use tests, according to Meridian. FiltraCheck is a colorimetric test that screens urine for the presence of bacteria and white blood cells, which indicate the presence of pyuria. Four drops of urine are placed in a well in the center of the hand-held device. After 20 seconds, a reagent is added, and the test is read after an additional 30 seconds. If there is a color change, the test is positive; if there is no change, it is negative ("The Gray Sheet" July 22, 1991, p. 5). Meridian says that only packaging modifications are necessary to adapt the test for consumer use.

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