J&J CONDUCTING CLINICALS FOR MERIDIAN's UTI TEST FOR OTC USE
This article was originally published in The Tan Sheet
Executive Summary
J&J CONDUCTING CLINICALS FOR MERIDIAN's 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 said it has granted Advanced Care worldwide, exclusive 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 physician offices under 510(k) premarket clearance from FDA. According to Meridian, "at least 60 mil. 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 OTC indication. Meridian says that it is not clear whether FDA will require a 510(k) or premarket approval application for OTC use. Another recently cleared OTC test -- the ChemTrak/Whitehall CholesTrac cholesterol test -- was okayed for marketing under a 510(k) ("The Tan Sheet" March 8, p. 9). 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 test, which will be shipped in bulk by Meridian, will be packaged by Advanced Care. J&J has not yet determined whether it will market FiltraCheck 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. Meridian said that only packaging modifications are necessary to adapt the test for consumer use.