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NMS PHARMACEUTICALS ENTERING OTC DIAGNOSTIC MARKET WITH EZ-DETECT

Executive Summary

NMS PHARMACEUTICALS ENTERING OTC DIAGNOSTIC MARKET WITH EZ-DETECT fecal occult blood test following FDS's approval of the product June 24. Approved under a 510(k) application, which signifies the product is "substantially equivalent" to tests already on the market, EZ-Detect will be priced at $7 to $8 for a one-unit package that will contain three separate tests. The Newport Beach, California-based NMS said it is establishing distributorships in the U.S. as well as Europe and that negotiations are under way with "several large companies" to handle marketing of the kit. The test is performed by dropping a chemically treated biodegradable tissue paper into the toilet following a bowel movement. If the test is negative, there is no change in tissue color; the tissue turns blue if test results are positive. NMS claims a 100% accuracy rate for the test. Advantages of the EZ-Detect include ease of use and the test's ability to maintain its reading for four to five hours, the company said. According to NMS estlmates, the physician's office market for fecal occult blood tests is about 540 mil. The OTC market should be double that, the firm predicts. NMS said it expects first year sales for EZ-Detect to be $1 mil. to $1.5 mil. EZ-Detect is the fourth fecal occult blood test to enter the OTC market. C.B. Fleet introduced the first such test, DetecaTest, in August 1983, which was followed about a year later by SmithKline's Hemoccult II, introduced in September 1984. Warner-Lambert's Early Detector joined the field this past January. NMS has also submitted a 510(k) application to FDA for a laboratory and physician's office version of the test, ImmunOccult, NMS primarily manufactures and markets immunodiagnostic test kits for laboratories, hospitals and clinics.

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