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Executive Summary

W-L's EARLY DETECTOR AT-HOME DIAGNOSTIC TEST FOR FECAL BLOOD will be marketed nationwide beginning in January. Availability on drug store and pharmacy shelves is slated for March 1985. The test will carry a suggested retail price of $4.99 to $5.99. FDA granted marketing clearance for the OTC product in August through the 510(k) abbreviated approval process. The agency determined the product is "substantially equivalent" to other tests already on the market. Warner-Lambert (W-L) is the third company to enter the OTC fecal blood test market. MenJames began selling SmithKline Beckman's Hemoccult test in September and C. B. Fleet introduced its DetecaTest in 1983. Like the other tests, Early Detector is intended to provide early warning for a number of disorders, including ulcers, hemorrhoids, diverticulitis, polyps and cancer of the colon or rectum. The firm is positioning the product as easier to use than the other tests. In a press release announcing the launch, Warner-Lambert quoted University of Washington Asst. Professor William Friend, MD, who declared: "Early Detector represents a breakthrough in this category. Unlike other tests available, it uses no sticks so there's no mess. As easy to use as toilet tissue, Early Detector is the simplest, most convenient test available today." The test uses "specially prepared paper tissue for collecting the stool sample," W-L said, explaining that one part of the tissue is treated with hematin. Test users are instructed to spray "Early Detector Developer Solution" onto the tissue after having obtained a stool sample."If within one minute any part of the specimen sample on the paper turns blue, the test indicates that hidden blood is present," the company explained. "No color change indicates that there is no hidden blood." Warner-Lambert is organizing a public service educational program to coincide with the market introduction of Early Detector. As part of the public service campaign the company will provide information on reducing the risks of colorectal cancer via booklets, and will sponsor a toll-free 800 number for additional information. Advertising of the product will appear in lay magazines and on television beginning in March, Warner-Lambert said. A separate ad campaign, aimed at the health care professional, includes print advertising in medical journals and distribution of information at medical conventions. W-L already is setting up booths at appropriate medical specialty meetings, a spokeswoman said. Direct mailing to physicians of the information booklet will begin this month, she added. W-L said its backing of the educational program will set an "unprecedented level of support" for the in-home diagnostics arena. The company estimates that growth in the in-home diagnostics market will be at a rate of 27% each year over the next six years. Currently a $200 mil. market, the area is expected to swell to $1 bil. by the 1990s, W-L predicted.

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