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Executive Summary

WHITEHALL TO MARKET UNIPATH's CLEARBLUE EASY ONE-STEP HOME PREGNANCY TEST in the U.S. American Home Products' Whitehall division will support the second-generation OTC pregnancy kit with a national television and print campaign for consumers. A professional program also is planned. FDA cleared the product for marketing via a 510(k), the abbreviated application approval route for medical devices and in vitro diagnostics. Unipath, a subsidiary of Anglo/Dutch firm Unilever, introduced Clearblue Easy in the United Kingdom in June, Marketing Director John Bird told a Sept. 15 symposium sponsored by the Wilkerson Group in New York City. "We are now working to introduce that product in as many countries as possible in the next few months," he added. The test is designed to remove all need for user manipulation, Bird explained. To use the kit, the consumer holds a one-piece sampling device in the first morning urine stream, then replaces the cap and waits for three minutes. Results appear in two windows on the device. If a blue line appears in the first, larger window, it indicates pregnancy. A blue line will always appear in a second, smaller window to show that the test's integral control is working and that the test is successfully completed. Unipath's OTC diagnostics originally were sold in the U.S. by VLI Corporation, which was acquired by American Home in December 1987. VLI began selling Unipath's original Clearblue test in January 1987, followed by the Clearplan home ovulation test in September 1987. The new pregnancy test is being sold in Europe under the name Clearblue One Step. In the U.K., where Unipath holds about 50% of the home pregnancy testing market, the test is priced at about a 20% premium to competing products, Bird said. Whitehall said it is selling Clearblue Easy, which is available in packages of one or two tests, at a price "competitive" to existing products. Unipath was established in 1984 as the medical diagnostics subsidiary of Unilever. Located in Bedford, England, the company launched its first product, Clearblue, in 1985, and became the market leader within three months, Bird said. Unipath's OTC sales have grown from $ 1 mil. at the end of 1985 to $ 7 mil. by the end of 1987, Bird noted. While sales of Clearplan have been "disappointing," Bird said, growth in pregnancy product sales is expected to push 1988 OTC revenues to $ 11 mil.

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