FutureTech Industries Inc, of Gainesville, Fla., hopes to market a home test for AIDS within the next year. Prototype plans and feasibility research are now under review for the product, which was developed at the University of Florida. The prototype is scheduled for clinical testing in August.
The test requires a urine sample, making the process possible for consumer use and safer for medical personnel than the present blood-based method. It is selfcontained, accurate, and inexpensive, according to David Fowler, president and CEO of the threeyear-old firm.
Ernest H. Moyer, vice president and chief operations officer of FutureTech, told Drug Topics that the targeted retail price for the test is between $10 and $20 "We hope we can market the test at this price so there will be no economic barrier for anyone."
FutureTech anticipates Food & Drug Administration approval of the test within six months of the prototype, since the method is noninvasive and uses existing chemistry for AIDS testing. The FDA said it is unlikely to approve home blood tests for AIDS but has taken no position on the recent urine-based development.
New York University is also seeking a patent for the "dipstick" AIDS test. Alvin FriedmanKien, professor of dermatology and microbiology at the N.Y.U. Medical Center, said the presence of the AIDS antibody in urine is difficult to explain but should allow for the development of a urine-based test. Since bloodborne viral antibodies don't usually appear in urine, researchers did not look for them in urine until recently, remarked Friedman-Kien.
An alliance with a large drug corporation for marketing and distribution of the test kit is being explored now by FutureTech. In addition, the firm will fund additional research by the University of Florida to develop test kits for other sexually transmitted diseases, which may be incorporated into the AIDS test. Research is done under an exclusive licensing agreement between the university's division of sponsored research and FutureTech.
N.Y.U. is also negotiating with certain unnamed firms to license the process.
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