Important note: Information in this article was accurate in 1991. The state of the art may have changed since the publication date.
The Associated Press; Thursday, November 21, 1991
The easy-to-use and inexpensive test, developed and patented at the University of Florida, will be manufactured by the newly formed Oracle Diagnostics in Foster City, Calif., David Fowler, president of FutureTech, said Wednesday.
FutureTech is the Gainesville company licensed by the university to market the test.
The diagnostic method was invented by Dr. Roger Clemmons, a University of Florida researcher. Working with FutureTech, a research team has successfully completed a 3 1/2-year joint development effort and clinical evaluation.
Oracle Diagnostics plans to license worldwide distribution outside the United States and Europe to Nissho Iwai America Corp., a Japanese company with representatives in many countries.
"We think we'll become an important part, along with safe sex, in curbing this disease," Fowler said.
The tests will be marketed under the trademark OraScreen-HIV.
Dr. Jerome A. Mattingly, has been named president and chief executive officer of Oracle.
"Recognizing the need for simple, inexpensive HIV testing in developing countries, we have undertaken special efforts to make our OraScreen-HIV test available to the third world while we pursue FDA approval in the U.S," Mattingly said.
Formal approval of the OraScreen tests will be sought from the U.S. Food and Drug Administration next year, Mattingly said.
Researchers at the university said their tests show the product is about 100 percent reliable.
Fowler said the marketing of the test is a milestone in AIDS diagnostic research and development. Tests using blood samples require a long wait to detect exposure to the human immunodeficiency virus, which causes AIDS.
The AIDS test, which would cost about $5 and give a positive or negative reading in about 10 minutes, could be used at blood banks to test potential donors, at immigration posts, in dentist offices and emergency rooms and by people considering having sex, Fowler said.
One version of the test, an over-the-counter product, is likely to draw opposition from the FDA and other medical organizations, which prefer patients be tested at a doctor's office.
But the test is likely to gain widespread use in Europe and developing countries, where people view AIDS more as a disease that as a social problem, Fowler said.
With the number of AIDS cases increasing, Fowler said the demand for home testing will grow.
"I think you will see an outcry out there," he said.
Another version is for doctors, other health care professionals and government agencies.
The tests, which work something like a home pregnancy test, change color to indicate a positive test.
The version for professionals should be ready by next spring. The over-the-counter version will be ready next fall, Fowler said.
Copyright 1991/The Associated Press. Reproduced with permission. Reproduction of this article (other than one copy for personal reference) must be cleared through the Permissions Desk, The Associated Press, 50 Rockefeller Plaza, New York, NY 10020.
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Copyright © 1991 - Associated Press. Reproduction of this article (other than one copy for personal reference) must be cleared through the AP Permissions Desk.
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