Important note: Information in this article was accurate in 1994. The state of the art may have changed since the publication date.
The Associated Press, Sat, 24 Dec 94
The test, called OraSure, is made by the biotechnology company Epitope Inc., in Beaverton, Ore., and will cost about $2 to $4, a fraction of the price of blood tests.
Although the test isn't as accurate as blood tests, Epitope expressed the hope Friday it will help more people learn whether they have HIV, the virus that causes AIDS.
"Whether they test positive or negative, they can take appropriate steps to protect themselves and others and, if they test positive, obtain early treatment for the disease," said Adolph Ferro, Epitope president and chief executive officer.
The FDA said the new test will be available only from physicians and will be administered only by people trained in its use. Epitope eventually hopes to offer it for sale directly to consumers.
Epitope has been seeking FDA approval of its saliva test for 3-1/2 long and lean years. The firm's profits took a beating as it awaited the federal action. In 1993, Epitope had an annual loss of $14.7 million, and earlier this month it announced a fiscal 1994 loss of $15.6 million.
After the FDA announcement, Epitope stock climbed $3.87 1/2 to close at $24.87 1/2 at on the American Stock Exchange.
Dr. Jeff Lawrence, a consultant to the American Foundation for AIDS Research, said the test could encourage people who would avoid blood tests to be tested.
"As long as a positive test is followed up with a blood test and as long as there is appropriate counseling available, it is a reasonable thing to do," said Lawrence.
The FDA approval actually involves two systems: a way to collect and preserve the oral fluid, and a way to test the specimen in a laboratory for the HIV virus.
The kit used to test the specimen in the laboratory is made by Organon Teknika Corp. of Durham, N.C., and is sold under the brand name "Oral Fluid Vironostika HIV-1 Microelisa System."
The test measures the presence in the saliva of the antibodies to the HIV virus. The virus itself has not been found in saliva.
To collect fluid for a test, a specially-treated cotton pad on a stick is placed between the lower gum and the cheek and allowed to absorb fluid. The stick then is placed into a plastic container with a preservative solution.
At a laboratory, the specimen undergoes an "enzyme-linked immunosorbent assay," or ELISA, test that is able to detect antibodies to HIV.
Positive tests are confirmed with a blood test called the Western Blot, which is more sensitive than the ELISA.
The FDA said the test has a 2 percent error rate. For instance, for every 100 people infected with HIV, the saliva test will miss one or two. For every 100 people who are not infected, test results will be incorrectly positive for approximately two people, the agency said.
"That is much, much poorer than with a standard blood test," Lawrence said.
Under the guidelines for approval, the saliva test is strictly forbidden for home use and cannot be used to screen blood donors.
Epitope said an estimated 60 million HIV screening tests are administered in the United States each year, about half at blood banks.
Copyright (c) 1994 - The Associated Press. Reproduced by permission. Reproduction of this article (other than one copy for personal reference) must be cleared through the Permission Desk, The Associated Press, 50 Rockefeller Plaza, New York, NY 10020.
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Copyright © 1994 - 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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