WASHINGTON, Dec. 23 -- The Food and Drug Administration announced Friday that it has approved the first saliva test for the virus that causes AIDS. The test, developed by Epitope Inc. of Beaverton, Ore., is the first approved in the United States that does not require blood samples. The test, to be marketed as OraSure, detects the hallmark of human immunodeficiency virus infection -- the presence of antibodies against HIV -- in the saliva. Because the test is simple and non-invasive, company spokesmen expect it to expand HIV testing. 'The medical community now has available to it a valuable new tool in the fight against AIDS,' said Adolph Ferro, president and chief executive officer of Epitope. 'We believe the availability of OraSure will allow more people to know their HIV status.' Because it is easy to administer and portable, the saliva test could become important in community outreach programs, life insurance testing, public health clinics, universities, and testing of individuals who are reluctant or unable to submit to blood tests. The test, however, is not available for home use and won't be used for testing the blood supply. 'Indeed, there are people who are very reluctant to have a needle stick in order to have an HIV test,' said John Fitchen, chief operating officer of Epitope. 'And, OraSure allows the collection to go to the patient rather than making the patient come to the clinic.' The test also has the advantage of protecting the personnel administering the test from the risk of needle stick accidents.
While the company spokesmen refer to the test as 'highly accurate,' FDA warns that the new HIV test system is not as accurate as the approved HIV-antibody tests used on blood. Studies show that for every 100 people infected with HIV, the oral-fluid-based test will miss one or two and for every 100 people who are not infected, test results will be incorrectly positive for approximately two people. The OraSure is an absorbent pad mounted on a lollipop-style plastic stick. The pad, which is treated with a salt solution to enhance collection of antibodies, is placed between the lower cheek and gum for two minutes. The sample is placed in a sealed vial that contains a preservative solution and sent to specially qualified laboratories for testing. The laboratory procedure -- known as an ELISA assay -- is similar to that for current HIV blood tests. However, a confirmatory test called a western blot has not yet been approved for the saliva test yet, so any positive results must be followed up with a confirmatory blood test. FDA has, however, imposed some restrictions on the testing system. Namely, the testing must be performed by people trained by a physician, can't be used for home use, and can't be used to screen blood. Epitope expects to start marketing the test within six weeks while labels are completed and laboratories go through the 'qualification' needed to accept and analyze samples. 'We hope to expand the uses of OraSure to testing for hepatitis B, and measles, mumps and rubella antibodies,' Ferro said. 'We see today as the launch of a new technology -- oral diagnostics.' FDA took four years to approve the new technology and the announcement sent Epitope stock soaring 3 to 24 on the American Exchange, where it was the second-most active stock. When the test is available it is expected to cost from $5 to $20.
