Home » Drug Information » FDA-Approved Drugs » 1995
Medical Areas: Endocrinology | Immunology/Infectious Diseases
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Drug Information
The following information is obtained from various newswires, published
medical journal articles, and medical conference presentations.
Company: Epitope
Approval Status: Approved in December 1995
Treatment Area: HIV testing
In December, 1994, the FDA approved Epitope's saliva test
for HIV. However, Epitope's test system (which includes an oral
specimen collection device, as well as the HIV test itself) is not
as accurate as HIV-antibody tests from blood samples. Studies show
that for every 100 people infected with HIV, the oral-fluid-based
test will miss one or two. The test also gives false positives
about two percent of the time.
To confirm the HIV-positive saliva-test results, Epitope
developed a Western blot confirmatory device. The FDA approved this
confirmatory test in December of 1995.
