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During the emerging AIDS epidemic in the early 1980s, Dr. Ruth Kirschstein, who worked for many years in biologics but was at this time was the Director of the National Institute of General Medical Sciences (NIGMS), helped to mobilize the National Institutes of Health (NIH) efforts to study the virus and develop and test drugs to combat this new public health threat in spite of political opposition.
Additionally, early biologics research on AIDS was carried out in Building 29A in the Division of Virology. The individuals involved in this early research include Drs. Lewellys F. Barker, Gerald V. Quinnan, Jr., Kathryn Zoon, and Jay Epstein
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On March 4, 1985, HHS Secretary Margaret Heckler announced that FDA had licensed the first test to detect exposure to the virus responsible for AIDS. The virus, known then in the U. S. as HTLV-III, had been identified and isolated in September 1984. The licensee, Abbott Laboratories, soon distributed the test to more than 2000 blood banks and plasma centers, as well as other laboratories serving clinics and physicians.
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FDA approved the first HIV test kit in March 1985 |
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Though not suitable for application in blood collection and processing facilities, CBER licensed the first clinical diagnostic test for direct detection of the HIV virus in 1989. Previous tests operated on the basis of indirect detection, based on an antibody response. The new test, HIVAG-1, detected HIV antigens in the patient’s serum or plasma, and it was expected to help physicians track the progress of their AIDS patients
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More Information:
- Progress Against AIDS Timeline
- NIAID History of AIDS Research Timeline
- FDA History page on AIDS
- Office of NIH History & Stetten Museum’s In Their Own Words exhibition.