In Brief: Cambridge Biotech urine HIV test
This article was originally published in The Gray Sheet
Executive Summary
Cambridge Biotech urine HIV test: Cambridge Biotech's HIV-1 Western Blot confirmatory test for use with urine samples is approvable. A product license application supplement can be approved upon FDA sign-off on final labeling. The kit will be offered as the confirmatory test for the Calypte HIV-1 Urine EIA screening test, which FDA approved in August 1996 ("The Gray Sheet" Aug. 12, 1996, p. 3). Under an agreement between Calypte Biomedical and Cambridge Biotech, Calypte was responsible for collecting the data to support Cambridge Biotech's PLA supplement. In June 1996, FDA's Blood Products Advisory Committee concluded the test needed more data to demonstrate its effectiveness ("The Gray Sheet" July 1, 1996, p. 12)...