CALYPTE DISCUSSIONS WITH FDA ABOUT CONFIRMATORY HIV URINE TEST CONTINUE; AGENCY APPROVES FIRM'S URINE SAMPLE HIV-1 TEST AS PRELIMINARY SCREEN
This article was originally published in The Gray Sheet
Executive Summary
Calypte Biomedical is continuing talks with FDA concerning the data requirements for approval of a urine-based HIV-1 confirmatory test to complement the company's Calypte HIV-1 Urine EIA screening test. The screening test was approved by the agency on Aug. 6.