Calypte Biomedical
This article was originally published in The Gray Sheet
Executive Summary
Urine-based HIV-1 screening test manufacturer and FDA will discuss accelerating development of a new rapid HIV urine test during a pre-IDE meeting scheduled for early October. Preliminary data indicate 100% sensitivity and specificity, the firm claims. Calypte has an agreement with SA Scientific to develop and manufacture the test at its San Antonio facilities, while Calypte will manage the clinical trials (1"The Gray Sheet" Dec. 3, 2001, In Brief)...