FDA approves Calypte's HIV Western blot urine test:
This article was originally published in Clinica
Executive Summary
The US FDA has approved Calypte Medical's PMA application for the Cambridge Biotech HIV-1 Urine Western Blot. The product is intended to be used as a supplementary, more specific test for urine samples found to be positive for HIV-1 antibody using the company's EIA screening procedure. Among the benefits of the new regulatory status is the ability to extend the product's expiration dating, which should improve manufacturing efficiency and facilitate supply to international markets, says the Alameda, California firm.