Calypte Biomedical’s subsidiary, Beijing Marr Bio-Pharmaceutical has received registration and marketing approval for Calypte’s Aware HIV-1/2 OMT (oral fluid) rapid test from the State Food and Drug Administration (SFDA) of China.

The Aware HIV-1/2 OMT product is a rapid test using oral fluid to diagnose HIV-1 or HIV-2 infection in as little as 20 minutes with accuracy comparable to that of US FDA approved blood based laboratory HIV EIA tests. According to Calypte, this is the first SFDA approved rapid oral fluid HIV test in China. Dr Ronald Mink, Chief Science Officer for Calypte said the transformation of the SFDA over the past two to three years into a first tier agency matching the rigor and integrity of its US and European counterparts resulted in a very thorough review of the Aware HIV test.