Singapore, April 18, 2008: US healthcare company Calypte Biomedical said its Chinese 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.

 

Mr Roger Gale, Calypte's Chairman and CEO, said, China is committed to aggressively tackle the spread of its HIV epidemic and we believe that Aware HIV oral fluid test can and will make a significant contribution to that effort. 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.