Calypte Clinical Trial of HIV Tests

Calypte Biomedical Corporation have announced a progress report on the Chinese clinical trial program of its rapid HIV-1/2 tests in The Peoples Republic of China (China).

The ongoing trials are evaluating the sensitivity and specificity of the Company's three rapid HIV-1/2 Antibody Tests; Blood, Oral Fluid and Urine. The trials are also evaluating the Company's HIV-1 Western Blot supplemental tests in blood and urine. The Chinese clinical trial program is currently testing approximately 1,500 patients comprised of known HIV antibody positive subjects, high risk subjects, special situation subjects and low risk subjects.

The results of this program will form the basis to file the required regulatory applications with the Chinese FDA (SFDA). Dr. Richard George, President and CEO of Calypte said, "Based on our understanding of the current Chinese regulatory submission process, we expect to receive a response from SFDA around mid-2005, which would not alter Calypte's launch of its rapid HIV testing platform in China as originally projected during the second half of 2005. In parallel to the regulatory process, the Company has continued to advance its manufacturing strategy. Based on these efforts we expect to have production available to support the launch into China subsequent to regulatory approval."

There are a reported 840,000 adults and children in China living with HIV/AIDS today, and according to the Bill & Melinda Gates Foundation, China is one of the "next wave" countries where the number of infections is expected to grow to 15 million by 2010. China has recognized this problem and acknowledged its testing gap.

The annual AIDS testing level is currently estimated at 1.5% of the population. The Chinese government has recently announced its commitment to offer voluntary HIV testing to its entire 1.36 billion-population. Calypte believes that the only effective way to manage such numbers is to utilize trained non-professionals to administer a program based on safe, alternative fluid- oral fluid or urine - testing. There are other focused, and large markets within China where testing is mandated, such as population control, prisons and immigration.