Calypte Biomedical completes new Aware HIV-1/2 oral fluid rapid test internal studies

Calypte Biomedical Corporation (OTCBB:CBMC), a developer, manufacturer and marketer of HIV diagnostic tests, today announced successful completion of internal studies of its new Aware HIV-1/2 oral fluid rapid test for the US and international markets.

"I am pleased that Calypte's new Aware HIV-1/2 rapid test has been successful in these studies. We strongly believe that our product has the potential to significantly improve HIV testing and early diagnosis," said Adel Karas, Chairman and CEO of Calypte.

The trials were performed at two sites – one in South Africa and one in the US – and generated data from 577 subjects at various levels of risk for HIV infection. In combined results, Calypte's new Aware HIV-1/2 oral fluid rapid test showed an accuracy of 100%.

"We believe that we have a test that performs as well as any other HIV-1/2 oral fluid test in the market," said Richard George, former CEO of Calypte, who is currently a scientific advisor to the company.

Based on these promising results, Calypte has contacted the FDA and started the process to conduct clinical trials in the second half of 2011.