• RAPID DIAGNOSTIC TESTING
• INCIDENCE TESTING
• SAMPLING SYSTEMS

Advancing Practical Diagnostics

Calypte’s current product portfolio includes HIV diagnostic tests for the diagnosis and surveillance of the human immunodeficiency virus. We pioneered the development of non-blood-based HIV tests and were the first and only company to achieve approval from the U.S. Food and Drug Administration for a urine-based HIV-1 antibody screening test.

Calypte is concentrating today on our Aware™ HIV-1/2 OMT (oral fluid) HIV test that provides economical and accurate diagnostic results in about 20 minutes and our Aware™ BED™ EIA, the only practical HIV surveillance tool available for HIV-1 incidence testing.

With more than 8,600 subjects tested in formal clinical trials around the world, the non-invasive
Aware™ HIV-1/2 OMT (oral fluid) HIV test has a demonstrated accuracy of 99.8 percent—equal to the best rapid blood HIV tests. Its stability and long shelf life are particularly well suited for difficult testing environments that lack medical infrastructure.

Calypte has a strong relationship with the U.S. Centers for Disease Control and Prevention. The CDC selected Calypte as the contract manufacturer for the Aware™ BED™ EIA and has granted us worldwide marketing rights. Calypte continues to collaborate with the CDC to develop other new products including advanced assays for HIV and other infectious diseases.

With the USFDA and CDC now recognizing the need for an over-the-counter rapid HIV test, Calypte has acquired a research, development and manufacturing facility in Portland, Oregon, to create products for the U.S. market. Our initial product will be a new version of our successful Aware™ HIV-1/2 OMT test for the professional market followed by an over-the-counter version for consumers.