Calypte Biomedical

Calypte Biomedical Corporation develops in vitro testing products to improve the diagnosis of human immunodeficiency virus (HIV) infection, sexually transmitted diseases, and other chronic conditions. The Aware™ HIV-1/2 OMT is one such product. Our innovative product line includes point-of-care rapid tests as well as traditional EIA diagnostic assays.Founded in 1988, Calypte was a pioneer in non-blood-based HIV antibody testing. We were the first—and remain the only—company to receive U.S. Food and Drug Administration (FDA) approval for a urine-based HIV-1 antibody screening test and supplemental Western blot. Today, our Aware™ line of rapid oral fluid HIV tests delivers unparalleled flexibility for ½ HIV testing in non-laboratory settings.Calypte is also the licensed manufacturer of a quantitative enzyme immunoassay developed by the U.S. Centers for Disease Control and Prevention (CDC) that distinguishes recent from long-term HIV-1 infections. Designed for epidemiological use, the Aware™ BED™ EIA is a practical method for determining HIV-1 incidence (the rate of new infections). Because the BED EIA uses cross-sectional rather than longitudinal sampling and is based on direct biomarker assessment, it provides incidence information faster than traditional methods like cohort studies. Since its introduction in 2004, the Aware™ BED™ EIA (formerly known as the BED HIV-1 Incidence EIA) has been widely adopted by government agencies and HIV intervention programs worldwide as a tool to better allocate resources, measure program success, and target HIV hotspots.