Calypte History

Calypte Biomedical Corporation was founded in 1988. The Company is named for Calypte anna, an emerald- and ruby-colored hummingbird native to California.

The Company is best known for its development of reliable screening and supplemental urine tests for HIV-1 antibodies. The company's first product was a urine-based screening test for the detection of antibodies to HIV-1, the virus that causes Acquired Immunodeficiency Syndrome (AIDS). The Calypte HIV-1 Urine EIA [Human Immunodeficiency Virus Type 1 (Recombinant)] and the confirmatory test  the Cambridge Biotech HIV-1 Western Blot Kit [Human Immunodeficiency Virus Type 1 (HIV-1)] are FDA approved.  These products along with the Cambridge Serum HIV-1 Western Blot have been sold to Maxim Biomedical in Rockville, Maryland now operating at the site of the original manufacturing facility for the Cambridge Western Blot.

 In April 2004 Calypte announced that it had taken a license from the United States Centers for Disease Control and Prevention (US CDC) for the commercial production of a research epidemiology test intended to estimate HIV-1 incidence in populations. Unlike most HIV antibody tests, the Calypte HIV-1 BED Incidence test is designed to discriminate between those infections that have been recently acquired and those that were acquired in the more distant past. Measurements of the dynamics of HIV spread in populations are a useful way to measure the success of HIV intervention programs, and an important element of resource planning.  A unique feature of the Calypte HIV1 BED Incidence test is the ability to identify HIV infection in the viral subtypes that are found most often in the developing world.

The Company has also made the development of rapid tests for HIV-1 / HIV-2 antibodies a corporate priority. The company’s Aware™ line of rapid tests is specifically designed to meet the cost and performance needs of the developing world, and more importantly, to offer HIV testing agencies the choice of three sample types: blood, urine, and oral fluid. As of July 2005, two of the three assays (blood and oral fluid) have been commercially launched in the developing world. The Company has acquired licenses to the intellectual properties that give it freedom to market these tests in the markets that it has prioritized.

Calypte markets its products through a network of national and regional distributors.