Calypte's Alameda Manufacturing Facility Approved by FDA: Alameda Facility Will Allow Increased Production of HIV-1 Antibody Urine Test.

Business Editors/Health & Medical Writers

ALAMEDA, Calif.--(BUSINESS WIRE)--Jan. 22, 2001

Calypte Biomedical Corporation (Nasdaq:CALY) announced today that it has been granted "pre-market approval" by the U.S. Food and Drug Administration (FDA) for the production, effective immediately, of the company's HIV-1 Urine EIA product in its manufacturing plant in Alameda, California. The facility, which is equipped with updated manufacturing technology and is larger than Calypte's current plant in Berkeley, will significantly increase the company's production and distribution capabilities.

The company decided to lease the Alameda facility when it became evident that increasing demand for its HIV-1 Urine EIA diagnostic product would soon surpass the production capabilities of Calypte's plant in Berkeley, California. By consolidating its West Coast manufacturing and distribution operations with its headquarters offices, Calypte expects to significantly reduce its overhead costs. Calypte is scheduled to begin manufacturing its HIV-1 urine product at the Alameda facility this month, and will close the Berkeley site in early 2001. The company's other manufacturing site, located in Rockville, Maryland, will remain in operation. The company originally received a FDA license to produce its HIV-1 Urine EIA diagnostic product in its Berkeley facility in August 1996.

"This is a highly significant milestone for Calypte," said Nancy Katz, President, CEO and CFO of Calypte Biomedical. "The Alameda facility will allow us to increase production, streamline the manufacture of our current products and provide the necessary space to develop new ones. We are proud that we were able to complete this process in under a year, which we believe demonstrates Calypte's commitment to the highest standards and full compliance with FDA quality systems and regulations," Katz said.

During the FDA's November 2000 inspection of the Alameda facility, the federal agency noted no "483 Inspectional Observations," a term describing significant adverse conditions relating to products and/or processes observed during an inspection. It is unusual for a manufacturing facility to pass a FDA inspection without at least a few minor issues requiring resolution.

Calypte Biomedical Corporation (Nasdaq:CALY), headquartered in Alameda, California, is a public healthcare company dedicated to the development and commercialization of urine-based diagnostic products and services for Human Immunodeficiency Virus Type 1 (HIV-1), sexually transmitted diseases and other chronic illnesses. Calypte's tests include the screening EIA and supplemental Western Blot tests, the only two FDA-licensed HIV-1 antibody tests that can be used on urine samples. The company believes that accurate, non-invasive urine-based testing methods for HIV and other chronic diseases may make important contributions to public health by helping to foster an environment in which testing may be done safely, economically, and painlessly. Calypte sells its products in over 40 countries worldwide through international distributors and strategic partners.

Statements in this press release that are not historical facts are forward-looking statements, including statements regarding insurance company adoption of the urine testing products and statements regarding marketing and distribution arrangements and plans. Such statements reflect management's current views, are based on certain assumptions and involve risks and uncertainties. Actual results, events, or performance may differ materially from the above forward-looking statements due to a number of important factors, and will be dependent upon a variety of factors, including, but not limited to, the Company's ability, directly or through third parties, to successfully manufacture and market the urine testing products and the ability of the Company to continue to finance its operations and to enter into distribution and marketing arrangements. The Company undertakes no obligation to publicly update these forward-looking statements to reflect events or circumstances that occur after the date hereof or to reflect any change in the company's expectations with regard to these forward-looking statements or the occurrence of unanticipated events. Factors which may impact the Company's success are more fully disclosed in the Company's most public filings with the U.S. Securities and Exchange Commission.