Calypte Receives Exemption from FDA Lot Release Testing; Production-to-Market Time for HIV-1 Urine EIA Test Significantly Reduced.

Business Editors/Health & Medical Writers

ALAMEDA, Calif.--(BUSINESS WIRE)--Jan. 8, 2003

Calypte Biomedical Corporation (OTCBB:CALY), the developer and marketer of the only two FDA-approved HIV-1 antibody tests that can be used on urine samples, today announced receipt of U.S. Food and Drug Administration (FDA) approval to eliminate the lot release testing requirement for the company's HIV-1 Urine EIA test. This change is expected to reduce the production-to-market time by two to eight weeks and decrease associated production costs.

Nancy Katz, president and CEO of Calypte, stated, "The FDA has recognized Calypte's long-term manufacturing consistency, successful facility inspections and the extensive history of quality product performance. The Agency's determination to eliminate product sample submission prior to distribution indicates the FDA's confidence in our manufacturing and testing procedures, as well as our commitment to quality. We believe the elimination of lot release testing will improve our ability to efficiently manufacture products, to effectively satisfy growing product demand and to ensure greater manufacturing and supply predictability."

When the FDA approved the Calypte HIV-1 Urine EIA test in 1996 as a licensed biological product, it required submission of every lot for testing in FDA laboratories before the lot could be released for sale. Since then, Calypte moved its product manufacturing to its Alameda, California facility and secured the FDA pre-market approval (PMA) of the EIA product as a Class III medical device. Calypte submitted the lot exemption request to the FDA in November 2001, supplied additional data in August 2002, and received approval in late December 2002. The information presented to the FDA for its approval included data on 73 finished kit lots with over 400 individual component lots prepared.

In the FDA's approval letter, the Agency encouraged Calypte to seek the same elimination of lot release testing for Calypte's Cambridge Biotech HIV-1 Urine Western Blot, which is now also approved as a Class III medical device. Since this product's initial approval in 1998, it also has been required to undergo lot-by-lot release testing.

About Calypte

Calypte Biomedical Corporation, 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 infectious diseases. Calypte's tests include the screening EIA and supplemental Western Blot tests, the only two FDA-approved 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 infectious 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 markets its products in countries worldwide through international distributors and strategic partners. Current product labeling including specific product performance claims can be found at www.calypte.com.

Statements in this press release that are not historical facts are forward-looking statements, including statements regarding future revenues and sales projections, plans for future financing, the ability to meet operational milestones, marketing arrangements and plans, and shipments to and regulatory approvals in international markets. 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, our ability to obtain additional financing that will allow us to continue our current and future operations and whether demand for our product and testing service in domestic and international markets will continue to expand. 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 that may impact the Company's success are more fully disclosed in the Company's most recent public filings with the U.S. Securities and Exchange Commission ("SEC"), including its annual report on Form 10-K for the year ended December 31, 2001 and its subsequent filings with the SEC.