Business Wire - May 6, 2003

"This authorization opens up another market for our Cambridge Biotech Western Blot serum/plasma test," said Nancy Katz, Calypte's President and CEO. "When the FDA approached us about adding this indication to the serum Western Blot package insert last year, we were pleased that they considered the product could be used in this way. Now that the FDA has authorized us to promote our Western Blot as an accepted supplemental test for use with the newly approved HIV-1 rapid tests, we are taking immediate steps to revise our package insert and to inform healthcare providers so that we can enter this market as quickly as possible."

During the recent, April 24, 2003, Centers for Disease Control and Prevention (CDC) public broadcast on HIV Rapid Testing, FDA representatives stated that the Western Blot test was one of the preferred options for following up on reactive HIV-1 rapid test results. The Cambridge Biotech HIV-1 Western Blot has a long history of use as an HIV-1 supplemental test for use with serum and plasma specimens since it was approved by FDA in 1987. This product is currently manufactured in Calypte's Rockville, Maryland, facility and is widely used by blood banks, hospital and public health laboratories.

"We have been working with the FDA over the last few months to develop appropriate language to add into the package insert for our serum Western Blot test to address this need, and are very pleased that we have been given permission to implement these labeling changes," said Don Kafader, Calypte's Director of Regulatory Affairs. "When the FDA approved the first HIV-1 rapid test in the US, instructions concerning how to follow-up on reactive (or preliminary positive) test results were not clearly stated in rapid test product labeling. With the recent approval of a second HIV-1 rapid test, the need to address this situation became even more important."

About Calypte Biomedical:

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. When compared with existing blood-based tests, our testing algorithms are non-invasive, easier to use, less expensive and have significantly less risk than blood-based testing, and they have 99.7% sensitivity in subjects previously identified as HIV-1 infected and 100% specificity in subjects at low risk when combined with the urine-based Western Blot supplemental test. 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.

Statements in this press release that are not historical facts are forward-looking statements within the meaning of the Securities Act of 1933, as amended. Those statements include statements regarding the intent, belief or current expectations of the Company and its management. 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 and access funds from our existing financing arrangements 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, 2002 and its subsequent filings with the SEC.

CONTACT: Calypte Biomedical Corporation

Don Kafader, 510/749-5100, dkafader@calypte.com

or

Sitrick & Co.

Joe Bunning, 310/788-2850 (Investors), joe_bunning@sitrick.com

SOURCE: Calypte Biomedical Corporation

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