Calypte's Commitment to Compliance and Quality Yields Improved Operations, Cost Savings.

Business Editors/Medical Writers

ALAMEDA, Calif.--(BW HealthWire)--Oct. 9, 2001

Calypte Biomedical Corporation (OTCBB:CALY) today announced that recent compliance activities and approvals have enabled it to realize both improved operations and cost savings, as well as to better serve its customers.

"We view our company's commitment to regulatory compliance and the manufacture of the highest quality products for our customers as an unwavering goal," said Nancy Katz, President, CEO and CFO of Calypte. "It is who we are. We have faced many challenges over the last 18 months and throughout this time we have not lost sight of our regulatory obligations. I am proud to say that this remains a key operating philosophy for the company."

Katz noted that approval of the company's Alameda facilities earlier this year has enabled it to close its pilot plant in Berkeley. This action has resulted in operating savings of more than $500,000 annually, and improved the company's gross margins by 10%.

After facing residual regulatory compliance issues associated with the acquisition of its Rockville, Maryland manufacturing facility, an action plan was developed working with outside regulatory compliance experts.

Results from this effort have been tangible including the November 2000 FDA pre-approval GMP (Good Manufacturing Practices) inspection of the company's Alameda, California manufacturing facility, and the April 2001 FDA GMP re-inspection of the company's Rockville, Maryland facility which resulted in only minor comments.

"GMP compliance is only one area of Regulatory focus", says Ms. Katz. "Another significant area involves regulatory authority approvals of several submissions for product modifications, enhancements and manufacturing changes. Calypte has obtained a number of key regulatory approvals in recent months."

"Significant resources are required to maintain existing regulatory approvals and to obtain approvals for product changes on an ongoing basis," said the CEO. Some of the recent regulatory approvals obtained by Calypte include:

-- Approval of an extension of expiration dating for the urine controls in the
Cambridge Biotech HIV-1 Western Blot urine-testing product allowing for
enhanced manufacturing efficiency and improved customer utilization.

-- Approval of extended storage claims for urine specimens tested with the
Cambridge Biotech HIV-1 Western Blot urine-testing product to 18 months when
refrigerated and the addition of a storage claim of 55 days at room
temperature.

-- Approval for the manufacture of urine controls for Cambridge Biotech HIV-1
Western Blot urine testing product in the Alameda, California facility.

-- Approval to replace a panel member used in the manufacture of the Cambridge
Biotech HIV-1 Western Blot products in the Rockville, Maryland facility.

-- Approval of a change in regulatory classification for the Cambridge Biotech
HIV-1 Urine Western Blot product allowing for reduced manufacturing costs and
the distribution of a product designed for testing urine specimens only.

-- Approval that allowed Calypte to realize cost savings by performing some
product testing in-house that previously had to be sent to outside testing
services at a higher cost.

-- Approval for a change in the manufacture of the Cambridge Biotech HIV-1
Western Blot products resulting in increased production yields.

"By keeping the channels of communication open between our company and the regulatory authorities," Katz added, "we have been able to obtain several approvals allowing us to improve manufacturing operations, realize cost savings, and most importantly, improve our ability to meet customers needs."

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, as well as one of only two FDA-approved HIV-1 supplemental Western Blot tests available for testing serum samples.

Statements in this press release that are not historical facts are forward-looking statements, including statements regarding plans for future financing, the ability to meet financial and operational milestones, and shipments to domestic and 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 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, 2000 and its subsequent filings with the SEC.