Calypte Announces Extended Expiration Dating for HIV-1 Western Blot Products

Business Wire, Nov 29, 2001

Business Editors and Health/Medical Writers

ALAMEDA, Calif.--(BW HealthWire)--Nov. 29, 2001

Calypte Biomedical Corporation (OTCBB:CALY) today announced that it secured FDA approval for extended dating of its Cambridge HIV-1 Western Blot products from 12 months to 15 months.

Obtaining extended dating was a critical milestone in the Company's manufacturing strategy. "This approval coupled with other measures aimed at reducing operational cycle time, plus the remarkable turnaround time from the FDA, will allow Calypte to provide product with longer dating and achieve greater operational efficiencies," said Barbara McAleer, General Manager.

"Extended expiration dating also supports our international strategy to offer products that help with the fight against HIV and AIDS worldwide," said Nancy Katz, President and CEO. "We know that the availability of extended dating has been a desire of many customers and that there are several international markets where our western blot products have not been made available. It is anticipated that this approval will make both the urine and serum western blot products a more attractive option in markets that are characterized by extended distribution channels or by the local lot release requirements of foreign-manufactured product."

In addition, extended dating can help new distributors acquire an appropriate working inventory before they have established a predictable demand for the products, since the likelihood of losses through expiration can be minimized.

Calypte Biomedical Corporation, headquartered in Alameda, Calif., 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.