Calypte Biomedical Corporation Expands Use Of HIV-1 BED Incidence EIA Test

LAKE OSWEGO, Ore., Dec. 21 /PRNewswire-FirstCall/ -- Calypte Biomedical Corporation today announced the addition of dried blood spot samples as a new indication for use with the Calypte HIV-1 BED Incidence EIA. The Calypte HIV-1 BED Incidence EIA Dried Blood Spot Control Pack is now available as an accessory quality control reagent to customers interested in testing dried blood spots for HIV-1 incidence. Initially, the Calypte HIV-1 BED Incidence EIA had only been evaluated for use with serum and plasma specimens. Dried blood spot samples can be obtained from blood serum, blood plasma or whole blood, and all three specimen types can be tested simultaneously with this new indication.

Unlike most HIV antibody tests that are designed as a screening test to determine if an individual has been exposed to HIV-1, the Calypte HIV-1 BED Incidence EIA is a population research tool intended to determine the number of persons in a known population that have been infected within a 6 month period. Such information may give policymakers and program managers valuable insights into the success of prevention programs and guidance on the optimal allocation of resources. Additionally, the test may be valuable for targeting populations with a high incidence of HIV infections for interventional studies and/or vaccine trials.

Mr. Roger Gale, Chairman and CEO of Calypte explains, “The addition of a dried blood spot indication will allow more flexibility with Calypte’s HIV-1 BED Incidence EIA, as dried blood spots are easier to collect, handle and transport than serum or plasma samples. The additional dried blood spot indication may allow the BED HIV-1 Incidence test to be used as a tool to facilitate collection of HIV-1 incidence data from difficult to reach populations in remote locations where traditional laboratory facilities and conveniences such as refrigeration are not available. Furthermore, this new indication should facilitate testing of archived dried specimens that could not have been previously tested.”

The product is available in inventory and first sales have shipped.

About Calypte Biomedical:

Calypte Biomedical Corporation is a US-based healthcare company focused on the development and commercialization of diagnostic testing products for the detection of sexually transmitted diseases. Calypte specializes in novel tests such as the HIV-1 BED Incidence EIA and is engaged in developing and commercializing new diagnostic test products for the rapid detection of HIV and other sexually transmitted diseases, several of which do not require blood samples. Calypte believes that there is a significant need for rapid detection of such diseases globally to control their proliferation, particularly in lesser-developed countries, which lack the medical infrastructure to support laboratory-based testing. Calypte believes that testing for HIV and other sexually transmitted infectious diseases may make important contributions to public health, and could increase the likelihood of treating those with undetected HIV and other sexually transmitted diseases.

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, the Company’s ability to obtain additional financing, if and as needed, and access funds from its existing financing arrangements that will allow it to continue its current and future operations and whether demand for its test products in domestic and international markets will generate sufficient revenues to achieve positive cash flow and profitability. 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-KSB/A (No. 2) for the year ended December 31, 2004 and its subsequent filings with the SEC.

Investor Relations Contact: Tim Clemensen 212-843-9337 tclemensen@rubensteinir.com

Calypte Biomedical Corporation

CONTACT: Tim Clemensen, +1-212-843-9337, tclemensen@rubensteinir.com, forCalypte Biomedical Corporation

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