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Calypte Introduces Over-the-Counter Rapid Oral HIV Test

LAKE OSWEGO, Ore., Jan. 19 /PRNewswire-FirstCall/ -- Calypte Biomedical Corporation (Amex: HIV) today announced the introduction of an over-the- counter (OTC) version of the Aware(TM) Oral Fluid HIV-1/2 Rapid Diagnostic Test. Calypte expects to initially launch the sale of this product in over-the-counter markets in the United Arab Emirates, where the product has been registered, and then plans to distribute it throughout the entire Middle East as additional registrations and/or approvals are obtained.

The OTC Aware Oral Fluid HIV-1/2 Rapid Diagnostic Test will be distributed by Joseph and Gionis, Calypte's exclusive distributor for 22 Middle Eastern countries with a population of approximately 465 million people. According to the December 2004 UNAIDS report, there are between 230,000 and 1.5 million adults and children living with HIV within this region, of which nearly half are women.

Mr. Roger Gale, Chairman and Chief Executive Officer of Calypte stated, "We are extremely pleased to launch our newest product, an Aware Oral Fluid HIV-1/2 Rapid Diagnostic Test designed for use in an over-the-counter setting. We believe that this product will add another tool to increase detection and combat the spread of HIV virus and that the combination of an over-the-counter product with safe, oral fluid detection is well suited to reach the greatest number of individuals within the Middle Eastern countries. We look forward to a productive relationship with our newest distributor, Joseph and Gionis, as it continues to utilize its expertise in regulatory pharmaceutical and governmental affairs to facilitate the regulatory process in additional countries within its territory."

Mr. Gale, concluded, "Our launch of this over-the-counter product coincides with Arab Health, the largest Healthcare Exhibition in the Middle East, being held in Dubai, January 22-25th. We have already shipped the initial order to Joseph and Gionis in conjunction with this Exhibition and we believe we have sufficient inventory in stock to satisfy anticipated initial sales of this innovative product."

About Joseph and Gionis LLC

Joseph and Gionis is a global biotechnology consulting and distribution firm with offices in Newport Beach, California and the United Arab Emirates, specializing in new scientific developments which contribute to public health and welfare.

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.

    Company Contact:                  Investor Relations Contact:
    Theodore R Gwin,                  Tim Clemensen,
    Chief Financial Officer           Rubenstein Investor Relations
   (971) 204-0282                     Phone: (212) 843-9337
    email: tgwin@calypte.com          email: tclemensen@rubensteinir.com

SOURCE Calypte Biomedical Corporation