Calypte Announces Russian Federation Approval of Oral Fluid HIV Tests

LAKE OSWEGO, Ore., Sept. 21 /PRNewswire-FirstCall/ -- Calypte Biomedical Corporation (OTC Bulletin Board:CBMC), medical diagnostic tests manufacturer for the detection of antibodies to the human immunodeficiency virus (HIV) for the professional point of care (PRO) and over the counter (OTC) segments of the market announced today that it has received approval for its Aware(TM) Oral Fluid (OMT) HIV-1/2 rapid test for both PRO and OTC markets in the Russian Federation. The Russian Federation is now the second market, following the UAE, to approve the use of an HIV-1/2 test in OTC settings, permitting significantly greater access to HIV testing in these countries.

The approval has been entered into the State Register of Articles of Manufacturing for Medical Purposes and Medical Technology and is valid through August 10, 2011. The approval was granted by the Minister of the Federal Service of Health Care and Social Development Control of the Ministry of Health of the Russian Federation.

Mr. Roger Gale, Calypte's Chairman and Chief Executive Officer stated, "We have worked closely with Marr Technologies B.V. ("Marr"), our strategic partner and the Company's largest investor, whose introductions and coordination directly facilitated this approval. We look forward to continuing to work with Marr as we establish our distribution system in the Russian Federation. We plan to utilize their expertise in this region in support of our sales and marketing activities."

Mr. Gale continued, "Calypte is into the sales phase of its lifecycle, and given the potential size of the Russian market, we expect that it will be one of our most significant markets for sales. It is one of our highest priorities and we believe we can begin to supply the Russian market by year end. We believe strongly that the privacy and non-invasive ease of use provided by our OTC test are attributes that squarely address the needs of the Russian Federation in its plans to contain the HIV/AIDS epidemic."

Mr. Max Soulimov, Calypte Board of Directors member, commented, "I am pleased that Marr was able to help facilitate the approval of this important product for the Russian Federation. Marr has a long history within the country and is committed to improving the quality of life inside Russia. Calypte's test is a safe and effective non-invasive HIV-1/2 rapid test that can support both government HIV/AIDS awareness and treatment programs and provide a personal and private option to Russian citizens. In my opinion, the OTC oral fluid rapid test will be a strong tool in the fight against AIDS."

Mr. Marat Safin, President of The Marr Group stated, "We are pleased to have assisted Calypte in obtaining approval for its Aware(TM) HIV-1/2 Oral Fluid rapid tests. It is well documented that young people aged 15 to 29 are increasingly bearing the brunt of new HIV infections and the number of reported cases of pregnant women with HIV has continued to increase significantly over the past few years. Marr is committed to be affiliated with these efforts to ensure the availability of this non-invasive test as a key component in a comprehensive response to combating the combined challenges of HIV and injection drug use in the Russian Federation."

About the Russian Federation:

The Russian Federation is home to 143 million people. According to the 2005 AIDS Epidemic Update jointly published by the Joint United Nations Programme on HIV/AIDS (UNAIDS) and the World Health Organization (WHO), there are 860,000 adults living with AIDS in the Russian Federation (as of the end of 2003). The Update notes, "In early 2004, more than 80% of all officially reported HIV cases since the beginning of the epidemic had been among drug injectors. The epidemic, meanwhile, is becoming more mature. Most drug injectors are sexually active and, if HIV-infected, they can transmit the virus sexually to their casual or regular partners. About 6% of registered infections were related to sexual transmission in 2001; by 2004, that proportion had grown to 25%." The Bill and Melinda Gates Foundation consider Russia one of the "Next Wave" countries facing the largest increase in HIV/AIDS this decade. In 2004, Russia established a Country Coordinating Mechanism (CCM) to address the situation. The CCM membership includes the government, as well as NGOs, the people living with AIDS network, and UNAIDS donors. The UNAIDS/WHO Update observes, "Substantial international funding has been made available to scale up harm reduction programmes and drug treatment services." Calypte believes that its non-invasive OTC rapid test can have an immediate positive impact on the effort to increase diagnosis and treatment of HIV/AIDS in this region.

About Calypte Biomedical:

Calypte Biomedical Corporation ( is a U.S.-based healthcare company focused on the development and commercialization of diagnostic testing products for the detection of sexually transmitted diseases such as the HIV-1 BED Incidence EIA and 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 there is a significant need for rapid detection of such diseases globally to control their proliferation, particularly in developing 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 for the year ended December 31, 2005 and its subsequent filings with the SEC.

    Company Contact:
    Theodore R Gwin, Chief Financial Officer
    (971) 204-0282

    Investor Relations Contact:
    Tim Clemensen,
    Rubenstein Investor Relations
    Phone: (212) 843-9337

Source: Calypte Biomedical Corporation

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