Federation Approval of Oral Fluid HIV Tests
Thursday September 21, 8:00 am ET
LAKE OSWEGO, Ore., Sept. 21 /PRNewswire-FirstCall/ -- Calypte Biomedical Corporation (OTC Bulletin Board: CBMC - News), 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.
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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
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