LAKE OSWEGO, Ore., July 20 /PRNewswire-FirstCall/ -- Calypte Biomedical Corporation , medical diagnostic tests manufacturer for the professional point of care (PRO) and over the counter (OTC) segments of the market primarily for the detection of antibodies to the human immunodeficiency virus (HIV) announced today that its Aware(TM) BSP HIV-1/2 Rapid test is now approved for addition to the USAID waiver list, that is, the Acquisition & Assistance Policy Directive (AAPD 05-01) which permits this blood test to be used in USAID funded projects.
USAID provides assistance in four regions of the world: Sub-Saharan Africa; Asia and the Near East; Latin America and the Caribbean and Europe and Eurasia and has funded almost $6 billion since the inception of its HIV/AIDS program in 1986, more than any other public or private organization. USAID currently has HIV/AIDS programs in nearly 100 countries worldwide. USAID has delegated the task of evaluating HIV tests and deciding if data generated by that evaluation is sufficient to support that test being added to the waiver list to the Centers for Disease Control and Prevention (“CDC”). The CDC GAP Laboratory Support Team completed the interim validation of the Aware(TM) BSP HIV-1/2 Rapid test. The test met the requirements specific for USAID Waiver and CDC recommended it for inclusion in the waiver list. USAID has confirmed that the kit is so approved.
Roger I. Gale, Chairman and Chief Executive Officer of Calypte noted, “Only those assays meeting stringent performance criteria are placed on the USAID waiver list. This approval for the waiver list means that our product can now be used by USAID, the largest potential customer in the world. It is an additional validation of our rapid products as we expand our reach worldwide. As we continue to focus on humanitarian efforts, such as the announced roll out of MineSeeker’s African HIV/AIDS testing initiative, being on the USAID waiver list is expected to enhance our credibility and facilitate our involvement in further humanitarian programs.”
Mr. Gale continued, “At the same time, we have authorized an evaluation of our Aware(TM) OMT HIV-1/2 Rapid test for the USAID waiver list. Specimens are being collected over the summer and I estimate that the process can be completed towards the end of the year. The Aware(TM) OMT HIV-1/2 Rapid test is our single use, point-of-care aid in the clinical diagnosis of HIV infection that uses human oral fluid specimens to give results in less than 20 minutes. This test may also be used as a component of a multi-test rapid algorithm in conjunction with other approved HIV antibody assays.”
About USAID:
USAID (www.usaid.gov) is a United States government agency that receives overall foreign policy guidance from the Secretary of State. USAID provides assistance in four regions of the world: Sub-Saharan Africa; Asia and the Near East; Latin America and the Caribbean and Europe and Eurasia. USAID initiatives include global health and humanitarian assistance. USAID has funded almost $6 billion since the inception of its HIV/AIDS program in 1986, more than any other public or private organization. USAID currently has HIV/AIDS programs in nearly 100 countries worldwide.
About Calypte Biomedical:
Calypte Biomedical Corporation (www.calypte.com) 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 email:tgwin@calypte.com Investor Relations Contact: Tim Clemensen, Rubenstein Investor Relations Phone: (212) 843-9337 email:tclemensen@rubensteinir.com
Calypte Biomedical Corporation
CONTACT: Company Contact - Theodore R Gwin, Chief Financial Officer, +1-971-204-0282, tgwin@calypte.com; Investor Relations Contact - TimClemensen, Rubenstein Investor Relations, +1-212-843-9337,tclemensen@rubensteinir.com
