Calypte's Aware(TM) HIV-1/2 BSP Test Receives Zimbabwe Approval
Regulatory Trials Of Aware(TM) BSP Generate 100% Accuracy
LAKE OSWEGO, Ore., Sept. 15 /PRNewswire-FirstCall/ -- Calypte Biomedical Corporation (Amex: HIV) today announced that the Medical Laboratory & Clinical Scientists Council of Zimbabwe has issued notification that the Calypte Aware(TM) HIV-1/2 BSP rapid (blood) test has been successfully evaluated and cleared for commercial sale in Zimbabwe.
The Calypte Aware HIV-1/2 BSP rapid test was evaluated under the direction of the Medical Laboratory & Clinical Scientists Council of Zimbabwe on over 1,000 samples. Roughly half of the samples were archived samples from the national reference panel and the other half were collected prospectively from clinical patients, blood donors, and attendees at VCT (Voluntary testing and Counseling) sites. The clinical trial of the Aware HIV-1/2 BSP rapid test included 1,005 subjects; 224 of whom were infected and 781 of whom were uninfected. The table below summarizes the performance of the rapid tests.
Sensitivity Specificity Accuracy
Aware HIV-1/2 BSP
Archived Samples (500) 100.0% 100.0% 100.0%
Prospective Samples (505) 100.0% 100.0% 100.0%
Sensitivity is a measure of the number of infected subjects correctly identified as positive. Specificity is a measure of the number of uninfected subjects correctly identified as negative. Accuracy is a composite measure of how many of the test subjects were correctly classified as infected or uninfected.
Calypte and its distributor, National Diagnostics, are now working with authorities on a process by which Aware HIV-1/2 OMT (oral fluid) and HIV-1/2 U (urine) rapid assays can be evaluated. Zimbabwe has not had the opportunity to field test non-blood HIV screening tests before, and its standard approach to evaluate HIV antibody tests is not appropriate for samples such as urine and oral fluid. The authorities are examining various proposals for such an evaluation.
Dr. Richard George, President and CEO of Calypte said, "We are delighted that the BSP test has passed yet another regulatory hurdle, and we now look forward to working with National Diagnostics, our distributor in Zimbabwe, to get the product commercially launched. In parallel we hope to complete the evaluation using the Company's technology in Urine and Oral fluid."
Tony Mariani, President of National Diagnostics, added, "We are extremely pleased with the exceptional results achieved by the Aware BSP HIV-1/2 kit in its evaluation phases. We look forward to our venture with Calypte in the marketing and distribution of this kit throughout Zimbabwe. Since our establishment in 1991, National Diagnostics has imported and distributed a wide range of diagnostic reagents, and this project promises to be one of the most important undertakings in our company's history".
Zimbabwe, with a population of just under 13 million, has an estimated 1.8 million HIV infections, according to the UNAIDS 2004 Report on the Global AIDS Epidemic, ranking as the 3rd largest prevalence in Africa today.
Aware(TM) BSP is a twenty-minute rapid test designed to detect HIV antibodies in whole blood, serum, or plasma. It is one test in a line of three such assays, the other two being designed to detect HIV antibodies in oral fluid and urine.
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
SOURCE Calypte Biomedical Corporation
-0- 09/15/2005
/CONTACT: Investor Relations, Tim Clemensen, +1-212-843-9337,
tclemensen@rubensteinir.com, for Calypte Biomedical/
/Web site: http://www.calypte.com/
(HIV)
CO: Calypte Biomedical Corporation
ST: Oregon, Zimbabwe
IN: HEA MTC BIO
SU: BLK
AS
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2935 09/15/2005 08:41 EDT http://www.prnewswire.com
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