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Calypte Biomedical Receives Final Report From China Clinical Trials
LAKE OSWEGO, Ore., Sept. 6 /PRNewswire-FirstCall/ -- Calypte Biomedical Corporation (Amex: HIV) today announced that it has received the final clinical trial report from the Chinese Centers for Disease Control (Chinese CDC) confirming the performance of the five Calypte HIV tests that were evaluated earlier this year. Three rapid HIV tests, Aware HIV-1/2 BSP, Aware HIV-1/2 OMT, and Aware HIV-1/2 U were evaluated in these studies. These tests employ, respectively, blood, oral fluid, and urine samples. In addition, the Calypte HIV-1 Serum Western blot and the HIV-1 Urine Western blot tests were evaluated for their performance in various Chinese provinces and populations. The clinical trial was performed by the Chinese CDC.
The clinical trial of the three rapid tests included 1506 subjects; 247 of whom were infected and 1259 of whom were uninfected. The table below summarizes the performance of the rapid tests.
Sensitivity Specificity Accuracy
Aware HIV-1/2 OMT 100.0% 99.8% 99.9%
Aware HIV-1/2 U 97.2% 100.0% 99.5%
Aware HIV 1/2 BSP 100.0% 99.3% 99.4%
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.
The serum and the urine HIV-1 Western blots also performed well, with sensitivities of 100% and 98.4%, respectively. The specificity of the urine Western blot was 100% and the specificity of the serum Western blot was 99.4%. The specificity of the serum Western blot was less than 100% as a result of two HIV-negative subjects whose sera displayed bands for p24, resulting in a so-called "indeterminate" interpretation. The presence of p24 antibodies is a common occurrence in uninfected individuals, and indeterminate results should not be confused with false positive results.
Dr. Richard George, President and CEO of Calypte said, "We are extremely encouraged by the excellent outcome of the China clinical trial. The Chinese CDC did an admirable job of conducting these studies and preparing the report. We now believe that all three rapid assays are approvable and that the OMT and urine tests are eligible for accelerated review. As I stated in our most recent conference call on August 15, the first application we file will be for approval of the Aware HIV-1/2 OMT test. We expect to make the submission in the coming weeks. The OMT application will be followed shortly by a submission for the Aware HIV-1/2 Urine test."
Dr. George continued; "Work in China continues at a vigorous pace to prepare for the impending launch of our sales effort after receipt of SFDA approval. Dr. Ron Mink, Calypte's Chief Science Officer, and members of his scientific staff are currently at our manufacturing facility near Beijing training our staff to make the rapid assays. We are also expecting delivery and installation of automated manufacturing equipment in early September. It is very gratifying to see all of our hard work resulting in a successful conclusion."
About China:
China has a population of approximately 1.4 billion. According to a joint China, World Health Organization and UNAIDS epidemiological survey there were 840,000 adults and children in China living with HIV/AIDS in 2003. In July of 2004, the Chinese premier, Wen Jiaboa went so far as to acknowledge HIV/AIDS as one of the "serious problems" facing China. Some experts have predicted that the number of infections by that date might exceed 15 million. Most experts agree that testing and education are the most important things that can be done to stem the spread of HIV/AIDS. To that end, the Chinese government has recently announced its commitment to offer voluntary HIV testing to its entire 1.36 billion-population. In countries where HIV infection has been contained, according to UNAIDS estimates, annual testing rates of the population aged 15-64 that is tested in a non-blood bank setting is between 15% and 25%. To effectively combat the spread of infection and meet the goals they have set for themselves, we believe that China must bring testing rates up to these levels and that this can only be done by the use of simple, inexpensive, and safe tests that can be performed on non-blood samples such as oral fluid and urine. Such tests can be performed in large numbers by non-medical personnel in all types of non-traditional settings.
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: www.calypte.com
Tim Clemenson-212-843-9337
tclemenson@rubensteinpr.com
SOURCE Calypte Biomedical Corporation
09/06/2005
CONTACT: Tim Clemenson, +1-212-843-9337, or tclemenson@rubensteinpr.com/ /Web site: http://www.calypte.com
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