Calypte Announces Submission of Application to Chinese SFDA
For Approval of its Aware(TM) OMT Oral Fluid HIV-1/2 Rapid Diagnostic Test
LAKE OSWEGO, Ore., Jan 12, 2006 /PRNewswire-FirstCall via COMTEX News Network/ -- Calypte Biomedical Corporation (Amex: HIV) today announced that it has received notification from the Beijing Drug Administration (BDA) that its application for approval in China of its Aware(TM) OMT (Oral) HIV-1/2 rapid test has been formally accepted. The Company submitted its application to the BDA on December 27, 2005. According to Chinese drug registration regulations, the BDA is responsible for receiving applications on behalf of the State Food and Drug Administration of China (SFDA). Formal acceptance means that the BDA has completed an initial review of the application and deems the application to be sufficiently complete and in compliance with regulations to allow the application to advance into the formal review process.
Roger Gale, Chairman and Chief Executive Officer of Calypte said, "China is one of the countries that may experience a significant spread of HIV unless the government can follow through on its plans to curtail the growth of this problem. China has an acknowledged testing gap and has officially announced plans to offer voluntary HIV testing to its entire 1.36 billion-population, with particular emphasis on certain key groups, for which we believe our test is particularly appropriate. We believe that the only effective way to manage such testing thresholds is to utilize trained non-professionals to administer a program based on safe, non-blood or alternative fluid -- oral fluid -- testing."
Dr. Ron Mink, Chief Science Officer of Calypte added, "With the acceptance of our application by the BDA, Calypte has accomplished a key milestone in obtaining approval to sell our Aware(TM) HIV 1/2 OMT Rapid oral fluid product in the Chinese market. We believe that this product will have great appeal in China by virtue of its superior performance, competitive cost and advantages afforded by the use of oral fluid samples over other products available now or anticipated in the near future, in China."
China has a population of approximately 1.4 billion. According to a joint China, World Health Organization and UNAIDS epidemiological survey there were a reported 840,000 adults and children in China living with HIV/AIDS in 2003. Some experts have predicted that the number of infections by 2010 might exceed 15 million. The annual AIDS testing level is currently estimated at 1.5% of the population but is expected to grow -- partially due to a formal focus on mandatory testing in large markets such as population control, prisons and immigration and partially due to the Chinese government's program to offer voluntary HIV testing to its entire population.
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.