Calypte Biomedical Corporation (OTCBB: CBMC), a developer, manufacturer and marketer of HIV diagnostic tests, announced today that the Chinese State Food and Drug Administration (“SFDA”) has notified Calypte’s Chinese manufacturing subsidiary, Beijing Marr Bio-pharmaceutical Co., Ltd., (“Beijing Marr”) that the technical review of its Aware™ HIV-1/2 OMT rapid oral test product application has been completed. Pending the SFDA’s review of conformity to product standard documents and labeling to applicable regulations, the application will progress to the concluding administrative approval.
Roger I. Gale, Calypte's President and Chief Executive Officer, stated, "This is a major milestone in a long and difficult approval process. We are extremely pleased that the SFDA has determined that our scientific data has met their criteria, and that we are now moving into the final phase of the registration process. We believe that in meeting the technical standards established by the SFDA, we have demonstrated to them the high quality of our product.”
Dr. Ronald W. Mink, Calypte’s Chief Science Officer, commented, “The technical review is considered the most challenging and lengthy portion of the SFDA review process, and is the penultimate milestone in the approval process. We are absolutely delighted that we have overcome what is arguably the highest hurdle in the approval process, and are ready to move into the final administrative stage.”
David K. Harris, Beijing Marr’s Chief Executive Officer stated that, “The notice from the SFDA is of paramount importance and indicates that the substantive content of the application and the technology itself have met with the acceptance of the SFDA and are acceptable for the Chinese market. Nearing the end of an arduous approval process, we are very proud to see this recognition of years of hard work in developing the AwareTM HIV-1/2 OMT product.”
Calypte operates in China through Beijing Marr, a joint venture between Calypte and the Marr Group established to manufacture Calypte’s Aware™ line of rapid HIV tests, including the Aware™ HIV-1/2 OMT product for both the Chinese and international markets. The Aware™ HIV-1/2 OMT product is a rapid test using oral fluid to diagnose HIV-1 or HIV-2 infection in as little as 20 minutes with an accuracy comparable to that of U.S. FDA approved blood based laboratory HIV EIA tests.
About The Marr Group:
The Marr Group is a private group of companies having a large and diverse number of investments and projects globally, principally in Europe, the Far East, the Middle East and the CIS.
About Calypte Biomedical:
Calypte Biomedical Corporation (www.calypte.com) is a U.S.-based healthcare company focused on the development and commercialization of rapid testing products for sexually transmitted diseases such as the Aware™ HIV-1/2 OMT test that are suitable for use at the point of care and at home. 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, 2006 and its subsequent filings with the SEC.