Data on Aware2(TM) HIV-1/2 Rapid Test Research Equals or Exceeds U.S. FDA Sensitivity Standards LAKE OSWEGO, Ore., Aug. 14 /PRNewswire-FirstCall/ -- Calypte Biomedical Corporation (Amex: HIV; the "Company"), 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 it will present an abstract entitled "Initial evaluations of a novel rapid test for HIV-1/2 antibodies in blood or oral fluid," Abstract: CDB0076, on its research to develop a new HIV 1/2 rapid test format for use on whole blood and plasma and oral fluid specimens, at the XVI International AIDS Conference in Toronto, Canada on August 13th-18th. The data contained in the Abstract relates to the Company's second-generation rapid testing platform (Aware2(TM) prototype, which it is currently being developed as an HIV screening test. The unique platform, is based on technology licensed from Ani Biotech Oy of Finland, and allows the Company to enter new markets, including the U.S., where its current Aware(TM) line of rapid tests is not available. The Company said that preliminary results of an internally-conducted study for the Aware2(TM) HIV-1/2 rapid blood test's sensitivity equals or exceeds that of most U.S. FDA approved EIA tests. The Company's current Aware(TM) HIV-1/2 rapid blood and oral fluid tests also exceed most U.S. FDA approved EIA tests. The study demonstrated excellent concordance for matched blood- based and oral fluid specimens with the Aware2(TM) HIV-1/2 prototype test. These findings are the first step in what the Company hopes will culminate in a formal submission to the U.S. FDA for its Aware2(TM) HIV-1/2 rapid BSP (blood) and OMT (oral fluid) tests. Dr. Ron Mink, Calypte's Chief Scientific Officer, stated, "The data we have assembled are very encouraging, in terms of pre-clinical performance characteristics. The test is easy to use and versatile, demonstrated by its ability to detect antibodies to HIV in either oral fluid or blood. The visualizing agent is not part of the test strip, which differentiates it from lateral flow HIV tests currently available and appears to improve sensitivity. We are pleased to be able to share our findings with participants at the XVI International AIDS Conference in Toronto." Roger I. Gale, Calypte's Chairman and Chief Executive Officer commented, "As Dr. Mink noted, the initial results are encouraging. This format is quite sensitive. The Aware2(TM) line is an important opportunity for us. An U.S. FDA advisory panel has recently supported the development of a process to bring a HIV OTC test to the U.S. market and the Aware2(TM) platform is particularly suitable for OTC applications." Mr. Gale continued, "Calypte is uniquely poised to deliver to the U.S. OTC markets rapid tests for HIV and other diseases of public health interest. We plan to use the Aware2(TM) platform to develop a line of diagnostic tests for STDs, with the initial test expected to be syphilis. Initial feasibility research is underway in collaboration with the Centers for Disease Control and Prevention (CDC)." About XVI International AIDS Conference: This Conference (http://www.aids2006.org), which is held every two years, is the world's largest HIV/AIDS conference. It is being held in Toronto Canada from August 13-18, 2006. Its purpose is to provide an international, open and independent forum for the exchange of ideas, knowledge and research on HIV/AIDS -- to inform, as well as to strengthen prevention, treatment and care efforts worldwide. An estimated 20,000 participants including scientists, health care providers, political, community and business leaders, journalists, government, non-governmental and intergovernmental representatives, and people living with HIV/AIDS are expected to attend. Calypte will have a commercial exhibit at the conference, where its products will be available for inspection to potential customers and will have its scientists available to answer questions about its newest technology. The Conference program includes abstract-driven oral and poster sessions, controversies and common ground sessions, bridging sessions, symposia and skills building workshops, along with innovative mechanisms to broaden the reach and impact of this event, particularly in the developing world where the epidemic is most entrenched. About Calypte Biomedical: Calypte Biomedical Corporation (http://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 Private Securities Litigation Reform Act of 1995. 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 develop and commercialize its test products, 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: Investor Relations Contact: Theodore R. Gwin, Tim Clemensen, Chief Financial Officer Rubenstein Investor Relations (971) 204-0282 Phone: (212) 843-9337 email: tgwin@calypte.com email: tclemensen@rubensteinir.comSOURCE Calypte Biomedical Corporation -0- 08/14/2006 /CONTACT: Company Contact: Theodore R. Gwin, Chief Financial Officer, ofCalypte Biomedical Corporation, +1-971-204-0282, tgwin@calypte.com; InvestorRelations: Tim Clemensen, of Rubenstein Investor Relations for CalypteBiomedical Corporation, +1-212-843-9337, tclemensen@rubensteinir.com/ /Web site: http://www.calypte.com http://www.aids2006.org / (HIV)CO: Calypte Biomedical CorporationST: Oregon, CanadaIN: BIO MTC HEA IDCSU: SVY TDSAM-- NYM087 --9578 08/14/2006 07:30 EDT http://www.prnewswire.com |