Calypte Comments On President Bush's Plans for AIDS Relief; Calypte's Safe Blood for Africa Relationship Focuses on HIV Testing
ALAMEDA, Calif., Feb 3, 2003 (BUSINESS WIRE) -- Calypte Biomedical Corporation (OTCBB:CALY), the developer and marketer of the only two FDA approved HIV-1 antibody tests that can be used on urine samples, as well as an FDA approved serum HIV-1 antibody Western blot supplemental test, commented on President George W. Bush's January 31, 2003 speech. His remarks outlined a plan he has submitted to Congress to devote $15 billion toward fighting AIDS via prevention education, testing and treatment.
Tony Cataldo, chairman of Calypte, stated, "Calypte is thrilled with the President's commitment to combat the global AIDS epidemic. We believe the President's agenda reinforces the need for a safe, inexpensive testing device, especially in global communities currently facing AIDS in epidemic proportions. Calypte is seeking to make inroads in several markets, including China and Africa. Recently, we announced our relationship with Safe Blood for Africa Foundation to market and distribute Calypte's urine-based HIV-1 antibody tests in sub-Saharan Africa as a blood donor pre-screening tool. By pre-screening blood donors with urine tests, the foundation can save money and resources, money which can be applied to expanding our coverage and services."
In the remarks on fighting global and domestic HIV/AIDS, President Bush stated that the US Department of Health and Human Services has approved a CLIA (Clinical Laboratory Improvements Amendments) waiver for a rapid blood test currently on the market that provides HIV-1 test results in just 20 minutes.
"The CLIA waiver approval bodes well for all rapid HIV testing products, as it clears the way for moving HIV testing into the field, including emergency rooms, outreach clinics, community-based organizations and physicians' offices," stated Nancy Katz, president and CEO of Calypte. "We believe the FDA has now set a precedent by waiving the requirement for laboratory involvement for a rapid blood test. Our goal is to obtain approval for the Calypte Rapid HIV Urine Test, which will provide similar accuracy and time-to-results in a much safer and less expensive format."
"Our recent experience with the FDA indicates to us that the current administration has a renewed sense of urgency regarding HIV/AIDS related science. We believe the Bush administration will move quickly to review and make available additional rapid tests, especially those based on bodily fluids other than blood," continued Katz.
Calypte is in the process of preparing its FDA Investigational Device Exemption (IDE). Senior Calypte management met with representatives of FDA's Center for Biologics Evaluation and Research (CBER) on October 4, 2002 to review plans for the IDE submission. After completion of US clinical studies, Calypte will be filing its Rapid HIV Urine Test by using a modular pre-market approval (PMA) application approach. After receiving PMA approval, Calypte will file for approval of a CLIA waiver Calypte is filing its Rapid HIV Urine Test by using a modular pre-market approval (PMA) application approach. After receiving PMA approval, Calypte will file for a CLIA waiver.
About Calypte Biomedical
Calypte Biomedical Corporation headquartered in Alameda, California, is a public healthcare company dedicated to the development and commercialization of urine-based diagnostic products and services for Human Immunodeficiency Virus Type 1 (HIV-1), sexually transmitted diseases and other infectious diseases. Calypte's tests include the screening EIA and supplemental Western Blot tests, the only two FDA-approved HIV-1 antibody tests that can be used on urine samples. The company believes that accurate, non-invasive urine-based testing methods for HIV and other infectious diseases may make important contributions to public health by helping to foster an environment in which testing may be done safely, economically, and painlessly. Calypte markets its products in countries worldwide through international distributors and strategic partners. Current product labeling including specific product performance claims can be found on our website at www.calypte.com.
About Safe Blood for Africa Foundation
The Safe Blood for Africa Foundation is a not-for-profit corporation whose mission is to help prevent the spread of HIV/AIDS throughout 34 countries in sub-Saharan Africa. The organization is working with such groups as the World Bank, USAID, UNAIDS, and the World Health Organization (WHO). The Safe Blood for Africa Foundation estimates that of the 6 million blood transfusions performed annually in sub-Saharan Africa, approximately half of the transfused materials have not been tested for infectious diseases. As the Safe Blood for Africa Foundation's testing responsibility grows to cover all of sub-Saharan Africa, the number of blood transfusions performed is anticipated to grow to 12 million transfusions per year. The Safe Blood for Africa Foundation estimates that less than half of sub-Saharan African countries have adopted a national blood transfusion policy and less than one third of the countries have policies to limit HIV infection through blood transfusions. Since the HIV prevalence in many of these countries exceeds 20%, blood transfusions account for an ever-increasing cause of new infections.
Statements in this press release that are not historical facts are forward-looking statements, including statements regarding announcements of financial results and presentations by the Company. 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, our ability to obtain additional financing that will allow us to continue our current and future operations and whether demand for our product and testing service in domestic and international markets will continue to expand. 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-K for the year ended December 31, 2001 and its subsequent filings with the SEC.
CONTACT: Calypte Biomedical Corporation
Nancy Katz, President & CEO, 510/749-5100
nkatz@calypte.com
or
Lippert/Heilshorn & Associates
Investor Relations Contact:
Brendan Lahiff/Kirsten Chapman, 415/433-3777
brendan@lhai-sf.com
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