Business Wire - October 9, 2002
Based on last week's meeting, the company plans to accelerate the development of its new Rapid HIV Urine Test by using a modular pre-market approval (PMA) application approach. This method could speed the rate at which the FDA approves the PMA, as the process is broken into definable sections, which can be submitted and reviewed as Calypte works on the completion of the next module. With the completion of the pre-IDE meeting, the company is moving forward with its planned IDE submission in December 2002 with the initiation of clinical studies targeted for February 2003.
Calypte's Director of Regulatory Affairs, Don Kafader, stated, "We are delighted with the FDA's openness to work with us on this important new diagnostic and the tone of the meeting. Meeting directly with the FDA establishes a firm groundwork to facilitate the initiation of our clinical studies in the United States and for the early submission and review of our final PMA application next year. The face-to-face meeting allowed us to obtain clear feedback and constructive suggestions from the FDA on our proposed study design for the Rapid Test."
Calypte President and CEO, Nancy Katz, said, "A Rapid HIV Urine Test is a unique product that can help address the HIV/AIDS crisis worldwide. Studies have shown that more people are likely to get tested for HIV/AIDS when a urine testing alternative is offered since many individuals prefer not to have a blood sample taken. The Rapid HIV Urine Test results can be available in less than 30 minutes, providing results to more patients, more quickly, leading to better opportunities for counseling and treatment."
Katz added, "Internationally, this product provides safe, non-invasive results on the spot, thereby eliminating costly travel and lab expenses. In the U.S., current estimates from the Center for Disease Control and Prevention (CDC) report that approximately 25-30% of people tested positively for HIV does not return to obtain their results. We believe these facts are part of the reason why our Rapid Test was so well received at the World Conference on AIDS in Barcelona and the United States Conference on AIDS (USCA) in Anaheim, CA."
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. When compared with existing blood-based tests, our testing algorithms are non-invasive, easier to use, less expensive and have significantly less risk than blood-based testing, and they have 99.7% sensitivity in subjects previously identified as HIV-1 infected and 100% specificity in subjects at low risk when combined with the urine-based Western Blot supplemental test. 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.
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, our ability to obtain additional financing and access funds from our existing financing arrangements 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: Lippert / Heilshorn & Associates, Inc. Brendan Lahiff, 415/433-3777
SOURCE: Calypte Biomedical Corporation
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