Calypte Announces License From CDC for HIV Incidence Test
4/12/2004 9:06:00 AM
ALAMEDA, Calif., Apr 12, 2004 /PRNewswire-FirstCall via COMTEX/ -- Calypte Biomedical Corporation (CYPT) , a company engaged in developing rapid tests for HIV diagnosis and 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, announced today that the Centers for Disease Control and Prevention (CDC) has granted Calypte a worldwide, non-exclusive license enabling Calypte to use technologies developed by the CDC to manufacture and commercialize a serum enzyme immunoassay (HIV1 -EIA) that can be used to estimate the proportion of HIV infections that are recently acquired in a population (infections occurring in the last 6-8 months). Included in the license are rights to use the proprietary synthetic peptide antigen (called the BED antigen) based on sequences from the immunodominant region of the glycoprotein gp41 of multiple subtypes of HIV-1.
The HIV-1 incidence test has been the subject of numerous publications describing its usefulness as an epidemiological measurement to track the expansion of the HIV pandemic into susceptible populations. The laboratory assays can be used to identify those regions and the populations within those regions where HIV transmission is occurring most recently. This knowledge will allow prevention resources to be focused on programs that have been shown to be effective. The HIV-1 EIA is currently made by the CDC and is currently being validated in a number of public health laboratories worldwide as part of the Serologic Testing Algorithm for Recent HIV Seroconversion (STARHS). Data collected to date is encouraging for the surveillance use of this assay and final evaluation and validation is expected to be completed in the next few months. Once Calypte's production capabilities are in place, the CDC will no longer supply this product.
According to Dr. Richard George, President and CEO of Calypte, "The use of serologic assays to estimate HIV incidence has been used for some time and has been proven to be an effective tool in identifying populations most at risk for HIV. It will allow Public Health agencies to more efficiently use their resources by focusing their efforts on those groups having the greatest need using programs that are effective for that particular risk group."
Tony Cataldo, Executive Chairman of Calypte, stated "The amount of funding being made available to identify and treat HIV infected people is unprecedented. Calypte is very pleased to be able to assist the CDC in making this valuable assay more available to those countries where HIV infection is endemic. We expect that the efficiencies resulting from the consolidation of our manufacturing operations at our Rockville, Maryland facility will enable us to provide a stable, high-quality supply of this test for the foreseeable future, and that its availability will allow more efficient use of the money now being granted to countries around the world to fight HIV and AIDS."
About Calypte Biomedical:
Calypte Biomedical Corporation, headquartered in Alameda, California, is a public healthcare company dedicated to the development and commercialization of in vitro diagnostic tests, primarily for the detection of antibodies to Human Immunodeficiency Virus (HIV), and other sexually transmitted and infectious diseases. Calypte's currently marketed laboratory-based tests include an enzyme immunoassay (EIA) HIV-1 antibody screening test and an HIV-1 antibody western blot supplemental test, the only two FDA-approved HIV-1 antibody tests for use on urine samples, as well as an FDA-approved serum HIV- 1 antibody western blot supplemental test. Calypte is actively engaged in developing new test products for the rapid detection of HIV and other infectious diseases. 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 infectious diseases may make important contributions to public health.
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 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 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-KSB for the year ended December 31, 2003 and its subsequent filings with the SEC.
Company Contact:
Dr. J. Richard George, President and CEO
(510) 749-5100
email: rgeorge@calypte.com
Investor Relations Contact:
Tim Clemensen
Rubenstein Investor Relations
Phone: 212-843-9337
Email: tclemensen@rubensteinir.com
SOURCE Calypte Biomedical Corporation
Dr. J. Richard George, President and CEO, Calypte Biomedical
Corporation, +1-510-749-5100, rgeorge@calypte.com; or Investor Relations - Tim
Clemensen, Rubenstein Investor Relations, +1-212-843-9337,
tclemensen@rubensteinir.com, for Calypte
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