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Calypte Announces Execution of a Research and Development Agreement With CDC for Rapid HIV Incidence Test
WEDNESDAY, APRIL 14, 2004 08:02 AM
ALAMEDA, Calif., Apr 14, 2004 /PRNewswire-FirstCall via COMTEX/ -- Calypte Biomedical Corporation (OTC Bulletin Board: 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 it has executed a CRADA -- a Cooperative Research and Development Agreement -- with the Centers for Disease Control and Prevention (CDC) for the development of a unique new HIV rapid blood assay. Like current rapid test assays, the proposed device will be for diagnostic use to detect HIV antibodies, but it will also be for use in population studies to estimate the proportion of HIV-1 infections that have occurred in the last six months. This assay will use a proprietary recombinant protein that will include the amino acid sequences identified from the immunodominant regions of the transmembrane glycoprotein (gp41) identified from multiple subtypes of HIV-1 group M.
The CRADA between Calypte and the CDC provides for the development of a test to estimate the incident HIV infections (of less than 6 months duration) in a population survey. The purpose of the test is to provide a simplified and rapid format that can be performed in resource poor settings and remote outreach locations as a public health surveillance tool. The test should be particularly suitable for settings with limitations in blood collection capacity, laboratory facilities, or specimen transport. The test will be designed to provide invaluable information to Public Health agencies concerning the course of the HIV pandemic, such as identifying populations where new infections are occurring most frequently, allowing agencies to measure the effectiveness of prevention efforts in specific risk groups, and identifying high-incidence cohorts for prevention trials (e.g. microbicide, vaccine etc).
Calypte recently announced that it had obtained a non-exclusive license from the CDC to manufacture a serum enzyme Immunoassay test that can measure the proportion of infections that are recently acquired (less than 6 months) for use in estimating HIV incidence. This assay is a laboratory based technology that is performed on samples from individuals previously tested and found to be positive for HIV antibodies. Such a test could have applications in helping public health officials to determine which populations have the highest rate of new infections, and by extension, where they need to focus their intervention efforts.
Dr. Richard George, President and CEO of Calypte commented that "A simplified and rapid format for serologic assays to estimate HIV incidence is a logical progression and refinement of the currently used, laboratory based EIA. The ability to perform tests for recent infection for public health surveillance purposes in all types of environments will dramatically expand the use and reduce the cost of incidence testing used to monitor the effectiveness of HIV prevention programs."
Tony Cataldo, Executive Chairman of Calypte, stated, "Calypte is pleased to have completed this second agreement with the CDC and to provide science that will allow Public Health agencies to focus their resources on HIV and AIDS prevention measures that can be shown by empirical data to be effective."
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
rgeorge@calypte.com
Investor Relations Contact:
Tim Clemensen
Rubenstein Public Relations
212-843-9337
tclemensen@rubensteinir.com
SOURCE Calypte Biomedical Corporation
CONTACT: Dr. J. Richard George, President and CEO of Calypte Biomedical
Corporation, +1-510-749-5100, rgeorge@calypte.com; or Investor: Tim Clemensen
of Rubenstein Public Relations, +1-212-843-9337, tclemensen@rubensteinir.com,
for Calypte Biomedical Corporation
URL: http://www.calypte.com
http://www.prnewswire.com
Copyright (C) 2004 PR Newswire. All rights reserved.
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Wertpapier: Calypte Biomedical |
High: 0.625
Low: 0.580
Open: 0.610
Change: +0.03
Volume: 202,000
Bid: 0.585
Ask: 0.610
Bid/Ask Size: 1,249,500 / 2,500
52 Wk High: 1.799
52 Wk Low: 0.110
%Change: 5.1%
Market Cap: N/A
Price/Sales: N/A
EPS: $0.00
P/E Ratio: N/A
High: 0.625
Low: 0.580
Open: 0.610
Change: +0.02
Volume: 218,200
Bid: 0.590
Ask: 0.670
Bid/Ask Size: 1,249,500 / 2,500
52 Wk High: 1.799
52 Wk Low: 0.110
%Change: 3.4%
Market Cap: N/A
Price/Sales: N/A
EPS: $0.00
P/E Ratio: N/A