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Calypte Announces Execution of a Research and Development
Agreement With CDC for Rapid HIV Incidence Test
ALAMEDA, Calif., April 14 /PRNewswire-FirstCall/ -- Calypte Biomedical
Corporation (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
Investor Relations Contact:
Tim Clemensen
Rubenstein Public Relations
212-843-9337
DATASOURCE: Calypte Biomedical Corporation
CONTACT: Dr. J. Richard George, President and CEO of Calypte Biomedical
Corporation, +1-510-749-5100, ; or Investor: Tim Clemensen
of Rubenstein Public Relations, +1-212-843-9337, ,
for Calypte Biomedical Corporation
Web site: http://www.calypte.com/