Calypte Biomedical Submits Investigational Device Exemption Application for HIV-1 Rapid Blood Test
07 November 2003 - 12:00AM
PR Newswire (US)
Calypte Biomedical Submits Investigational Device Exemption
Application for HIV-1 Rapid Blood Test ALAMEDA, Calif., Nov. 6
/PRNewswire-FirstCall/ -- Calypte Biomedical Corporation (BULLETIN
BOARD: CYPT) , the developer and marketer of the only two FDA
approved HIV-1 antibody tests for use with urine samples, announced
today that it is submitting an application with the U.S. Food and
Drug Administration (FDA) for an Investigational Device Exemption
(IDE) for its HIV-1 lateral flow antibody Rapid Blood Test to be
performed on whole blood. This represents the Company's first
application in connection with several rapid HIV diagnostic tests
the Company has under development. The Company expects to submit a
similar application for its urine-based HIV-1 Rapid Test sometime
next year. "This application represents an important step in our
attempt to penetrate the U.S. market for our suite of Rapid Test
products," said Tony Cataldo, Calypte Biomedical's Chairman. "While
we believe that near-term international opportunities for our
Urine-based Rapid Test (once approved/commercially viable) will
drive revenue growth, ultimately we feel that the North American
market will represent a potential for substantial commercial
opportunity for our Urine-based Rapid Test. We believe our ability
to market a blood-based Rapid Test product will raise awareness
among the U.S. medical community for our suite of Rapid Test
products and ultimately shorten the sales cycle for our urine-based
HIV product. In addition, we anticipate that there will be
opportunities to cross-sell our blood related testing products to
the medical community, as it acts as an excellent confirmatory test
for urine." Under federal regulations, the FDA can authorize the
use of an investigational test in the treatment of patients with
serious or life-threatening conditions when no comparable or
satisfactory alternative exists. The Company believes that its
HIV-1 Rapid Blood Test may be cheaper than similar products
currently being marketed in the U.S. About Calypte Biomedical
Corporation 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, as well as an
FDA-approved serum HIV-1 antibody Western Blot 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. Current product
labeling including specific product performance claims can be found
at http://www.calypte.com/. 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, 2002 and
its subsequent filings with the SEC. CONTACT: Tim Clemensen, of
Rubenstein IR, +1-212-843-9337, , for Calypte Biomedical
Corporation DATASOURCE: Calypte Biomedical Corporation CONTACT: Tim
Clemensen, of Rubenstein IR, +1-212-843-9337, , for Calypte
Biomedical Corporation Web site: http://www.calypte.com/
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