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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/