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Calypte's Rockville, Maryland Facility Receives Quality System
Certification to ISO 13485:1996
Corporate Headquarters Moved to Pleasanton, California
PLEASANTON, Calif., June 24 /PRNewswire-FirstCall/ -- Calypte Biomedical
Corporation (OTC:CYPT) (BULLETIN BOARD: CYPT) , a developer, manufacturer and
marketer of HIV diagnostic tests, announced today that its Rockville, Maryland
manufacturing facility has successfully passed its quality system audit to
obtain certification of its quality system to the international standard, ISO
13485:1996. A comprehensive, two-day examination against the requirements of
the ISO 13485 standard was conducted by an independent auditor.
The ISO 13485 standard specifically addresses the application of quality system
principles to medical device products. Regulatory authorities in several
countries around the world such as US FDA, Health Canada, China, the European
Union and others base their requirements for good manufacturing practices (GMP)
on the ISO quality standards. In Canada, conformance to ISO 13485 is a specific
requirement for the maintenance of Calypte's approval for the Cambridge Biotech
HIV-1 Western Blot product. Conformance to the ISO standards is also one of the
many requirements upon which compliance with the European Union Medical Device
and In Vitro Diagnostics Directives and CE Marking rests.
Calypte's Rockville plant holds a biological license approval and PMA approval
from the US FDA for the company's HIV-1 Western Blot tests and houses a
Biosafety Level 3 laboratory for the production of HIV-1 viral materials. The
company is actively transferring the manufacture of its PMA approved HIV-1
Urine EIA test into the Rockville facility.
J. Richard George, Calypte's President and Chief Executive Officer, explained,
"This is the first ISO quality inspection of our Rockville facility and we are
extremely pleased that GMED has granted Calypte certification to ISO 13485. Our
on-going company-wide commitment to quality continues and we believe that
obtaining this certification positions us well to maintain our presence in the
international diagnostics market and to allow us to expand into areas of the
world that utilize the ISO standards as a key regulatory requirement. We
believe that we continue to have the systems in place that allow us to produce
the high quality products our customers around the world have come to expect."
The Company expects to realize on-going savings of approximately $1 million per
year in personnel and occupancy expense as a result of the closure of its
previously ISO certified facility in Alameda, California and the transfer of
manufacturing operations to the Rockville, Maryland location. As part of this
transfer, Calypte has relocated its corporate headquarters to: 5000 Hopyard
Road, Suite 480, Pleasanton, California 94588, 925-730-7200.
About Calypte Biomedical:
Calypte Biomedical Corporation, headquartered in Pleasanton 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: Investor Relations Contact:
Dr. J. Richard George, President and CEO Tim Clemensen
(925) 730-7200 Rubenstein Public Relations
email: Phone: (212) 843-9337
Email:
DATASOURCE: Calypte Biomedical Corporation
CONTACT: Dr. J. Richard George, President and CEO of Calypte Biomedical
Corporation, +1-925-730-7200, ; or Investor Relations - Tim
Clemensen, of Rubenstein Public Relations, +1-212-843-9337,
, for Calypte Biomedical Corporation
Web site: http://www.calypte.com/