Calypte's Rockville, Maryland Facility Receives Quality System Certification to ISO 13485:1996
June 24 2004 - 1:45PM
PR Newswire (US)
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/
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