Ciphergen Receives Medical Device Certification in China
March 04 2004 - 9:00AM
PR Newswire (US)
Ciphergen Receives Medical Device Certification in China
ProteinChip(R) System Approved by the State Food and Drug
Administration FREMONT, Calif., March 4 /PRNewswire-FirstCall/ --
The Ciphergen Diagnostics Division of Ciphergen Biosystems, Inc.
announced today that the ProteinChip System has been certified
(certificate number SFDA(I) 20032400768) by the State Food and Drug
Administration (SFDA) in China as a Medical Device, a result of
demonstrating that the ProteinChip System has met the quality
control requirements of the SFDA. This is the first step required
to delivering diagnostic tests in China using the ProteinChip
System and it is the first time that a mass spectrometer has been
approved as a medical device in China. Future individual diagnostic
tests will have to be individually cleared by the SFDA based on
their performance in specific clinical trials, but the core
ProteinChip diagnostic system itself will not have to be
re-certified for each test. "We are extremely pleased to have
received this designation from the SFDA," stated Gail Page,
President of Ciphergen's Diagnostics Division. "This represents one
more step in preparing the ProteinChip System for diagnostic use on
a worldwide basis." William E. Rich, President and CEO of Ciphergen
Biosystems, Inc. said, "Programs initiated by both our Biosystems
and Diagnostics Divisions have led to Ciphergen being a world
leader in protein biochip-based biomarker discovery, and we now
look forward to pioneering the translation ofprotein biomarkers
into commercial clinical diagnostics around the world." About
Ciphergen Ciphergen's Diagnostics Division is dedicated to the
discovery of protein biomarkers and panels of biomarkers and their
development into protein molecular diagnostic tests that improve
patient care; and to providing collaborative R&D services
through its Biomarker Discovery Center(R) laboratories for
biomarker discovery for new diagnostic tests as well as
pharmacoproteomic services for improved drug toxicology, efficacy
and theranostic assays. Ciphergen's Biosystems Division develops,
manufactures and markets a family of ProteinChip(R) Systems and
services for clinical, research, and process proteomics
applications, as well as a broad range of bioseparations media for
protein purification and large scale production. ProteinChip
Systems enable protein discovery, characterization, identification
and assay development to provide researchers with predictive,
multi-marker assay capabilities and a better understanding of
biological function at the protein level. Additional information
about Ciphergen can be found at http://www.ciphergen.com/. Safe
Harbor Statement Note Regarding Forward-Looking Statements: For
purposes of the Private Securities Litigation Reform Act of 1995
(the "Act"), Ciphergen disclaims any intent or obligation to update
these forward-looking statements, and claims the protection of the
Safe Harbor for forward-looking statements contained in the Act.
Examples of such forward-looking statements include statements
regarding potential and future diagnostic tests, the use of
ProteinChip technology to discover useful protein biomarkers,
develop and commercialize clinical diagnostics that improve patient
care, and the ability to provide services that lead to improved
toxicology assays and diagnostic assays. Actual results may differ
materially from those projected in such forward-looking statements
due to various factors, including the ProteinChip technology's
ability to validate and/or develop protein biomarkers as diagnostic
or toxicology assays, the Company's ability to achieve SFDA
approval for future individual diagnostic tests, and the Company's
ability to successfully commercialize such tests. Investors should
consult Ciphergen's filings with the Securities and Exchange
Commission, including its Form 10-Q dated November 14, 2003, for
further information regarding these and the other risks of the
Company's business. NOTE: Ciphergen, ProteinChip and Biomarker
Discovery Center are registered trademarks of Ciphergen Biosystems,
Inc. DATASOURCE: Ciphergen Biosystems, Inc. CONTACT: Sue
Carruthers, Investor Relations of Ciphergen Biosystems, Inc.,
+1-510-505-2297 Web site: http://www.ciphergen.com/
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