National Cancer Institute's Early Detection Research Network Reports Platform and Clinical Reproducibility of Ciphergen's SELDI
January 18 2005 - 9:00AM
PR Newswire (US)
National Cancer Institute's Early Detection Research Network
Reports Platform and Clinical Reproducibility of Ciphergen's SELDI
ProteinChip(R) System for Detection of Prostate Cancer Study
Results Reported in Clinical Chemistry FREMONT, Calif., Jan. 18
/PRNewswire-FirstCall/ -- Ciphergen Biosystems, Inc. (NASDAQ:CIPH)
announced today that the National Cancer Institute's Early
Detection Research Network (NCI-EDRN) reported completion of the
first phase of its development of a proteomics platform using
Ciphergen's SELDI ProteinChip(R) System for the detection of
prostate cancer. The study, which was published in the January
issue of Clinical Chemistry, first measured the intra- and
inter-laboratory reproducibility of serum profiling and then
measured the inter-laboratory reproducibility of sample
classification of blinded patient samples. In the study, 28 blinded
samples were independently analyzed by each of six participating
institutions, and each institution was able to correctly classify
all 28 samples. The goal of the collaborative project was to use
state-of-the-art protein profiling technology to develop and
validate high-throughput screening methods for early detection of
prostate cancer. The successful validation study of SELDI profiling
included an initial phase to determine reproducibility of the SELDI
assay as a specific response to questions of platform
reproducibility. This was a necessary first step towards
demonstrating the clinical viability of the assay. The study
demonstrated that under standardized operating procedures
(instrument calibration and standardization protocols), they were
able to achieve across-laboratory reproducibility of SELDI-TOF-MS
analysis. "Mass spectrometry is currently enjoying a renaissance
period with potential application in clinical biomarker discovery
and as a diagnostic tool. For the adoption of analytical
instrumentation into a diagnostic platform and in discovery
applications in which hundreds of samples are processed with the
goal of identifying population specific protein changes, two
essential qualities for a successful technology are reproducibility
and portability. In this study, we established standard protocols
in six laboratories that allowed each of six SELDI-TOF-MS systems
to obtain 'identical' protein expression profiles when analyzing
the same human serum sample. This result establishes for the first
time that mass spectrometry, under the conditions utilized in this
study, can result in reproducible output. These and other issues
are slated to be examined in a multi-institutional collaboration
funded by the NCI's Early Detection Network," stated O. John
Semmes, Ph.D., Scientific Director, Virginia Prostate Center,
Director, Center for Biomedical Proteomics and Associate Professor,
Department of Microbiology and Molecular Cell Biology. "We are very
excited about these promising results which demonstrate that
SELDI-TOF-MS is reproducible and accurate when standardized
operating procedures are followed similar to those followed in a
CLIA certified laboratory. It is our ultimate goal to translate our
biomarker discovery programs covering a range of life-threatening
diseases into commercially viable diagnostic assays that could lead
to earlier detection of disease and improved health outcomes," said
Gail Page, President of Ciphergen's Diagnostics Division.
Institutions participating in the NCI-EDRN study were: Department
of Microbiology & Molecular Cell Biology, Virginia Prostate
Center, Eastern Virginia Medical School; Fred Hutchison Cancer
Center; Center for Prostate Disease Research, Department of
Surgery, Uniformed Services University of the Health Sciences;
University of Pittsburgh Cancer Institute, Hillman Cancer Center;
Cancer Therapy and Research Center, Institute for Drug Development;
Department of Pathology, Johns Hopkins Medical Institutes;
Department of Pathology, University of Alabama at Birmingham;
Cancer Biomarkers Research Group, Division of Cancer Prevention,
National Cancer Institute; and Department of Medicine, University
of Texas Health Sciences Center. 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. 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 a future
multi-institutional collaboration funded by the NCI's Early
Detection Network, the use of ProteinChip technology to discover
useful protein biomarkers that can act as novel drug targets or
disease markers, develop and commercialize clinical diagnostics
that improve patient care, the ability to provide services that
lead to improved toxicology assays and diagnostic assays, and
statements regarding our Diagnostics Division. 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 novel drug targets, diagnostic or toxicology assays, 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 9,
2004, for further information regarding these and 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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