National Cancer Institute reports first phase completion of proteomics
platform for early detection of prostate cancer
18 January 2005
Ciphergen Biosystems, Inc. has announced 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® 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, PhD, 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.
Additional information about Ciphergen can be found at
www.ciphergen.com |
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