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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