The company comes clean <g> -
Ciphergen Confirms Use of Its ProteinChip(R) System in Ovarian Cancer Study Published in The Lancet
FREMONT, Calif., Feb. 11 /PRNewswire-FirstCall/ -- In response to investor inquiries, Ciphergen Biosystems, Inc. (Nasdaq: CIPH - news) confirmed today that the ovarian cancer detection study released to the public on February 8 and to be published in The Lancet on February 16 (http://image.thelancet.com/extras/1100web.pdf ) was conducted using Ciphergen's ProteinChip® Biology System to discover and assay the patterns of proteins utilized in the study. Undertaken by the National Cancer Institute and the Food and Drug Administration, this groundbreaking study discovered protein patterns found in the serum of 50 ovarian cancer patients that distinguished them from 50 women without the disease. These patterns were then used to screen another 116 serum samples, 50 from ovarian cancer patients and 66 from healthy women or women with non-malignant disease. Using these protein patterns, all 50 of the cancer patients were correctly classified, including 18 with early stage cancer, and 63 of the 66 women without cancer were correctly classified yielding a sensitivity of 100%, specificity of 98% and positive predictive value of 94%. While this is a preliminary study, this work indicates the potential for using multiple protein biomarkers, and patterns of protein biomarkers, for the early detection of cancer. In many diseases, early detection has a profound impact on survival rates; in ovarian cancer, the five-year survival rate of women with advanced disease is only 35% compared with more than 90% for those with early stage tumors.
``Ciphergen has worked with Drs. Liotta and Petricoin, co-authors of The Lancet paper, in adapting our technology to applications in the emerging field of Clinical Proteomics and we salute this pioneering work. Given that most diseases are biologically complex, the paradigm of diagnostics must inevitably change from single markers to multiple markers and patterns of biomarkers in order to allow the early detection of disease with a high degree of positive predictive value,'' stated Dr. William E. Rich, President and CEO of Ciphergen. ``In our judgment, the key to enabling this vision is to have a commercial platform available to clinical and basic researchers to use in their own laboratories, which combines the rapid discovery and high throughput assay of multiple protein disease biomarkers with sophisticated pattern recognition software analysis. Ciphergen's recently announced ProteinChip Biomarker System is the first commercial product for clinical and basic researchers that integrates both of these critical platform features. We believe this technology has the potential to revolutionize predictive diagnostic medicine.''
Ciphergen's ProteinChip Systems are based on proprietary technology including biochip arrays integrated with SELDI mass spectrometry detection. Since their commercial launch, these systems have been increasingly utilized to discover, validate and assay protein biomarkers in a variety of diseased versus normal biological samples. With over 225 ProteinChip Systems sold to date, laboratories throughout the world such as The Johns Hopkins University School of Medicine and MD Anderson Cancer Center are using Ciphergen technology to conduct wide-ranging studies in the field of cancer, including studies in prostate, breast, colon, lung, liver, pancreatic, bladder, stomach, leukemia as well as cardiovascular, neurodegenerative, and other disease and toxicological studies.
The new ProteinChip® Biomarker System, introduced in December 2001, provides routine, protein expression analysis of crude clinical samples ranging from laser capture micro-dissected cells, biopsies, tissue, urine and serum. The Biomarker System enables de novo protein discovery in days, proteomic pattern validation of large sample sets within weeks and rapid high throughput assays; all on a single system. The system utilizes advanced robotics for high throughput sample preparation and built-in Biomarker Patterns(TM) software to automate pattern recognition-based statistical analysis methods to correlate protein expression patterns of clinical samples with the patient's disease phenotypes for predictive diagnosis of disease and disease pathways.
Ciphergen Biomarker Centers(TM), located in California, Pennsylvania and Denmark, were established to collaborate with the scientific community and pharmaceutical companies to conduct disease, toxicological and pre-clinical and clinical discovery, validation and assay projects as well as to implement larger clinical population studies using Ciphergen technology. The Centers also provide advanced pattern recognition algorithms and biostatistical data analysis and experimental trial design consulting services.
About Ciphergen
Ciphergen develops, manufactures and markets a family of ProteinChip® Systems for clinical, research and process proteomics applications, as well as a broad range of bioseparations media for protein purification through its BioSepra process chromatography division. ProteinChip Systems enable protein discovery, profiling, characterization and assay development to provide researchers with predictive analysis capabilities and a better understanding of biological functions at the protein level. ProteinChip Systems are enabling tools in the emerging field of protein-based biology research, known as proteomics. Proteomics provides a direct approach to understanding the role of proteins in the biology of disease, monitoring disease progression and evaluating the therapeutic effects and side effects of drugs. Ciphergen believes proteomics will be a major focus of biological research by enhancing the understanding of gene function and the molecular basis of disease... |
