Wednesday 3 December 2003
2:00pm - 2:30pm at Lecture Room No 2
Ciphergen Biosystems Tutorial Lecture


A novel multi-biomarker panel for diagnosis of early stage ovarian cancer

Ciphergen’s approach to diagnostic development relies on two characteristics: clinical utility and assay precision. The former determines whether a physician will need to order the test and encompasses clinical indication and diagnostic performance (sensitivity, specificity, positive and negative predictive values), while the latter determines whether a physician will order the test and encompasses reproducibility and systematic variability. Ciphergen’s approach to diagnostic development therefore relies on defining an important clinical question and developing an appropriate sample set to answer that clinical question. The samples are processed in a routine, automated fashion so as to minimize variability. Peak information is obtained and analyzed using appropriate statistical principles. Rigorous training, testing, and validation of classification algorithms are performed to determine the sensitivity and specificity. The biomarkers are purified and identified and, when possible, the performance of individual biomarkers is validated cross-platform. Assays with increasing precision are developed and, finally, the classification model is tested on expanded patient sample sets. This presentation will describe an example of this paradigm applied to the discovery of biomarkers for ovarian cancer.

Rapid discovery and identification of a tissue-specific tumor biomarker from 39 human cancer cell lines using the SELDI ProteinChip platform. Biochemical and Biophysical Research Communications, 309, 18-25, (2003) Shiwa, M., Nishimura, Y., Wakatabe, R., Fukawa, A., Arikuni, H., Ota, H., Kato, Y., Yamori, T.

Haptoglobin-alpha Subunit as a Potential Serum Biomarker in Ovarian Cancer: Identification and Characterization Using Proteomic Profiling and Mass Spectrometry. Clinical Cancer Research, 9, 2904-2911, (2003) Ye, B., Cramer, D.W., Skates, S.J., Gygi, S.P., Pratomo, V., Fu, L., Horick, N.K., Licklider, L.J., Schorge, J.O., Berkowitz, R.S., Mok, S.C.

Proteomic Applications for the Early Detection of Cancer. Nature Reviews, 3, 267-272, (2003) Wulfkuhle, J.D., Liotta, L.A., Petricoin, E.F.

Proteomic Approaches to Tumor Marker Discovery. Archives of Pathology and Laboratory Medicine, 126, 1518-1526, (2002) Rai, A.J., Zhang, Z., Rosenzweig, J., Shih, L.-M., Pham, T., Fung, E.T., Sokoll, L.J., Chan, D.W.

Serum protein fingerprinting coupled with a pattern-matching algorithm distinguishes prostate cancer from benign prostate hyperplasia and healthy men. Cancer Research 62, 3609-3614, (2002) Adam, B., Qu, Y., Davis, J.W., Ward, M.D., Clements, M.A., Cazares, L.H., Semmens, O.J., Schellhammer, PF, Yasui, Y., Ziding, F., Wright, G.