REFERENCES

Check E. 2004. Proteomics and cancer: Running before we can walk? Nature (429), 6991:496-497.

Ellis IO, et al. 2004. Best Practice No 176: Updated recommendations for HER2 testing in the UK. Journal of Clinical Pathology 57:233-237.

FDA (Food and Drug Administration), Center for Devices and Radiological Health, OVID (Office of In-Vitro Devices), Analyte Specific Reagents; Small Entity Compliance Guidance; Guidance for Industry.

Letter from OIVD to Roche Molecular Diagnostics Re: AmpliChip, http://www.fda.gov/cdrh/oivd/amplichip.html.

Medical Devices; Classification/Reclassification; Restricted Devices; Analyte Specific Reagents, 61 Fed. Reg. at 10,484. March 14, 1996.

Michiels S, et al. 2005. Prediction of cancer outcome with microarrays: a multiple random validation strategy. Lancet 365(9458):488-492.

Paik S, et al. 2002. Real-world performance of HER2 testing—National Surgical Adjuvant Breast and Bowel Project experience. Journal of the National Cancer Instititute 94(11):852-854.

Perez EA, et al. 2006. HER2 testing by local, central, and reference laboratories in specimens from the North Central Cancer Treatment Group N9831 intergroup adjuvant trial. Journal of Clinical Oncology 24(19):3032-3038.

Petricoin EF, et al. 2002. Use of proteomic patterns in serum to identify ovarian cancer. Lancet 359(9306):572-577.

Pharmaceutical Research and Manufacturers of America Biomarker Working Group presentation (2004). FDA Advisory Committee Meeting.

Reddy JC, et al. 2006. Concordance between central and local laboratory HER2 testing from a community-based clinical study. Clinical Breast Cancer 7(2):153-157.

Rhodes A, et al. 2004. The use of cell line standards to reduce HER-2/neu assay variation in multiple European cancer centers. American Journal of Clinical Pathology 122:51-60.

Simon R, et al. 2003. Pitfalls in the use of DNA microarray data for diagnostic and prognostic classification. Journal of the National Cancer Institute 95(1):14-18.

Van de Vijver MJ, et al. 2002. Agene-expressionsignatureasapredictorofsurvivalinbreastA gene-expression signature as a predictor of survival in breast cancer. New England Journal of Medicine 347(25):1999-2009.

Wagner JA. 2002. Overview of biomarkers and surrogate endpoints in drug development. Disease Markers 18(2):41-46.



The National Academies | 500 Fifth St. N.W. | Washington, D.C. 20001
Copyright © National Academy of Sciences. All rights reserved.
Terms of Use and Privacy Statement



Below are the first 10 and last 10 pages of uncorrected machine-read text (when available) of this chapter, followed by the top 30 algorithmically extracted key phrases from the chapter as a whole.
Intended to provide our own search engines and external engines with highly rich, chapter-representative searchable text on the opening pages of each chapter. Because it is UNCORRECTED material, please consider the following text as a useful but insufficient proxy for the authoritative book pages.

Do not use for reproduction, copying, pasting, or reading; exclusively for search engines.

OCR for page 92
Developing Biomarker-Based Tools for Cancer Screening, Diagnosis, and Treatment: The State of the Science, Evaluation, Implementation, and Economics REFERENCES Check E. 2004. Proteomics and cancer: Running before we can walk? Nature (429), 6991:496-497. Ellis IO, et al. 2004. Best Practice No 176: Updated recommendations for HER2 testing in the UK. Journal of Clinical Pathology 57:233-237. FDA (Food and Drug Administration), Center for Devices and Radiological Health, OVID (Office of In-Vitro Devices), Analyte Specific Reagents; Small Entity Compliance Guidance; Guidance for Industry. Letter from OIVD to Roche Molecular Diagnostics Re: AmpliChip, http://www.fda.gov/cdrh/oivd/amplichip.html. Medical Devices; Classification/Reclassification; Restricted Devices; Analyte Specific Reagents, 61 Fed. Reg. at 10,484. March 14, 1996. Michiels S, et al. 2005. Prediction of cancer outcome with microarrays: a multiple random validation strategy. Lancet 365(9458):488-492. Paik S, et al. 2002. Real-world performance of HER2 testing—National Surgical Adjuvant Breast and Bowel Project experience. Journal of the National Cancer Instititute 94(11):852-854. Perez EA, et al. 2006. HER2 testing by local, central, and reference laboratories in specimens from the North Central Cancer Treatment Group N9831 intergroup adjuvant trial. Journal of Clinical Oncology 24(19):3032-3038. Petricoin EF, et al. 2002. Use of proteomic patterns in serum to identify ovarian cancer. Lancet 359(9306):572-577. Pharmaceutical Research and Manufacturers of America Biomarker Working Group presentation (2004). FDA Advisory Committee Meeting. Reddy JC, et al. 2006. Concordance between central and local laboratory HER2 testing from a community-based clinical study. Clinical Breast Cancer 7(2):153-157. Rhodes A, et al. 2004. The use of cell line standards to reduce HER-2/neu assay variation in multiple European cancer centers. American Journal of Clinical Pathology 122:51-60. Simon R, et al. 2003. Pitfalls in the use of DNA microarray data for diagnostic and prognostic classification. Journal of the National Cancer Institute 95(1):14-18. Van de Vijver MJ, et al. 2002. Agene-expressionsignatureasapredictorofsurvivalinbreastA gene-expression signature as a predictor of survival in breast cancer. New England Journal of Medicine 347(25):1999-2009. Wagner JA. 2002. Overview of biomarkers and surrogate endpoints in drug development. Disease Markers 18(2):41-46.