메뉴 건너뛰기




Volumn 2, Issue 10-11, 2008, Pages 1378-1385

Bringing diagnostic technologies to the clinical laboratory: Rigor, regulation, and reality

Author keywords

Biomarker development; FDA filing

Indexed keywords

BIOLOGICAL MARKER; CA 125 ANTIGEN; OSTEOPONTIN; PROLACTIN;

EID: 64649094843     PISSN: 18628346     EISSN: None     Source Type: Journal    
DOI: 10.1002/prca.200780170     Document Type: Review
Times cited : (11)

References (36)
  • 1
    • 2942535913 scopus 로고    scopus 로고
    • Proteomics and cancer: Running before we can walk?
    • Check, E., Proteomics and cancer: Running before we can walk? Nature 2004, 429, 496-497.
    • (2004) Nature , vol.429 , pp. 496-497
    • Check, E.1
  • 2
    • 0029795892 scopus 로고    scopus 로고
    • Adenomatous polyposis coli and translational medicine
    • Geraghty, J., Adenomatous polyposis coli and translational medicine. Lancet 1996, 348, 422.
    • (1996) Lancet , vol.348 , pp. 422
    • Geraghty, J.1
  • 3
    • 1542374707 scopus 로고    scopus 로고
    • Translating basic discoveries into better health care: The APM's recommendations for improving translational research
    • Crist, T. B., Schafer, A. I., Walsh, R. A., Translating basic discoveries into better health care: The APM's recommendations for improving translational research. Am. J. Med. 2004, 116, 431-434.
    • (2004) Am. J. Med , vol.116 , pp. 431-434
    • Crist, T.B.1    Schafer, A.I.2    Walsh, R.A.3
  • 4
    • 34547604174 scopus 로고    scopus 로고
    • The mismeasurement of science
    • Lawrence, P. A., The mismeasurement of science. Curr. Biol. 2007, 17, R583-R585.
    • (2007) Curr. Biol , vol.17
    • Lawrence, P.A.1
  • 5
    • 0037012469 scopus 로고    scopus 로고
    • Osteopontin as a potential diagnostic biomarker for ovarian cancer
    • Kim, J. H., Skates, S. J., Uede, T., Wong, K. K. et al., Osteopontin as a potential diagnostic biomarker for ovarian cancer. JAMA 2002, 287, 1671-1679.
    • (2002) JAMA , vol.287 , pp. 1671-1679
    • Kim, J.H.1    Skates, S.J.2    Uede, T.3    Wong, K.K.4
  • 7
    • 19644388098 scopus 로고    scopus 로고
    • Serum protein markers for early detection of ovarian cancer
    • Mor, G., Visintin, I., Lai, Y., Zhao, H. et al., Serum protein markers for early detection of ovarian cancer. Proc. Natl. Acad. Sci. USA 2005, 102, 7677-7682.
    • (2005) Proc. Natl. Acad. Sci. USA , vol.102 , pp. 7677-7682
    • Mor, G.1    Visintin, I.2    Lai, Y.3    Zhao, H.4
  • 8
    • 4143067096 scopus 로고    scopus 로고
    • Three biomarkers identified from serum proteomic analysis for the detection of early stage ovarian cancer
    • Zhang, Z., Bast, R. C., Jr., Yu, Y., Li, J. et al., Three biomarkers identified from serum proteomic analysis for the detection of early stage ovarian cancer. Cancer Res. 2004, 64, 5882-5890.
    • (2004) Cancer Res , vol.64 , pp. 5882-5890
    • Zhang, Z.1    Bast Jr., R.C.2    Yu, Y.3    Li, J.4
  • 9
    • 33747030845 scopus 로고    scopus 로고
    • Protein biomarker discovery and validation: The long and uncertain path to clinical utility
    • Rifai, N., Gillette, M. A., Carr, S. A., Protein biomarker discovery and validation: The long and uncertain path to clinical utility. Nat. Biotechnol. 2006, 24, 971-983.
    • (2006) Nat. Biotechnol , vol.24 , pp. 971-983
    • Rifai, N.1    Gillette, M.A.2    Carr, S.A.3
  • 11
    • 33745954240 scopus 로고    scopus 로고
    • Priming the pipeline
    • Diagnostics and biomarker development
    • Phillips, K. A., Van Bebber, S., Issa, A. M., Diagnostics and biomarker development: Priming the pipeline. Nat. Rev. Drug Discov. 2006, 5, 463-469.
    • (2006) Nat. Rev. Drug Discov , vol.5 , pp. 463-469
    • Phillips, K.A.1    Van Bebber, S.2    Issa, A.M.3
  • 12
    • 34249043284 scopus 로고    scopus 로고
    • Intelligent bioprocessing for haemotopoietic cell cultures using monitoring and design of experiments
    • Lim, M., Ye, H., Panoskaltsis, N., Drakakis, E. M. et al., Intelligent bioprocessing for haemotopoietic cell cultures using monitoring and design of experiments. Biotechnol. Adv. 2007, 25, 353-368.
    • (2007) Biotechnol. Adv , vol.25 , pp. 353-368
    • Lim, M.1    Ye, H.2    Panoskaltsis, N.3    Drakakis, E.M.4
  • 13
    • 0037116832 scopus 로고    scopus 로고
    • Use of proteomic patterns in serum to identify ovarian cancer
    • Petricoin, E. F., Ardekani, A. M., Hitt, B. A., Levine, P. J. et al., Use of proteomic patterns in serum to identify ovarian cancer. Lancet 2002, 359, 572-577.
    • (2002) Lancet , vol.359 , pp. 572-577
    • Petricoin, E.F.1    Ardekani, A.M.2    Hitt, B.A.3    Levine, P.J.4
  • 15
    • 0142027764 scopus 로고    scopus 로고
    • Identification of biomarkers for ovarian cancer using strong anion-exchange ProteinChips: Potential use in diagnosis and prognosis
    • Kozak, K. R., Amneus, M. W., Pusey, S. M., Su, F. et al., Identification of biomarkers for ovarian cancer using strong anion-exchange ProteinChips: Potential use in diagnosis and prognosis. Proc. Natl. Acad. Sci. USA 2003, 100, 12343-12348.
    • (2003) Proc. Natl. Acad. Sci. USA , vol.100 , pp. 12343-12348
    • Kozak, K.R.1    Amneus, M.W.2    Pusey, S.M.3    Su, F.4
  • 16
    • 1842559788 scopus 로고    scopus 로고
    • Comparing datasets from different experiments
    • Reproducibility of SELDI-TOF protein patterns in serum
    • Baggerly, K. A., Morris, J. S., Coombes, K. R., Reproducibility of SELDI-TOF protein patterns in serum: Comparing datasets from different experiments. Bioinformatics 2004, 20, 777-785.
    • (2004) Bioinformatics , vol.20 , pp. 777-785
    • Baggerly, K.A.1    Morris, J.S.2    Coombes, K.R.3
  • 17
    • 1542378202 scopus 로고    scopus 로고
    • Analysis of serum proteomic patterns for early cancer diagnosis: Drawing attention to potential problems
    • Diamandis, E. P., Analysis of serum proteomic patterns for early cancer diagnosis: Drawing attention to potential problems. J. Natl. Cancer. Inst. 2004, 96, 353-356.
    • (2004) J. Natl. Cancer. Inst , vol.96 , pp. 353-356
    • Diamandis, E.P.1
  • 18
    • 1142291302 scopus 로고    scopus 로고
    • Biomarker amplification by serum carrier protein binding
    • Mehta, A. I., Ross, S., Lowenthal, M. S., Fusaro, V. et al., Biomarker amplification by serum carrier protein binding. Dis. Markers 2003, 19, 1-10.
    • (2003) Dis. Markers , vol.19 , pp. 1-10
    • Mehta, A.I.1    Ross, S.2    Lowenthal, M.S.3    Fusaro, V.4
  • 19
    • 19944419092 scopus 로고    scopus 로고
    • Evaluation of serum protein profiling by surface-enhanced laser desorption/ionization time-of-flight mass spectrometry for the detection of prostate cancer: I. Assessment of platform reproducibility
    • Semmes, O. J., Feng, Z., Adam, B. L., Banez, L. L. et al., Evaluation of serum protein profiling by surface-enhanced laser desorption/ionization time-of-flight mass spectrometry for the detection of prostate cancer: I. Assessment of platform reproducibility. Clin. Chem. 2005, 51, 102-112.
    • (2005) Clin. Chem , vol.51 , pp. 102-112
    • Semmes, O.J.1    Feng, Z.2    Adam, B.L.3    Banez, L.L.4
  • 20
    • 34548589093 scopus 로고    scopus 로고
    • Serum proteomic analysis identifies a highly sensitive and specific discriminatory pattern in stage 1 breast cancer
    • Belluco, C., Petricoin, E. F., Mammano, E., Facchiano, F. et al., Serum proteomic analysis identifies a highly sensitive and specific discriminatory pattern in stage 1 breast cancer. Ann. Surg. Oncol. 2007 9, 2470-2476.
    • (2007) Ann. Surg. Oncol , vol.9 , pp. 2470-2476
    • Belluco, C.1    Petricoin, E.F.2    Mammano, E.3    Facchiano, F.4
  • 21
    • 38749109634 scopus 로고    scopus 로고
    • Analytical validation of serum proteomic profiling for diagnosis of prostate cancer: Sources of sample bias
    • McLerran, D., Grizzle, W. E., Feng, Z., Bigbee, W. L. et al., Analytical validation of serum proteomic profiling for diagnosis of prostate cancer: Sources of sample bias. Clin. Chem. 2008, 54, 44-52.
    • (2008) Clin. Chem , vol.54 , pp. 44-52
    • McLerran, D.1    Grizzle, W.E.2    Feng, Z.3    Bigbee, W.L.4
  • 22
    • 38749151898 scopus 로고    scopus 로고
    • SELDI-TOF MS whole serum proteomic profiling with IMAC surface does not reliably detect prostate cancer
    • McLerran, D., Grizzle, W. E., Feng, Z., Thompson, I. M. et al., SELDI-TOF MS whole serum proteomic profiling with IMAC surface does not reliably detect prostate cancer. Clin. Chem. 2008, 54, 53-60.
    • (2008) Clin. Chem , vol.54 , pp. 53-60
    • McLerran, D.1    Grizzle, W.E.2    Feng, Z.3    Thompson, I.M.4
  • 23
    • 38749086467 scopus 로고    scopus 로고
    • Preanalytical influences in clinical proteomic studies: Raising awareness of fundamental issues in sample banking
    • Banks, R. E., Preanalytical influences in clinical proteomic studies: Raising awareness of fundamental issues in sample banking. Clin. Chem. 2008, 54, 6-7.
    • (2008) Clin. Chem , vol.54 , pp. 6-7
    • Banks, R.E.1
  • 25
    • 38749107769 scopus 로고    scopus 로고
    • Putting the "bio" back into biomarkers: Orienting proteomic discovery toward biology and away from the measurement platform
    • Liotta, L. A., Petricoin, E. F., Putting the "bio" back into biomarkers: Orienting proteomic discovery toward biology and away from the measurement platform. Clin. Chem. 2008, 54, 3-5.
    • (2008) Clin. Chem , vol.54 , pp. 3-5
    • Liotta, L.A.1    Petricoin, E.F.2
  • 26
    • 11144297955 scopus 로고    scopus 로고
    • Can mass spectrometric protein profiling meet desired standards of clinical laboratory practice?
    • Hortin, G. L., Can mass spectrometric protein profiling meet desired standards of clinical laboratory practice? Clin. Chem. 2005, 51, 3-5.
    • (2005) Clin. Chem , vol.51 , pp. 3-5
    • Hortin, G.L.1
  • 27
    • 27644528185 scopus 로고    scopus 로고
    • Cross-platform comparability of microarray technology: Intra-platform consistency and appropriate data analysis procedures are essential
    • Shi, L., Tong, W., Fang, H., Scherf, U. et al., Cross-platform comparability of microarray technology: Intra-platform consistency and appropriate data analysis procedures are essential. BMC Bioinformatics 2005, 6, S12.
    • (2005) BMC Bioinformatics , vol.6
    • Shi, L.1    Tong, W.2    Fang, H.3    Scherf, U.4
  • 28
    • 34347342575 scopus 로고    scopus 로고
    • QA/QC issues to aid regulatory acceptance of microarray gene expression data
    • Fuscoe, J. C., Tong, W., Shi, L., QA/QC issues to aid regulatory acceptance of microarray gene expression data. Environ. Mol. Mutagen. 2007, 48, 349-353.
    • (2007) Environ. Mol. Mutagen , vol.48 , pp. 349-353
    • Fuscoe, J.C.1    Tong, W.2    Shi, L.3
  • 29
    • 14644437012 scopus 로고    scopus 로고
    • Food and Drug Administration regulation of in vitro diagnostic devices
    • Mansfield, E., O'Leary, T. J., Gutman, S. I., Food and Drug Administration regulation of in vitro diagnostic devices. J. Mol. Diagn. 2005, 7, 2-7.
    • (2005) J. Mol. Diagn , vol.7 , pp. 2-7
    • Mansfield, E.1    O'Leary, T.J.2    Gutman, S.I.3
  • 30
    • 23944492885 scopus 로고    scopus 로고
    • Introduction to the Food and Drug Administration (FDA) regulatory process
    • Hackett, J. L., Gutman, S. I., Introduction to the Food and Drug Administration (FDA) regulatory process. J. Proteome Res. 2005, 4, 1110-1113.
    • (2005) J. Proteome Res , vol.4 , pp. 1110-1113
    • Hackett, J.L.1    Gutman, S.I.2
  • 31
    • 35748982917 scopus 로고    scopus 로고
    • The FDA's Critical Path Initiative for Medical Products
    • Aziz, K. J., The FDA's Critical Path Initiative for Medical Products. J. Clin. Ligand Assay 2006, 29, 171-176.
    • (2006) J. Clin. Ligand Assay , vol.29 , pp. 171-176
    • Aziz, K.J.1
  • 32
    • 0347235553 scopus 로고    scopus 로고
    • Roche's microarray tests US FDA's diagnostic policy
    • Kling, J., Roche's microarray tests US FDA's diagnostic policy. Nat. Biotechnol. 2003, 21, 959-960.
    • (2003) Nat. Biotechnol , vol.21 , pp. 959-960
    • Kling, J.1
  • 33
    • 18244409687 scopus 로고    scopus 로고
    • Gene expression profiling predicts clinical outcome of breast cancer
    • van't Veer, L. J., Dai, H., van de Vijver, M. J., He, Y. D. et al., Gene expression profiling predicts clinical outcome of breast cancer. Nature 2002, 415, 530-536.
    • (2002) Nature , vol.415 , pp. 530-536
    • van't Veer, L.J.1    Dai, H.2    van de Vijver, M.J.3    He, Y.D.4
  • 34
    • 33751193656 scopus 로고    scopus 로고
    • Converting a breast cancer microarray signature into a high-throughput diagnostic test
    • Glas, A. M., Floore, A., Delahaye, L. J., Witteveen, A. T. et al., Converting a breast cancer microarray signature into a high-throughput diagnostic test. BMC Genom. 2006, 7, 278.
    • (2006) BMC Genom , vol.7 , pp. 278
    • Glas, A.M.1    Floore, A.2    Delahaye, L.J.3    Witteveen, A.T.4
  • 35
    • 41049111199 scopus 로고    scopus 로고
    • Systematic review: Gene expression profiling assays in early-stage breast cancer
    • Marchionni, L., Wilson, R. F., Wolff, A. C., Marinopoulos, S. et al., Systematic review: Gene expression profiling assays in early-stage breast cancer. Ann. Intern. Med. 2008, 148, 358-369.
    • (2008) Ann. Intern. Med , vol.148 , pp. 358-369
    • Marchionni, L.1    Wilson, R.F.2    Wolff, A.C.3    Marinopoulos, S.4
  • 36
    • 36849069347 scopus 로고    scopus 로고
    • update of recommendations for the use of tumor markers in breast cancer
    • American Society of Clinical Oncology
    • Harris, L., Fritsche, H., Mennel, R., Norton, L. et al., American Society of Clinical Oncology 2007 update of recommendations for the use of tumor markers in breast cancer. J. Clin. Oncol. 2007, 25, 5287-5312.
    • (2007) J. Clin. Oncol , vol.2007 , Issue.25 , pp. 5287-5312
    • Harris, L.1    Fritsche, H.2    Mennel, R.3    Norton, L.4


* 이 정보는 Elsevier사의 SCOPUS DB에서 KISTI가 분석하여 추출한 것입니다.