Companion diagnostics: The key to personalized medicine

Expert Review of Molecular Diagnostics

Volumn 15, Issue 2, 2015, Pages 153-156

  Jorgensen, Jan Trost ^a  

^a Dx Rx Institute   (Denmark)

Author keywords

companion diagnostics; oncology; personalized medicine; precision medicine; rheumatology

Indexed keywords

BIOLOGICAL MARKER; CERITINIB; CRIZOTINIB; EPIDERMAL GROWTH FACTOR RECEPTOR 2; TRASTUZUMAB;

BIOINFORMATICS; BREAST CANCER; CHRONIC DISEASE; COMPANION DIAGNOSTIC; DIAGNOSIS; DNA MICROARRAY; EARLY DIAGNOSIS; EARLY INTERVENTION; GENE EXPRESSION ASSAY; GENE ONTOLOGY; GENE OVEREXPRESSION; GENOMICS; HUMAN; JOINT DESTRUCTION; META ANALYSIS (TOPIC); MOLECULAR MEDICINE; NEXT GENERATION SEQUENCING; NON SMALL CELL LUNG CANCER; PATHOPHYSIOLOGY; PERSONALIZED MEDICINE; PHASE 1 CLINICAL TRIAL (TOPIC); PROTEOMICS; REVIEW; RHEUMATOID ARTHRITIS; SENSITIVITY AND SPECIFICITY; SYSTEMS BIOLOGY; ARTHRITIS, RHEUMATOID; DNA SEQUENCE; GENETICS; MOLECULAR DIAGNOSIS; MOLECULARLY TARGETED THERAPY; NEOPLASMS;

ARTHRITIS, RHEUMATOID; HUMANS; INDIVIDUALIZED MEDICINE; MOLECULAR DIAGNOSTIC TECHNIQUES; MOLECULAR TARGETED THERAPY; NEOPLASMS; SEQUENCE ANALYSIS, DNA;

EID: 84921382045     PISSN: 14737159     EISSN: 17448352     Source Type: Journal    
DOI: 10.1586/14737159.2015.1002470     Document Type: Review

References (26)

1. Spear BB, Heath-Chiozzi M, Huff J. Clinical application of pharmacogenetics. Trends Mol Med 2001;7:201-4
2. US FDA. Guidance for Industry and Food and Drug Administration Staff. In Vitro Companion Diagnostic Devices. Available from: http://www.fda.gov/downloads/.MedicalDevices/DeviceRegulationand Guidance/GuidanceDocuments/.UCM262327.pdf [Accessed 11 December, 2014]
3. Slamon DJ, Leyland-Jones B, Shak S, et al. Use of chemotherapy plus a monoclonal antibody against HER2 for metastatic breast cancer that overexpresses HER2. N Engl J Med 2001;344:783-92
4. Jørgensen JT, Winther H. The Development of the HercepTest- From Bench to Bedside. In: Jørgensen JT, Winther H, editors. Molecular diagnostics- The key driver of personalized cancer medicine. Pan Stanford Publishing, Singapore; 2010. p. 43-60
5. US FDA. List of Cleared or Approved Companion Diagnostic Devices (In Vitro and Imaging Tools). Available from: http://.www.fda.gov/MedicalDevices/.ProductsandMedicalProcedures/.InVitroDiagnostics/ucm301431.htm [Accessed 11 December 2014]
6. Kwak EL, Bang YJ, Camidge DR, et al. Anaplastic lymphoma kinase inhibition in non-small-cell lung cancer. N Engl J Med 2010;363:1693-703
7. Shaw AT, Kim DW, Mehra R, et al. Ceritinib in ALK-rearranged non-small-cell lung cancer. N Engl J Med 2014;370: 1189-97
8. Conde E, Taniere P, Lopez-Rios F. The ALK testing conundrum. Expert Rev Mol Diagn 2015;15(2):161-63
9. Jørgensen JT. Companion diagnostics in oncology- current status and future aspects. Oncology 2013;85:59-68
10. Hayes D. Lessons for tumor biomarker trials: vicious cycles, scientific method &developing guidelines. Expert Rev Mol Diagn 2015;15(2):165-69
11. Hayes DF, Allen J, Compton C, et al. Breaking a vicious cycle. Sci Transl Med 2013;5(196):196cm6
12. Olsen D and Jørgensen JT. Companion diagnostics for targeted cancer drugs- clinical and regulatory aspects. Front Oncol 2014;4:105
13. Shimazawa R, Ikeda M. International differences in companion diagnostic approvals: how are we able to manage the differences?. Expert Rev Mol Diagn 2015; 15(2):157-59
14. Gerlinger M, Rowan AJ, Horswell S, et al. Intratumor heterogeneity and branched evolution revealed by multiregion sequencing. N Engl J Med 2012;366: 883-92
15. Vogelstein B, Papadopoulos N, Velculesc VE, et al. Cancer Genome Landscapes. Science 2013;339:1546-58
16. Lin E, Chien J, Ong FS, Fan JB. Challenges and opportunities for next-generation sequencing in companion diagnostics. Expert Rev Mol Diagn 2015; 15(2):193-209
17. Issa AM, Chaudhari VS, Marchant GE. The value of multigene predictors of clinical outcome in breast cancer: an analysis of the evidence. Expert Rev Mol Diagn 2015; 15(2):277-86
18. Schwarzenbach H, Hoon DS, Pantel K. Cell-free nucleic acids as biomarkers in cancer patients. Nat Rev Cancer 2011;11: 426-37
19. Schwarzenbach H. The potential of circulating nucleic acids as components of companion diagnostics for predicting and monitoring chemotherapy response. Expert Rev Mol Diagn 2015;15(2):267-75
20. Caberlotto L, Lauria M. Systems biology meets omic technologies: novel approaches to biomarker discovery and companion diagnostic development. Expert Rev Mol Diagn 2015;15(2):255-65
21. Gibson DS, Bustard MJ, McGeough CM, et al. Current and future trends in biomarker discovery and development of companion diagnostics for arthritis. Expert Rev Mol Diagn 2015;15(2):219-34
22. Doble B, Tan M, Harris A, et al. Modeling companion diagnostics in economic evaluations of targeted oncology therapies: systematic review and methodological checklist. Expert Rev Mol Diagn 2015; 15(2):235-54
23. Poste G, Compton CC, Barker AD. The national biomarker development alliance: confronting the poor productivity of biomarker research and development. Expert Rev Mol Diagn 2015;15(2):211-18
24. US Food and Drug Administration. Ceritinib. 2014. Available from: http://.www.fda.gov/drugs/informationondrugs/.approveddrugs/ucm395386.htm
25. Chabner BA. Approval after phase I: ceritinib runs the three-minute mile. Oncologist 2014;19:577-58
26. Jørgensen JT. Are we approaching the post-blockbuster era?.- Pharmacodiagnostics and rational drug development. Expert Rev Mol Diagn 2008;8:689-95