Annals

Companion Diagnostics: From Biomarker Identification to Market Entry

Edited by Edited by Claudio Carini (Pfizer)
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Companion Diagnostics: From Biomarker Identification to Market Entry

Published: June 2015

Volume 1346

Discusses the development of biomarker-based companion diagnostics to optimize diagnosis and treatment choices.
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The recent growth in complex biological data has enabled a major paradigm shift in health care away from one-size-fits-all approaches toward customized, patient-tailored therapies. Biomarker-based companion diagnostics (CDx), designed to identify responsive patient subpopulations or those likely to experience adverse drug effects, lie at the heart of this personalized, precision medicine movement. The conference \"Companion Diagnostics: From Biomarker Identification to Market Entry,\" held on April 28–29, 2014, at the New York Academy of Sciences, brought together international scientists and clinicians from academia, industry, and government—as well as healthcare policy makers, regulatory experts, insurance sector representatives, and other stakeholders—to discuss research, financial, and regulatory strategies that will facilitate CDx development and integration into clinical care. This Annals volume presents a collection of papers stemming from this conference and covering a range of topics, including functional proteomic biomarkers in cancer; development of maraviroc, a CCR5 antagonist for treatment of HIV, using a novel tropism assay; biomarkers for precision medicine in airways disease; mTOR activation as a biomarker and a central pathway to autoimmune disorders, cancer, obesity, and aging; current opportunities and future prospects for personalized medicine in diabetes mellitus; innovation in metabolomics to improve personalized health care; some imminent but overlooked preanalytical and analytical challenges currently facing biomarkers and CDx; new indications for immunoassay-based CDx in oncology; and making personalized medicine more affordable.