Current Status of Companion and Complementary Diagnostics: Strategic Considerations for Development and Launch

US Food and Drug Administration (FDA)‐approved diagnostic assays play an increasingly common role in managing patients to prolong lifespan while also enhancing quality of life. Diagnostic assays can be essential for the safe and effective use of therapeutics (companion diagnostic), or may inform on...

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Autores principales: Scheerens, H, Malong, A, Bassett, K, Boyd, Z, Gupta, V, Harris, J, Mesick, C, Simnett, S, Stevens, H, Gilbert, H, Risser, P, Kalamegham, R, Jordan, J, Engel, J, Chen, S, Essioux, L, Williams, JA
Formato: Online Artículo Texto
Lenguaje:English
Publicado: John Wiley and Sons Inc. 2017
Materias:
Research
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5355969/
https://www.ncbi.nlm.nih.gov/pubmed/28121072
http://dx.doi.org/10.1111/cts.12455
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author Scheerens, H
Malong, A
Bassett, K
Boyd, Z
Gupta, V
Harris, J
Mesick, C
Simnett, S
Stevens, H
Gilbert, H
Risser, P
Kalamegham, R
Jordan, J
Engel, J
Chen, S
Essioux, L
Williams, JA
author_facet Scheerens, H
Malong, A
Bassett, K
Boyd, Z
Gupta, V
Harris, J
Mesick, C
Simnett, S
Stevens, H
Gilbert, H
Risser, P
Kalamegham, R
Jordan, J
Engel, J
Chen, S
Essioux, L
Williams, JA
author_sort Scheerens, H
collection PubMed
description US Food and Drug Administration (FDA)‐approved diagnostic assays play an increasingly common role in managing patients to prolong lifespan while also enhancing quality of life. Diagnostic assays can be essential for the safe and effective use of therapeutics (companion diagnostic), or may inform on improving the benefit/risk ratio without restricting drug access (complementary diagnostic). This tutorial reviews strategic considerations for drug and assay development resulting in FDA‐approved companion or complementary diagnostic status.
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spelling pubmed-53559692017-05-23 Current Status of Companion and Complementary Diagnostics: Strategic Considerations for Development and Launch Scheerens, H Malong, A Bassett, K Boyd, Z Gupta, V Harris, J Mesick, C Simnett, S Stevens, H Gilbert, H Risser, P Kalamegham, R Jordan, J Engel, J Chen, S Essioux, L Williams, JA Clin Transl Sci Research US Food and Drug Administration (FDA)‐approved diagnostic assays play an increasingly common role in managing patients to prolong lifespan while also enhancing quality of life. Diagnostic assays can be essential for the safe and effective use of therapeutics (companion diagnostic), or may inform on improving the benefit/risk ratio without restricting drug access (complementary diagnostic). This tutorial reviews strategic considerations for drug and assay development resulting in FDA‐approved companion or complementary diagnostic status. John Wiley and Sons Inc. 2017-02-27 2017-03 /pmc/articles/PMC5355969/ /pubmed/28121072 http://dx.doi.org/10.1111/cts.12455 Text en © 2017 The Authors. Clinical and Translational Science published by Wiley Periodicals, Inc. on behalf of American Society for Clinical Pharmacology and Therapeutics This is an open access article under the terms of the Creative Commons Attribution‐NonCommercial (http://creativecommons.org/licenses/by-nc/4.0/) License, which permits use, distribution and reproduction in any medium, provided the original work is properly cited and is not used for commercial purposes.
spellingShingle Research
Scheerens, H
Malong, A
Bassett, K
Boyd, Z
Gupta, V
Harris, J
Mesick, C
Simnett, S
Stevens, H
Gilbert, H
Risser, P
Kalamegham, R
Jordan, J
Engel, J
Chen, S
Essioux, L
Williams, JA
Current Status of Companion and Complementary Diagnostics: Strategic Considerations for Development and Launch
title Current Status of Companion and Complementary Diagnostics: Strategic Considerations for Development and Launch
title_full Current Status of Companion and Complementary Diagnostics: Strategic Considerations for Development and Launch
title_fullStr Current Status of Companion and Complementary Diagnostics: Strategic Considerations for Development and Launch
title_full_unstemmed Current Status of Companion and Complementary Diagnostics: Strategic Considerations for Development and Launch
title_short Current Status of Companion and Complementary Diagnostics: Strategic Considerations for Development and Launch
title_sort current status of companion and complementary diagnostics: strategic considerations for development and launch
topic Research
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5355969/
https://www.ncbi.nlm.nih.gov/pubmed/28121072
http://dx.doi.org/10.1111/cts.12455
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