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. 2017 Mar;10(2):84-92.
doi: 10.1111/cts.12455. Epub 2017 Feb 27.

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

H Scheerens  1 , A Malong  1 , K Bassett  1 , Z Boyd  1 , V Gupta  1 , J Harris  1 , C Mesick  1 , S Simnett  1 , H Stevens  2 , H Gilbert  1 , P Risser  1 , R Kalamegham  1 , J Jordan  2 , J Engel  2 , S Chen  2 , L Essioux  3 , J A Williams  1
Affiliations

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

H Scheerens et al. Clin Transl Sci. 2017 Mar.

Abstract

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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Figures

Figure 1
Figure 1
Historical timeline of the first Companion and first Complementary Diagnostic assays in the United States.
Figure 2
Figure 2
Impact of companion and complementary diagnostic status on (a) use of diagnostic test and (b) use of drug in advanced NSCLC. Data from Flatiron Health database 31 July 2016.
Figure 3
Figure 3
Potential commercial strategies of evolving Complementary Diagnostics.
See this image and copyright information in PMC

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