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Updated: Mar 24, 2026
Next Generation Sequencing for the Detection of Actionable Mutations in Solid and Liquid Tumors
Published on: September 20, 2016
[Companion Diagnostics for Solid Tumors]
Abstract:
Companion diagnostics (CoDx) will likely continue to rapidly increase in number and application to disease areas including solid tumors, for example EGFR for gefitinib and ALK fusion gene for crizotinib in non-small-cell lung cancer; KRAS against the use of cetuximab and panitumumab in colorectal cancer; HER2 for trastuzumab in breast cancer. CoDx are an indispensable part of personalized medicine and pharmacogenomics. In CoDx development, there are still many challenges, such as the business model promoting cooperation between diagnostics and pharmaceutical companies, and also the regulations related to CoDx. The FDA notice on the development of CoDx in 2011 recommended the co-development of a new drug and CoDx as the best practice, and the Ministry of Health, Labour and Welfare in Japan also issued a statement in 2013. In addition, the recent discovery of many novel variants in the DNA sequence, advances in sequencing and genomic technology, and improved analytic methods have enabled the impact of germline and somatic mutations to be determined using multiplex diagnosis. The complex challenges to develop CoDx necessitate a close collaboration among academic institutions, regulatory authorities, and pharmaceutical companies. [Review].
Insights
Companion diagnostics (CoDx) are vital for personalized medicine, enabling targeted therapies in oncology. Developing CoDx requires collaboration to overcome challenges in business models and regulations.
Area of Science:
- Oncology
- Pharmacogenomics
- Molecular Diagnostics
Background:
- Companion diagnostics (CoDx) are increasingly used in solid tumors, guiding targeted therapies like EGFR inhibitors in lung cancer and HER2-targeted treatments in breast cancer.
- CoDx are integral to personalized medicine and pharmacogenomics, linking specific genetic markers to drug efficacy.
- Examples include EGFR for gefitinib, ALK for crizotinib, KRAS for cetuximab/panitumumab, and HER2 for trastuzumab.
Purpose of the Study:
- To review the growing role and applications of companion diagnostics in oncology.
- To identify and discuss the challenges in companion diagnostic development, including business models and regulatory hurdles.
- To highlight the importance of collaboration among stakeholders for successful CoDx implementation.
Main Methods:
- Literature review of companion diagnostic applications and development trends.
- Analysis of regulatory recommendations and industry best practices.
- Discussion of technological advancements impacting CoDx, such as next-generation sequencing and multiplex diagnostics.
Main Results:
- Companion diagnostics are essential for precision medicine, with expanding applications in various cancers.
- Significant challenges persist in CoDx development, particularly concerning industry collaboration and regulatory frameworks.
- Advances in genomic technologies facilitate multiplex diagnosis for identifying germline and somatic mutations.
Conclusions:
- The development of companion diagnostics necessitates close collaboration between academic institutions, regulatory bodies, and pharmaceutical companies.
- Addressing business model and regulatory challenges is crucial for the continued growth and effective implementation of CoDx.
- Technological progress supports the expanding utility of CoDx in precision cancer care.
