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Considerations of developing an NGS assay for clinical applications in precision oncology: The NCI-MATCH NGS assay
1Molecular Characterization and Clinical Assay Development Laboratory, Frederick National Laboratory for Cancer Research, Frederick, MD.
Abstract:
Next generation sequencing (NGS) technologies have been widely adapted in clinical oncology by utilizing the profiled genetic mutation information to select patients and to guide the choice of target therapy. To fulfill the regulatory compliance, development of an NGS assay that will be used in clinical trials requires an analytical validation to meet its intend clinical use. NCI-MATCH trial is the largest precision oncology basket trial which uses a single NGS assay (NCI-MATHC NGS assay) to screen the actionable mutations in 6000 patients, who have relapsed/refractory solid tumors and lymphomas after standard systemic treatment, and assigns matched treatment. This article reviews on the critical considerations during development and validation of NGS assays as an investigational device for genomic based clinical trials and provides the experiences from the development of NCI-MATCH NGS assay.
Insights
Developing and validating next-generation sequencing (NGS) assays for clinical trials is crucial for precision oncology. This review covers key considerations and experiences from the NCI-MATCH trial
Area of Science:
- Oncology
- Genomics
- Clinical Diagnostics
Background:
- Next-generation sequencing (NGS) is vital in clinical oncology for guiding targeted therapies based on genetic mutations.
- Analytical validation of NGS assays is essential for regulatory compliance in clinical trials.
Purpose of the Study:
- To review critical considerations for developing and validating NGS assays as investigational devices for genomic-based clinical trials.
- To share experiences from the development of the NCI-MATCH NGS assay.
Main Methods:
- Review of critical considerations in NGS assay development and validation.
- Case study of the NCI-MATCH NGS assay development.
Main Results:
- The NCI-MATCH trial utilizes a single NGS assay to screen actionable mutations in patients with relapsed/refractory solid tumors and lymphomas.
- Successful development and validation of an NGS assay are critical for patient selection and matched treatment assignment in large-scale precision oncology trials.
Conclusions:
- Rigorous analytical validation is paramount for NGS assays used in clinical trials to ensure reliable genomic profiling.
- The NCI-MATCH trial's experience highlights the importance of robust NGS assay development for advancing precision oncology.
