Clinical sequencing using a next-generation sequencing-based multiplex gene assay in patients with advanced solid...

Area of Science:

• Oncology
• Genomics
• Clinical Diagnostics

Background:

• Next-generation sequencing (NGS) advances enable simultaneous genomic alteration testing in clinical practice.
• Multiplex gene assays offer comprehensive genomic profiling for various cancers.

Purpose of the Study:

• To evaluate the feasibility and utility of an NGS-based multiplex gene assay (OncoPrime) in clinical settings.
• To identify actionable genomic mutations in patients with solid tumors, including rare and refractory cases.

Main Methods:

• Clinical sequencing using the OncoPrime assay, covering 215 cancer-related genes and 17 rearranged genes.
• Testing was performed on 85 patients with solid tumors between April 2015 and July 2016.

Main Results:

• Successful sequencing was achieved in 94.1% of patients (80/85).
• Potentially actionable mutations were identified in 86.3% of sequenced patients (69/80), with TP53, KRAS, and APC being the most common.
• Nine patients (13.0%) received therapy guided by NGS results.

Conclusions:

• NGS-based multiplex gene assays are feasible for clinical implementation, identifying actionable mutations in a high percentage of patients.
• Integrating genomic information into therapeutic decision-making remains a key challenge for precision oncology.