Validation of a liquid biopsy assay with increased sensitivity for clinical comprehensive genomic profiling.

ABSTRACT: Recent advancements in precision oncology have affirmed the need for comprehensive genomic profiling (CGP) liquid biopsy assays with increased sensitivity, especially for detecting alterations in tumors which shed circulating tumor DNA (ctDNA) at low abundance. Such tests could address the limitations of tissue biopsies while simultaneously enhancing the detection of clinically actionable variants. This study included analytical and clinical validation studies of Northstar Select, a plasma-based, tumor-naive CGP assay covering 84 genes. The assay detects SNV/Indels, CNVs (gain and loss), fusions, and microsatellite instability (MSI-H). A retrospective analysis of 674 analytical patient samples collected during routine care in the United States, covering various solid tumor types, was condu

SUBMITTER: Bower XS 

PROVIDER: S-EPMC12447423 | biostudies-literature | 2025 Sep

REPOSITORIES: biostudies-literature