Overview
Early detection of cancer recurrence and treatment monitoring using non-invasive procedures such as circulating tumor DNA (ctDNA) profiling is an emerging new strategy for cancer patient care. ctDNA is shed by primary or metastatic tumor cells and contains tumor-specific somatic mutation signatures. However, most ctDNA-based molecular residual disease (MRD) detection methods leverage a limited genomic footprint, restricting detection sensitivity to 10-4 ~ 10-5 tumor fraction and thus their utility in many clinical settings 1, 2. In the post-diagnosis situation, early detection of cancer, especially those with low tumor mutational burden (TMB) 3, may become challenging if they do not harbor sufficient variants in these limited footprints to produce detectable signals. Further, insights into tumor evolution, including actionable mutations may be missed.
Here we report a performance update of the NeXT Personal® platform. NeXT Personal utilizes hybridization-capture-based technology to quantify ctDNA in liquid biopsy samples. Its unified probe panel design and workflow simultaneously detects and monitors MRD, surveys known cancer-related clinical variants, and quantifies and tracks investigational variants of interest, by leveraging both tumor-informed and tumor-agnostic genomic information (Fig. 1). The tumor-informed MRD content is dedicated to personalized MRD detection and longitudinal monitoring, which utilizes cumulative tumor-derived signals to achieve ultra-high sensitivity down to 1 ~ 3 parts per million (PPM) limit of detection (LOD). The tumor-agnostic clinically relevant content surveys known and validated actionable genomic variants in 90 clinically relevant genes, and serves to inform therapy selection and detect existing or potentially emerging events such as new subclones or metastases. The investigational content provides capacity to track important cancer-related variants for research or investigational purposes.
