Development and Validation of NGS-based Clinical Cancer Panels for Precision medicine in Asian and Causasian Adult Cancers
Winston Patrick Kuo,
President,
Predicine Holdings Ltd; Founder and Editor in Chief, Journal of Circulating Biomarkers
In the new era of precision medicine, comprehensive cancer panels are needed to identify actionable cancer genes and match patients to personalized therapies. Here, we report a PanCancer NGS Panel designed by leaders in the field that comprises of all exon coding and selected hotspots of critical cancer genes in the most common cancer types for both Asian and Caucasian cohorts, including but not limited to lung, colon, breast and prostate cancer. The panel allows detection of known and novel variants in indicationspecific signaling pathways, disease biology, DNA repair, and in particular drug resistance, to advance research into personalized cancer treatment and for use in clinical trials to help the development of new targeted therapies. Technical validation was performed to characterize point mutations, indels, copy number variations and fusions across clinically relevant, actionable cancer genes in both liquid biopsies and formalinfixed paraffinembedded (FFPE) clinical specimens. Assay sensitivity, specificity and accuracy were tested using reference samples with known genetic profiling and further validated on a variety of orthogonal platforms such as digital PCR, allelespecific PCR and Sanger sequencing. To the best of our knowledge, this is the first ethnicspecific NGS diagnostic test designed specifically for Asian and Caucasian adult cancer patients.
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