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Analytical and clinical validation of a targeted-enhanced whole genome sequencing-based comprehensive genomic profiling test.

Ferguson, S.; Sriram, S.; Lee, J.; Wallace, J. K.; Kim, J.-A.; Lee, Y.; Oh, B. B.-L.; Lee, W. C.; Lee, S.; Connolly-Strong, E. C.

2023-12-18 genetic and genomic medicine
10.1101/2023.12.18.23300049 medRxiv
Show abstract

Evaluation of the test performance of the targeted enhanced whole-genome sequencing (TE-WGS) assay for comprehensive oncology genomic profiling. The analytical validation of the assay included sensitivity and specificity for single nucleotide variants (SNVs), insertions/deletions (indels), and structural variants (SVs), revealing a revealed a sensitivity of 99.8% for SNVs and 99.2% for indels. The PPV was 99.3% for SNVs and 98.7% for indels. Clinical validation was benchmarked against established orthogonal methods and demonstrated high concordance with reference methods in variant characterization. The TE-WGS assay enhances personalized cancer treatment by offering detailed genomic insights and the adaptability to include emerging biomarkers.

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