Table 9. Concordance of FoundationOne Liquid CDx and an externally validated cfDNA NGS assay for select clinically actionable alterations (a subset of the results in Table 8).
Alteration | n | PPA (95% CI) | NPA (95% CI) |
---|---|---|---|
EGFR L858R | 10 | 100% (69.2%, 100.0%) | 100% (98.7%, 100.0%) |
EGFR Exon 19 non-frameshift deletions | 11 | 100% (71.5%, 100.0%) | 100% (99.7%, 100.0%) |
PIK3CA base substitutions | 49 | 100% (92.7%, 100.0%) | 100% (99.9%, 100.0%) |
ALK rearrangements | 1 | 100% (2.5%, 100.0%) | 99.9% (99.7%, 100.0%) |
NTRK1 rearrangements | 3 | 100% (29.2%, 100.0%) | 100% (99.8%, 100.0%) |
ROS1 rearrangements | 1 | 100% (2.5%, 100.0%) | 100% (99.8%, 100.0%) |
BRCA1 short variants | 1 | 100% (2.5%, 100.0%) | 100% (98.7%, 100.0%) |
BRCA2 short variants | 2 | 100% (15.8%, 100.0%) | 100% (99.3%, 100.0%) |
cfDNA = cell-free DNA; CI = confidence interval; NGS = next-generation sequencing; NPA = negative percent agreement; PPA = positive percent agreement; Ref = reference assay