reported a statistically significant improvement in the BCR with the GSC (N 139) versus the GEC (N 481) (61.2% versus 41.6%) and a concomitant 45% relative reduction in surgery with application of the GSC compared with the GEC. These authors reported a 66% relative reduction of indeterminate nodules progressing to surgery with the GSC compared with the GEC, with the majority of the reduction occurring for Bethesda III nodules. retrospectively compared GEC-tested (N 343) and GSC-tested (N 164) Bethesda III/IV nodules and found a higher BCR (76.2% versus 48.1%, p < 0.001), specificity (94.3% versus 61.4%, p < 0.001), and PPV (60.0% versus 33.3%, p = 0.01) for the GSC compared with the GEC when considering all unresected GEC/GSC-benign nodules to be true negatives. Overall, the GSC had a higher BCR than the GEC (65.8% versus 47.9%, p < 0.001). retrospectively examined the BCR for indeterminate (Bethesda III/IV) nodules tested with the GEC (N 486) or the GSC (N 114) after it became clinically available.
Postvalidation studies have compared the performance of the GEC and GSC in observational settings. The overall improved specificity with an increased number of benign results (BCR) suggests an improved ability to triage nodules for clinical observation. Among this subgroup, sensitivity of the GSC was 88.9% and specificity was 58.8%, reflecting improved performance compared with the GEC’s specificity of 11.8% for this same group of nodules. Of the 191 samples, 26 (13.6%) were Hürthle cell neoplasms on histopathology. At a malignancy prevalence of 24% (Bethesda III/IV), NPV for the GSC was 96% and PPV was 47%. High sensitivity was maintained for the GSC at 91%, and specificity was improved from the GEC’s 48% to 68% for Bethesda III/IV samples.
41,56 Of the 210 Bethesda III/IV nodules included in the GEC study, 191 (91.0%) retained sufficient RNA for analysis with the GSC. The GSC was clinically validated in a blinded study using the same cohort of samples with a histopathologic reference standard prospectively collected for the GEC clinical validation study. Nikolaos Stathatos, in Surgery of the Thyroid and Parathyroid Glands (Third Edition), 2021 Clinical Validation
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