Overcome
Diagnostic Uncertainty

Multicenter, retrospective, blinded validation study of 309 subjects with indeterminate thyroid nodules (Bethesda III, IV, or V) and corresponding surgical histology. Gold-standard unanimous consensus histopathology diagnosis (n=197) among three pathologists was used, and all molecular testing was performed using archived cytology smears. Results were reported in 3 categories (negative, moderate, or positive) based on the combined test results from both ThyGeNEXT^® (mutation panel) and ThyraMIR^® (microRNA risk classifier). The proportion of benign and malignant histopathologic subtypes within this study vastly differed from those found within a recent prospective study.^1,3 Histopathologic subtype prevalence adjustments were used to determine the impact of these differences on test performance.⁴ The analysis showed that test performance was optimal after prevalence adjustments.

The 3-category microRNA and mutation panel combination test had a high PPV (positive predictive value) at 75% and high NPV (negative predictive value) at 97% (n=178) after prevalence adjustments.¹ Prevalence-unadjusted, PPV and NPV were 74% and 95%, respectively, for the 3-category approach.¹

microRNA classification further risk-stratified patients with weak driver mutations, including RAS, resulting in four out of five nodules being accurately ruled-in or ruled-out for disease.¹