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Research Letter
October 8, 2020

Association of Study Methods and Industry Sponsorship With Inconsistent Performance of Molecular Assays for Indeterminate Thyroid Nodules

Author Affiliations
  • 1Department of Surgery, Weill Cornell Medicine, New York, New York
  • 2Department of Surgery, Memorial Sloan Kettering Cancer Center, New York, New York
JAMA Otolaryngol Head Neck Surg. Published online October 8, 2020. doi:10.1001/jamaoto.2020.3252

A subset (15%-25%) of thyroid nodules undergoing biopsy cannot be classified as benign or malignant. Under the Bethesda System for Reporting Thyroid Cytopathology, these cytologically indeterminate thyroid nodules (ITNs) are categories III and IV.1 Molecular assays using genetic and/or gene expression data may help risk stratify ITNs, potentially guiding decisions to operate or observe. These assays include the Afirma Gene Expression Classifier and Genomic Sequencing Classifier (Veracyte), and ThyroSeq v2 and v3 (CBLPath). Afirma panels are marketed to rule out malignancy with high negative predictive value, and ThyroSeq panels are marketed as rule out/rule in tests with high negative predictive values (NPV) and positive predictive values (PPV).