Diagnostic Utility of Thyroseq as a Thyroid Molecular Test

👉The primary application of ThyroSeq is to provide accurate cancer diagnosis in thyroid nodules with indeterminate FNA cytology. 

👉Indeterminate FNA cytology encompasses diagnostic categories III, IV, and V of the Bethesda System for Reporting Thyroid Cytopathology.

👉Uncertain and variable risk of cancer in these nodules hampers clinical management of these patients. 

👉ThyroSeq stratifies thyroid nodules with indeterminate cytology into those that are most likely benign and can frequently be followed by observation and those that have a high probability of being cancer or pre-cancer, which in most cases need surgical management. 

👉ThyroSeq Clinical Validation Study Overview

  • Reported in the premiere medical journal – JAMA Oncology (Steward, DL et al. JAMA Oncol. 2018.) 
  • Largest prospective double-blind multicenter study of any commercially available molecular test
  • Highest NPV (97%) and PPV (66%) among well validated tests
  • Highest reduction in diagnostic surgery – allowing avoidance of surgery for up to 61% of all Bethesda III/IV nodules and 82% of indeterminate nodules with benign pathology 
  • Reliable detection of all types of thyroid tumors including Hurthle cell cancer
  • Reports probability of cancer and predicted risk of cancer recurrence, empowering individualized patient management