For the risk stratification of indeterminate thyroid nodules

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Insights on Real-world Data of Molecular Testing for Indeterminate Thyroid Nodules

At the United States and Canadian Academy of Pathology’s 115th Annual Meeting, Poster #14 presented new real-world data that demonstrated the effectiveness of the ThyGeNEXT® + ThyraMIR®v2 combination testing platform in helping guide appropriate management decisions—supporting either surveillance or surgery—for patients with indeterminate thyroid nodules.1

Study Overview

This retrospective study evaluated 334 consecutive patients in the Allegheny Health Network with indeterminate thyroid nodules and a cytology diagnosis of Atypia of Undetermined Significance (Bethesda-III; n=285) or Follicular Neoplasm (Bethesda-IV; n=49).1

All patients underwent molecular testing with ThyGeNEXT + ThyraMIRv2 (MPTXv2), a combined oncogene panel and microRNA classifier/pairwise expression profiler, to assess the estimated risk of malignancy (EROM).1-3

Key Findings

  • Of the 334 patients, 271 underwent surveillance; none required surgery during the clinical follow-up period (3.1 to 21 months)1
  • 73% of patients (244/334) received negative test results from both the oncogene panel and the microRNA pairwise expression profiler1
  • There was a strong correlation between the MPTXv2 estimated risk of malignancy (EROM) and the actual risk of malignancy (AROM)1
  • The MPTXv2 EROM played a significant role in guiding treatment decisions— the lower the EROM, the higher likelihood of surveillance rather than surgery1
  • The MPTXv2 EROM demonstrated high accuracy in distinguishing benign from malignant nodules, and was the strongest positive predictor for the AROM based upon those cases with surgical outcomes1

These findings reinforce the diagnostic accuracy of the ThyGeNEXT + ThyraMIRv2 combination testing platform in the risk stratification of indeterminate thyroid nodules and its impact on treatment decisions.1-3

By integrating mutational analysis with microRNA profiling, this multiplatform molecular test can provide confidence to help guide patient management decisions—resulting in fewer surgeries on benign nodules.1-3

Patient management decisions are based on the independent medical judgment of the physician and molecular test results should be taken into consideration in conjunction with all relevant imaging, clinical findings, patient and family history, as well as patient preference.

References: 1. Santosa S, et al. Real-World Study Highlighting the Effectiveness of a Multiplatform Molecular Test in Guiding Management Decisions for Thyroid Nodules with an Indeterminate Cytology Diagnosis. Poster presented at: United States and Canadian Academy of Pathology’s 115th Annual Meeting; March 25, 2026; San Antonio, Texas. 2. Finkelstein SD, et al. Thyroid. 2022;32(11):1362-1371. 3. Verma T, et al. Cancer Cytopathol. 2024;132(9):556-563.

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