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Multiplatform molecular test performance in indeterminate thyroid nodules.

Mark A Lupo1, Ann E Walts2, J Woody Sistrunk3

  • 1Thyroid & Endocrine Center of Florida, Sarasota, Florida, USA.

Diagnostic Cytopathology
|August 9, 2020
PubMed
Summary
This summary is machine-generated.

This study shows a multiplatform test (MPTX) accurately assesses indeterminate thyroid nodules, improving surgical decisions. The MPTX test helps rule out or in disease, reducing unnecessary surgeries for thyroid nodules.

Keywords:
indeterminate thyroid nodulesmalignancymolecular testoutcomes

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Area of Science:

  • Endocrinology
  • Oncology
  • Molecular Diagnostics

Background:

  • Indeterminate thyroid nodules on fine-needle aspiration (FNA) cytology affect approximately 25% of cases.
  • Accurate risk stratification of these indeterminate nodules is crucial to avoid unnecessary thyroid surgeries.

Purpose of the Study:

  • To evaluate the performance of a multiplatform test (MPTX) for risk stratification of indeterminate thyroid nodules.
  • To assess the utility of MPTX in guiding surgical decisions for patients with indeterminate thyroid nodules.

Main Methods:

  • A blinded, multicenter study validated the MPTX, which combines a mutation panel (ThyGeNEXT®) and a microRNA risk classifier (ThyraMIR®).
  • Test performance was assessed using consensus histopathology diagnosis from three pathologists.
  • MPTX categorizes results into negative, moderate, and positive for disease risk.

Main Results:

  • MPTX demonstrated 95% sensitivity and 90% specificity for disease in nodules with Bethesda III and IV cytology.
  • Negative MPTX results achieved a 97% negative predictive value, effectively ruling out disease.
  • Positive MPTX results showed a 75% positive predictive value for high-risk disease, while moderate results indicated a 39% disease rate, often linked to RAS mutations.

Conclusions:

  • MPTX provides valuable data for managing indeterminate thyroid nodules, informing surgical decisions.
  • Surgical decisions should consider MPTX results, especially in light of challenges posed by RAS or RAS-like mutations.