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A 10-Gene Classifier for Indeterminate Thyroid Nodules: Development and Multicenter Accuracy Study.

Hernán E González1, José R Martínez1, Sergio Vargas-Salas1

  • 11 Department of Surgical Oncology, Pontificia Universidad Católica de Chile , Santiago, Chile .

Thyroid : Official Journal of the American Thyroid Association
|May 20, 2017
PubMed
Summary
This summary is machine-generated.

A new gene classifier accurately identifies thyroid nodules from indeterminate cytology, offering a potential solution for local laboratory testing. This molecular test improves diagnostic accuracy and may reduce the need for unnecessary surgeries.

Keywords:
gene classifierin vitro diagnostic testindeterminate thyroid nodulesqPCR

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Area of Science:

  • Molecular Diagnostics
  • Oncology
  • Genetics

Background:

  • Diagnostic surgery is the primary method for indeterminate thyroid cytology globally.
  • Limited availability of molecular testing kits for local laboratories in the US.
  • Need for improved diagnostic tools for thyroid nodules.

Purpose of the Study:

  • Develop a prototype in vitro diagnostic (IVD) gene classifier.
  • Characterize thyroid nodules with indeterminate cytology.
  • Provide a solution for local laboratory testing.

Main Methods:

  • Quantitative polymerase chain reaction (qPCR) to assess 18-gene expression in 114 fresh-tissue biopsies.
  • Supervised machine learning to train and test classifiers on independent sample sets.
  • Development of a multiplexed-qPCR IVD prototype assay tested in a multicenter cohort.

Main Results:

  • A 10-gene classifier achieved 93% sensitivity and 81% specificity in tissue biopsies.
  • The IVD prototype demonstrated an area under the curve of 0.97 in fine-needle aspiration biopsies.
  • High negative predictive value (97-99%) expected for the IVD prototype.

Conclusions:

  • A novel multiplexed-qPCR IVD prototype accurately classifies thyroid nodules.
  • The assay shows promise for local reference laboratory testing.
  • Potential to improve thyroid nodule diagnosis and patient management.