External validation of a microRNA thyroid classifier: a real-world prospective study.

Area of Science:

• Endocrinology
• Molecular Diagnostics
• Oncology

Background:

• Thyroid nodules are common, with many incidentally discovered and benign.
• Fine-needle aspiration biopsy (FNAB) is used for malignancy risk assessment.
• Cytology classifies about 30% of cases as indeterminate, necessitating further evaluation.

Purpose of the Study:

• To validate the real-world clinical utility of the mir-THYpe full microRNA test.
• To assess the test's performance in improving diagnostic accuracy for indeterminate thyroid nodules.
• To determine the test's effectiveness in reducing unnecessary surgeries.

Main Methods:

• Prospective, observational, non-interventional validation study.
• Analysis of 256 patients with indeterminate thyroid nodules (Bethesda III/IV).
• Evaluation of the mir-THYpe full molecular classifier's diagnostic performance.

Main Results:

• The test showed 83.0% sensitivity and 83.5% specificity.
• Positive predictive value was 62.8%, and negative predictive value was 93.6%.
• Surgery rates were reduced by 79.5% in the study cohort.

Conclusions:

• The mir-THYpe full molecular test supports clinical decisions, particularly when negative.
• Integration of this microRNA test aids in managing indeterminate thyroid nodules.
• The classifier reduces unnecessary thyroidectomies and conserves healthcare resources.