Thyroid disease

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

Eur Thyroid JPublished Diagnostic accuracy study

Authors' conclusion

The mir-THYpe full molecular test supported 95.5% of clinical decisions when negative and 89.8% when positive, reducing surgery rates by 79.5%. Therefore, the integration of this microRNA-based classifier into clinical practice represents a valuable tool in managing indeterminate thyroid nodules, reducing unnecessary thyroidectomies, and conserving valuable healthcare resources.

Study context

Population
Patients with indeterminate thyroid nodules (Bethesda III/IV) on fine-needle aspiration biopsy (FNAB) cytologyanalysed
Participants
256 patients
Outcome
Real-world clinical utility and diagnostic performance of the microRNA-based molecular test
Methodological detailsexternal, independent, prospective, real-world, observational, non-interventional
  • External
  • Independent
  • Prospective
  • Real-world
  • Observational
  • Non-interventional

Performance

As reported in the abstract

Diagnostic performance of the miRNA test in Bethesda III/IV nodules

Sensitivity

83.0%

Specificity

83.5%

PPV

62.8%

NPV

93.6%

Further findings

Surgery by test result

Test positive for malignancy
90 patients
Test-positive who underwent surgery
79 (90%)
Test-negative nodules
158
Test-negative who underwent thyroidectomy
7 (4.4%)

Original publication

External validation of a microRNA thyroid classifier: a real-world prospective study. Eur Thyroid J. Published 8 December 2025. doi:10.1530/etj-25-0105

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