Thyroid disease

Performance of Afirma Genomic Sequencing Classifier in Binary Subcategories of Atypia of Undetermined Significance Thyroid Nodules: Single Versus Repeat Diagnosis

ThyroidPublished Retrospective diagnostic accuracy study

Authors' conclusion

GSC BCR and diagnostic performance of GSC testing may vary in AUS-N versus AUS-O subcategories. However, there were no statistically significant differences in GSC performance between single and repeat AUS cohorts.

Study context

Population
Thyroid nodules with a single or repeat atypia of undetermined significance (AUS) diagnosis on fine-needle aspiration and a diagnostic Genomic Sequencing Classifier (GSC) result (benign vs suspicious), followed by surgery or ≥12 months of clinical and/or US monitoring
Participants
365 thyroid nodules
Comparison
GSC performance in AUS-N vs AUS-O, and single vs repeat AUS cohorts
  • AUS-Nn = 106
  • AUS-On = 259reference
Outcome
Performance of GSC testing in AUS-N vs AUS-O subcategories and between single and repeat AUS cohorts
Methodological detailsconsecutive nodules
  • Consecutive nodules

Performance

As reported in the abstract

GSC benign call rate (BCR)
  • AUS-N vs AUS-O: P = 0.001
  • AUS-N vs AUS-O: P = 0.02

Further findings

OutcomeP value
Histology-proven malignancy with suspicious GSC resultAUS-N vs AUS-O · single AUS: 28% vs 10%; tended to be greater with AUS-NP = 0.09
Histology-proven malignancy with suspicious GSC resultAUS-N vs AUS-O · repeat AUS: 38% vs 27%; tended to be greater with AUS-NP = 0.3
Specificity, single AUS cohort73% vs 51%; higher with AUS-OP = 0.01

Repeat vs single AUS cohort performance

In both subcategories, repeat AUS cohort had greater specificity, PPV and diagnostic accuracy than single AUS; differences not statistically significant

Original publication

Performance of Afirma Genomic Sequencing Classifier in Binary Subcategories of Atypia of Undetermined Significance Thyroid Nodules: Single Versus Repeat Diagnosis. Thyroid. Published 4 December 2024. doi:10.1089/thy.2024.0277

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