SynthesisThe Journal of clinical endocrinology and metabolism2023
Real-World Performance of the Afirma Genomic Sequencing Classifier (GSC)-A Meta-analysis.
Synthesis in The Journal of clinical endocrinology and metabolism, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 19 papers, 2 of them syntheses that pooled it.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
19 citing papers in PubMed, 2 syntheses or guidelines pooled it.
- Global multi-ancestry genome-wide analyses identify genes and biological pathways associated with thyroid cancer and benign thyroid diseases.Nature genetics · 2026Pooled it
- Comparing the diagnostic accuracy of Afirma GSC to ThyroSeq V3 in cytologically indeterminate thyroid nodules.European thyroid journal · 2025Pooled it
- Molecular Diagnostics and [Thyroid : official journal of the American Thyroid Association · 2024Trial
- Bethesda III and IV Thyroid Nodules Managed Nonoperatively After Molecular Testing With Afirma GSC or Thyroseq v3.The Journal of clinical endocrinology and metabolism · 2023Trial
- The Diagnostic Performance of Afirma Genomic Sequencing Classifier in Black and Hispanic Patients With Indeterminate Thyroid Nodules.Otolaryngology--head and neck surgery : official journal of American Academy of Otolaryngology-Head and Neck Surgery · 2026Article
- National Trends in Thyroidectomy and Molecular Diagnostic Utilization: A Medicare Analysis (2016-2023).The Laryngoscope · 2026Article
- Article
- Afirma genomic sequencing classifier performance in young patients with cytologically indeterminate thyroid nodules.The Journal of clinical endocrinology and metabolism · 2026Article
- Precision medicine in thyroid nodules: current strategies, challenges, and future directions.Hormones (Athens, Greece) · 2026Review
- The actual and future role of molecular tests in thyroid pathology.Virchows Archiv : an international journal of pathology · 2026Review
- Small Multi-Gene DNA Panel Can Aid in Reducing the Surgical Resection Rate and Predicting the Malignancy Risk of Thyroid Nodules.Endocrinology and metabolism (Seoul, Korea) · 2024Article
- Precision Medicine in Cytopathology.Surgical pathology clinics · 2024Review
- Assessment of the risk of malignancy in Bethesda III thyroid nodules: a comprehensive review.Endocrine · 2024Review
- Two Rare Cases of Metastatic Occult Thyroid Carcinoma Without Primary Cancer in the Thyroid Gland.Cureus · 2024Article
- Current State of Molecular Cytology in Thyroid Nodules: Platforms and Their Diagnostic and Theranostic Utility.Journal of clinical medicine · 2024Review
- Artificial Intelligence in Thyroidology: A Narrative Review of the Current Applications, Associated Challenges, and Future Directions.Thyroid : official journal of the American Thyroid Association · 2023Review
- Molecular testing in indeterminate thyroid nodules: an additional tool for clinical decision-making.Pathologica · 2023Review
- Article
- Molecular diagnostics in the evaluation of thyroid nodules: Current use and prospective opportunities.Frontiers in endocrinology · 2023Review
Corrections and comments
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Authors and funding
17 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
contextThe Afirma® GSC aids in risk stratifying indeterminate thyroid nodule cytology (ITN). The 2018 GSC validation study (VS) reported a sensitivity (SN) of 91%, specificity (SP) of 68%, positive predictive value (PPV) of 47%, and negative predictive value (NPV) of 96%. Since then, 13 independent real-world (RW) postvalidation studies have been published.
objectiveThis study's objective is to compare the RW GSC performance to the VS metrics.
methodsRules and assumptions applying to this analysis include: (1) At least 1 patient with molecular benign results must have surgery for that study to be included in SN, SP, and NPV analyses. (2) Molecular benign results without surgical histology are considered true negatives (TN) (as are molecular benign results with benign surgical histology). (3) Unoperated patients with suspicious results are either excluded from analysis (observed PPV [oPPV] and observed SP [oSP]) or assumed histology negatives (false positives; conservative PPV [cPPV] and conservative SP [cSP]) 4. Noninvasive follicular thyroid neoplasm with papillary-like nuclear features is considered malignant.
resultsIn RW studies, the GSC demonstrates a SN, oSP, oPPV, and NPV of 97%, 88%, 65%, 99% respectively, and conservative RW performance showed cSP of 80% and cPPV of 49%, all significantly higher than the VS except for SN and cPPV. There was also a higher benign call rate (BCR) of 67% in RW studies compared to 54% in the VS (P < 0.05).
conclusionRW data for the Afirma GSC demonstrates significantly better oSP and oPPV performance than the VS, indicating an increased yield of cancers for resected GSC suspicious nodules. The higher BCR likely increases the overall rate of clinical observation in lieu of surgery.
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Registered trials
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