Evidence map›Paper›PMID 41678360›Full record

ArticleThe Journal of clinical endocrinology and metabolism2026

Afirma genomic sequencing classifier performance in young patients with cytologically indeterminate thyroid nodules.

Luz E Castellanos, Julian Bryan, Julio C Ricarte-Filho, Aime T Franco, Mohammed Alshalalfa, Joshua P Klopper, Richard T Kloos, Steven G Waguespack

Abstract readValidation Study
In one paragraph

Article in The Journal of clinical endocrinology and metabolism, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

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.

2 · The registry

The trial behind it

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Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

2 citing papers in PubMed.

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4 · The record

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PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

8 authors.

Luz E CastellanosDepartment of Endocrine Neoplasia and Hormonal Disorders, The University of Texas MD Anderson Cancer Center, Houston, TX 77030, USA.ORCID 0000-0002-2171-7022
Julian BryanMolecular Diagnostics Laboratory, Division of Pathology and Laboratory Medicine, The University of Texas MD Anderson Cancer Center, Houston, TX 77030, USA.ORCID 0000-0003-1405-3667
Julio C Ricarte-FilhoDivision of Endocrinology and Diabetes, The Thyroid Center, Children's Hospital of Philadelphia, Philadelphia, PA 19104, USA.ORCID 0000-0002-8427-6869
Aime T FrancoDivision of Endocrinology and Diabetes, The Thyroid Center, Children's Hospital of Philadelphia, Philadelphia, PA 19104, USA.ORCID 0000-0002-1677-5228
Mohammed AlshalalfaVeracyte, Inc., South San Francisco, CA 94080, USA.
Joshua P KlopperVeracyte, Inc., South San Francisco, CA 94080, USA.ORCID 0000-0002-3172-7208
Richard T KloosVeracyte, Inc., South San Francisco, CA 94080, USA.ORCID 0000-0003-4183-7387
Steven G WaguespackDepartment of Endocrine Neoplasia and Hormonal Disorders, The University of Texas MD Anderson Cancer Center, Houston, TX 77030, USA.ORCID 0000-0003-0280-0100

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

contextThe Afirma Genomic Sequencing Classifier (GSC) is validated in patients ≥ 21 years with a 96% negative predictive value for malignancy when GSC-(B)enign. Afirma GSC has not been formally studied in patients <21 years of age with indeterminate thyroid nodules (ITNs).

objectiveTo evaluate Afirma GSC in young patients with ITNs.

designRetrospective analysis of Afirma GSC testing.

settingITNs referred for molecular testing in a real-world setting.

participantsForty-nine ITNs from 49 patients < 21 years of age who had histopathology or 2 years' clinical follow-up data ascertained.

interventionNone.

main outcome measureAfirma GSC test performance.

resultsIn 49 ITNs from patients aged 9 to 20 years (median 18.5 [interquartile range, 17.3-19.8]), 30 were GSC-B and 19 GSC-(S)uspicious, among which 14 (73.7%) were malignant (ie, true positive) and 5 (26.3%) were benign (ie, false positive). All 30 Afirma GSC-B cases were either histologically (n = 9) or clinically benign (n = 21) (ie, true negative). All 14 malignancies were GSC-S (sensitivity 100% [95% CI, 77-100]); 30/35 clinically or histologically benign cases were GSC-B (specificity 86% [95% CI, 70-95]). Negative predictive value for an Afirma GSC-B result was 100% [95% CI, 88-100]. Genomic alterations were not detected in the 30 GSC-B samples. Among the 14 malignant samples, there were 9 papillary thyroid carcinomas, 1 oncocytic carcinoma, 1 noninvasive follicular thyroid neoplasm with papillary-like nuclear features, and 3 follicular thyroid carcinomas.

conclusionIn young patients with ITNs, the Afirma GSC demonstrated an excellent negative predictive value when defining a thyroid nodule result by histology or clinical follow-up.

Indexed as

Pathology, MolecularThyroid NeoplasmsThyroid NoduleAdolescentBiopsy, Fine-NeedleChildFemaleGenetic TestingGenomicsHumansMalePredictive Value of TestsRetrospective StudiesYoung Adultbenignfusionmolecular diagnosticspediatricsuspiciousXpression atlas

Identifiers

PMID41678360
PMCPMC13271781

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LicenceCC BY-NC-ND
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Registered trials

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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.