Multicenter Clinical Experience With the Afirma Gene Expression Classifier

Alexander, Erik K.; Schorr, Melanie; Klopper, Joshua; Kim, Caroline; Sipos, Jennifer A.; Nabhan, Fadi; Parker, Christine; Steward, David L.; Mandel, Susan J.; Haugen, Bryan R.

doi:10.1210/jc.2013-2482

Cited by 207 publications

(205 citation statements)

References 16 publications

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“…The reported PPVs range from 14% to 57% in various studies, which largely limits its clinical utility to predict the risk of malignancy. [14][15][16][17] As pointed out by Marti et al, 14 the risk of malignancy really depends on each individual institution's prevalence of malignancy. Hürthle cell-rich lesions appear to represent another limitation to the Afirma GEC test.…”

Section: Afirma Gene Expression Classifiermentioning

confidence: 99%

“…22 On the other hand, 82% of patients with Afirma GEC suspicious result underwent surgery, compared with only 6% of those with Afirma GEC benign result. 17 ThyGenX TEST The identification of mutations in different types of thyroid carcinomas and the advances in the multiplexing analysis of cytology material allowed the development of genomic mutation-based tests. Gene mutations or translocation fusions associated with well-differentiated thyroid cancer have been extensively described previously.…”

Section: Afirma Gene Expression Classifiermentioning

confidence: 99%

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Molecular Testing of Thyroid Nodules: A Review of Current Available Tests for Fine-Needle Aspiration Specimens

Zhang

Lin²

2016

Archives of Pathology &Amp; Laboratory Medicine

100

158

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Context.— Fine-needle aspiration of thyroid nodules is a reliable diagnostic method to determine the nature of thyroid nodules. Nonetheless, indeterminate cytology diagnoses remain a diagnostic challenge. The development of multiplex molecular techniques and the identification of genetic alterations associated with different follicular cell–derived cancers in the thyroid have led to the introduction of several commercially available tests. Objective.— To summarize the most common commercially available molecular testing in thyroid cancer, focusing on the technical features and test performance validation. Data Sources.— Peer-reviewed original articles, review articles, and published conference abstracts were reviewed to analyze the advantages and limitations of the most common tests used in the evaluation of thyroid needle aspirations. Conclusions.— The most common tests available include the Afirma Gene Expression Classifier, ThyGenX, and ThyroSeq. The excellent negative predictive value (NPV) of the Afirma test allows it to be used as a “rule out” test. ThyGenX analyzes a panel of DNA mutations and RNA translocation fusion markers to assess the risk of malignancy with good NPV and positive predictive value. ThyroSeq is a next-generation sequencing–based gene mutation and fusion test that has been reported to have the best NPV and positive predictive value combined, suggesting that it can be used as a “rule in” and “rule out” test. Molecular testing of cytology specimens from thyroid nodules has the potential to play a major role in the evaluation of indeterminate thyroid lesions.

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Section: Afirma Gene Expression Classifiermentioning

confidence: 99%

Section: Afirma Gene Expression Classifiermentioning

confidence: 99%

Molecular Testing of Thyroid Nodules: A Review of Current Available Tests for Fine-Needle Aspiration Specimens

Zhang

Lin²

2016

Archives of Pathology &Amp; Laboratory Medicine

100

158

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“…It, therefore, seems reasonable to use GEA for FN/SFN cases and for AUS/ FLUS lesions diagnosed on repeat FNA materials. A recent multicenter analysis 35 of 339 cytologically indeterminate nodules with the Afirma GEC confirmed its substantial effect on clinical care recommendations.…”

Section: Gene Expression Analysismentioning

confidence: 87%

Value of Molecular Tests in Cytologically Indeterminate Lesions of Thyroid

Zhang

2015

Archives of Pathology &Amp; Laboratory Medicine

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Context Fine-needle aspiration has been the initial step in the workup of thyroid nodular lesions and has successfully reduced the number of unnecessary surgeries and improved preoperative malignancy detection. However, up to one-third of cases fall in the diagnostically “indeterminate group,” which poses a patient-management challenge. Objective To review the characteristics of molecular tests useful for stratifying the malignancy risk of indeterminate thyroid lesions, including their advantages and limitations. Data sources PubMed. Conclusions Molecular tests are useful for triage of indeterminate thyroid nodules initially diagnosed by using fine-needle aspiration. Immunocytochemistry is readily available with the shortest turnaround time among the molecular tests but suffers from poor reproducibility and low interpretation concordance. Gene mutation analysis is superior in detecting malignancies as a rule-in test, despite low specificity. Next-generation sequencing seems promising but needs more validations before widespread use. Gene expression profiling is more suitable for detecting benign lesions as a rule-out test to avoid unnecessary surgeries but is not reliable in excluding malignancies. MicroRNA profiling has great potential for both risk stratification and predicting prognosis but is limited by significant variations in sensitivity and specificity. Although many questions still need to be answered, taken together, molecular tests are a promising option for classifying cytologically indeterminate thyroid nodular lesions.

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“…This is true especially when thyroid FNA results turn out to be indeterminate. When a nodule is indeterminate by FNA, the optimal way is to repeat FNA or undergo molecular tests (Alexander, 2008;Nikiforov et al, 2009;Nikiforov et al, 2011;Alexander et al, 2012;Kim and Alexander, 2012;Zhou et al, 2012;Nikiforov et al, 2013;Ranjbari et al, 2013;Alexander et al, 2014). Surgery, however, should be regarded as the last resort if all the other options still fail to produce satisfactory results.…”

Section: Introductionmentioning

confidence: 99%

Annual Financial Impact of Thyroidectomies for Nodular Thyroid Disease in China

Liu

Zhu²,

Cui³

et al. 2014

Asian Pacific Journal of Cancer Prevention

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A large proportion of patients with thyroid nodules in China undergo thyroidectomy in order to get confirmatory histology diagnosis. The financial impact of this modality remains to be investigated. To evaluate rationality of performing thyroidectomy without a routine FNA preoperatively from the economic perspective, we conducted a retrospective, observational study of all archival thyroidectomies with records of cost per stay (CPS), cost per day (CPD) and length of stay (LOS) from 2008 to 2013 in the First Affiliated Hospital of Nanjing Medical University. We compared all the parameters between cancer and non-cancer thyroidectomies. We recruited 6, 140 thyroidectomies with valid records of CPS, CPD and LOS in this period. The CPS of cancer thyroidectomy was significantly higher than non-cancer thyroidectomy. The percentage of cancer thyroidectomy increased from 26.5% to 41.6%. The percentage of annual cost of cancer thyroidectomies rose from 30.2% to 45.2%. The LOS for cancer and non-cancer thyroidectomy decreased while the CPD increased in the past six years. The estimated national cost in 2012 for all thyroidectomies would be USD 1.86 billion with USD 1.09 billion for non-cancer thyroidectomies. We have witnessed great improvement in the healthcare for patients with thyroid nodules in China. However, given limited healthcare resources, currently thyroid FNA for more precise preoperative diagnosis may help to curb the rapidly increasing demand in healthcare costs in the future for nodular thyroid disease in China.

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Multicenter Clinical Experience With the Afirma Gene Expression Classifier

Cited by 207 publications

References 16 publications

Molecular Testing of Thyroid Nodules: A Review of Current Available Tests for Fine-Needle Aspiration Specimens

Molecular Testing of Thyroid Nodules: A Review of Current Available Tests for Fine-Needle Aspiration Specimens

Value of Molecular Tests in Cytologically Indeterminate Lesions of Thyroid

Annual Financial Impact of Thyroidectomies for Nodular Thyroid Disease in China

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