Real-World Performance of the Afirma Genomic Sequencing Classifier (GSC)—A Meta-analysis
| العنوان: | Real-World Performance of the Afirma Genomic Sequencing Classifier (GSC)—A Meta-analysis |
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| المؤلفون: | Christian E Nasr, Massimiliano Andrioli, Mayumi Endo, R Mack Harrell, Masha J Livhits, Ibitoro Osakwe, Preethi Polavarapu, Allan Siperstein, Shuanzeng Wei, Xingyu Zheng, Ruochen Jiang, Yangyang Hao, J I ng Huang, Joshua P Klopper, Richard T Kloos, Giulia Kennedy, Trevor E Angell |
| المصدر: | The Journal of Clinical Endocrinology & Metabolism. 108:1526-1532 |
| بيانات النشر: | The Endocrine Society, 2022. |
| سنة النشر: | 2022 |
| مصطلحات موضوعية: | Endocrinology, Endocrinology, Diabetes and Metabolism, Biochemistry (medical), Clinical Biochemistry, Biochemistry |
| الوصف: | Context The 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. Objective This study's objective is to compare the RW GSC performance to the VS metrics. Methods Rules 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. Results In 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). Conclusion RW 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. |
| تدمد: | 1945-7197 0021-972X |
| URL الوصول: | https://explore.openaire.eu/search/publication?articleId=doi_dedup___::f6ac5ac92d72edfc6b078c21e006d9c0 https://doi.org/10.1210/clinem/dgac688 |
| حقوق: | OPEN |
| رقم الأكسشن: | edsair.doi.dedup.....f6ac5ac92d72edfc6b078c21e006d9c0 |
| قاعدة البيانات: | OpenAIRE |
| تدمد: | 19457197 0021972X |
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