Diagnostic Performance of Afirma and Interpace Diagnostics Genetic Testing in Indeterminate Thyroid Nodules: A Single Center Study
Indeterminate thyroid nodules (ITN) represent 20–30% of biopsied nodules, with a 10–60% risk of malignancy. Molecular testing can stratify the risk of malignancy among ITNs, and subsequently reduce the need for unnecessary diagnostic surgery. We aimed to assess the performance of these molecular tes...
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| Format: | Article |
| Language: | English |
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MDPI AG
2023-03-01
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| Series: | Cancers |
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| Online Access: | https://www.mdpi.com/2072-6694/15/7/2098 |
| _version_ | 1797608243322683392 |
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| author | Emad Kandil Tyler A. Metz Peter P. Issa Mohamed Aboueisha Mahmoud Omar Abdallah S. Attia Bert Chabot Mohammad Hussein Krzysztof Moroz Mohamed Shama Eman Toraih |
| author_facet | Emad Kandil Tyler A. Metz Peter P. Issa Mohamed Aboueisha Mahmoud Omar Abdallah S. Attia Bert Chabot Mohammad Hussein Krzysztof Moroz Mohamed Shama Eman Toraih |
| author_sort | Emad Kandil |
| collection | DOAJ |
| description | Indeterminate thyroid nodules (ITN) represent 20–30% of biopsied nodules, with a 10–60% risk of malignancy. Molecular testing can stratify the risk of malignancy among ITNs, and subsequently reduce the need for unnecessary diagnostic surgery. We aimed to assess the performance of these molecular tests at a single institution. Patients with Bethesda III, IV, and V nodules with Afirma and Interpace Diagnostics genetic testing data from November 2013 to November 2021 were included. Three cohorts were formed, including GSC + XA, ThyGeNEXT + ThyraMIR, and GSC + GEC. Statistical analysis determined the sensitivity, specificity, positive predictive value (PPV), negative predictive value (NPV), diagnostic odds ratio (DOR), and accuracy of each type of testing. The PPV of nodules undergoing genetic testing by ThyGeNEXT + ThyraMIR (45.00%, 95%CI: 28.28–62.93%, <i>p</i> = 0.032) and GSC + XA (57.14%, 95%CI: 29.32–81.08%, <i>p</i> < 0.001) were superior to that of GEC + GSC (30.72%, 95%CI: 26.83–34.90%). The NPV was above 85% in all cohorts, suggesting overall suitable rule-out tests. The Afirma platform (GSC + XA) had the highest NPV at 96.97%. The overall accuracy for nodules undergoing ThyGeNEXT + ThyraMIR was 81.42% (95%CI: 73.01–88.11%, <i>p</i> < 0.001). A total of 230 patients underwent thyroidectomy, including less than 60% of each of the ThyGeNEXT + ThyraMIR and GSC + XA cohorts. Specifically, only 25% of patients in the GSC + XA cohort underwent surgery, considerably decreasing the rate of unnecessary surgical intervention. Sub-group analysis, including only patients with surgical pathology, found that PPV tended to be higher in the GSC + XA cohort, at 66.67% (95%CI: 37.28–87.06%), as compared to the ThyGeNEXT + ThyraMIR cohort, at 52.94% (95%CI: 35.25–69.92%). The Afirma genetic testing platform GSC + XA outperformed the other platforms with regards to both PPV and NPV and decreased the rate of surgery in patients with ITNs by 75%, significantly preventing unnecessary surgical intervention. |
| first_indexed | 2024-03-11T05:40:43Z |
| format | Article |
| id | doaj.art-53a4e47d89944421a96fa467ed1f47c5 |
| institution | Directory Open Access Journal |
| issn | 2072-6694 |
| language | English |
| last_indexed | 2024-03-11T05:40:43Z |
| publishDate | 2023-03-01 |
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| record_format | Article |
| series | Cancers |
| spelling | doaj.art-53a4e47d89944421a96fa467ed1f47c52023-11-17T16:26:08ZengMDPI AGCancers2072-66942023-03-01157209810.3390/cancers15072098Diagnostic Performance of Afirma and Interpace Diagnostics Genetic Testing in Indeterminate Thyroid Nodules: A Single Center StudyEmad Kandil0Tyler A. Metz1Peter P. Issa2Mohamed Aboueisha3Mahmoud Omar4Abdallah S. Attia5Bert Chabot6Mohammad Hussein7Krzysztof Moroz8Mohamed Shama9Eman Toraih10Department of Surgery, Tulane University School of Medicine, New Orleans, LA 70112, USATulane University School of Medicine, New Orleans, LA 70112, USASchool of Medicine, Louisiana State University Health Sciences Center, New Orleans, LA 70112, USADepartment of Surgery, Tulane University School of Medicine, New Orleans, LA 70112, USADepartment of Surgery, Tulane University School of Medicine, New Orleans, LA 70112, USADepartment of Surgery, Tulane University School of Medicine, New Orleans, LA 70112, USATulane University School of Medicine, New Orleans, LA 70112, USADepartment of Surgery, Tulane University School of Medicine, New Orleans, LA 70112, USADepartment of Pathology, Tulane University School of Medicine, New Orleans, LA 70112, USADepartment of Surgery, Tulane University School of Medicine, New Orleans, LA 70112, USADepartment of Surgery, Tulane University School of Medicine, New Orleans, LA 70112, USAIndeterminate thyroid nodules (ITN) represent 20–30% of biopsied nodules, with a 10–60% risk of malignancy. Molecular testing can stratify the risk of malignancy among ITNs, and subsequently reduce the need for unnecessary diagnostic surgery. We aimed to assess the performance of these molecular tests at a single institution. Patients with Bethesda III, IV, and V nodules with Afirma and Interpace Diagnostics genetic testing data from November 2013 to November 2021 were included. Three cohorts were formed, including GSC + XA, ThyGeNEXT + ThyraMIR, and GSC + GEC. Statistical analysis determined the sensitivity, specificity, positive predictive value (PPV), negative predictive value (NPV), diagnostic odds ratio (DOR), and accuracy of each type of testing. The PPV of nodules undergoing genetic testing by ThyGeNEXT + ThyraMIR (45.00%, 95%CI: 28.28–62.93%, <i>p</i> = 0.032) and GSC + XA (57.14%, 95%CI: 29.32–81.08%, <i>p</i> < 0.001) were superior to that of GEC + GSC (30.72%, 95%CI: 26.83–34.90%). The NPV was above 85% in all cohorts, suggesting overall suitable rule-out tests. The Afirma platform (GSC + XA) had the highest NPV at 96.97%. The overall accuracy for nodules undergoing ThyGeNEXT + ThyraMIR was 81.42% (95%CI: 73.01–88.11%, <i>p</i> < 0.001). A total of 230 patients underwent thyroidectomy, including less than 60% of each of the ThyGeNEXT + ThyraMIR and GSC + XA cohorts. Specifically, only 25% of patients in the GSC + XA cohort underwent surgery, considerably decreasing the rate of unnecessary surgical intervention. Sub-group analysis, including only patients with surgical pathology, found that PPV tended to be higher in the GSC + XA cohort, at 66.67% (95%CI: 37.28–87.06%), as compared to the ThyGeNEXT + ThyraMIR cohort, at 52.94% (95%CI: 35.25–69.92%). The Afirma genetic testing platform GSC + XA outperformed the other platforms with regards to both PPV and NPV and decreased the rate of surgery in patients with ITNs by 75%, significantly preventing unnecessary surgical intervention.https://www.mdpi.com/2072-6694/15/7/2098indeterminate thyroid nodulesAfirmaInterpace Diagnosticstatistical measuresgenetic testing |
| spellingShingle | Emad Kandil Tyler A. Metz Peter P. Issa Mohamed Aboueisha Mahmoud Omar Abdallah S. Attia Bert Chabot Mohammad Hussein Krzysztof Moroz Mohamed Shama Eman Toraih Diagnostic Performance of Afirma and Interpace Diagnostics Genetic Testing in Indeterminate Thyroid Nodules: A Single Center Study Cancers indeterminate thyroid nodules Afirma Interpace Diagnostic statistical measures genetic testing |
| title | Diagnostic Performance of Afirma and Interpace Diagnostics Genetic Testing in Indeterminate Thyroid Nodules: A Single Center Study |
| title_full | Diagnostic Performance of Afirma and Interpace Diagnostics Genetic Testing in Indeterminate Thyroid Nodules: A Single Center Study |
| title_fullStr | Diagnostic Performance of Afirma and Interpace Diagnostics Genetic Testing in Indeterminate Thyroid Nodules: A Single Center Study |
| title_full_unstemmed | Diagnostic Performance of Afirma and Interpace Diagnostics Genetic Testing in Indeterminate Thyroid Nodules: A Single Center Study |
| title_short | Diagnostic Performance of Afirma and Interpace Diagnostics Genetic Testing in Indeterminate Thyroid Nodules: A Single Center Study |
| title_sort | diagnostic performance of afirma and interpace diagnostics genetic testing in indeterminate thyroid nodules a single center study |
| topic | indeterminate thyroid nodules Afirma Interpace Diagnostic statistical measures genetic testing |
| url | https://www.mdpi.com/2072-6694/15/7/2098 |
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