Tanvi Verma MD, Cody Marshall DO, Kossivi E. Dantey MD, Diane V. Thompson MS, Anna Banizs MD, Sydney D. Finkelstein MD, Joseph DelTondo DO
{"title":"ThyGeNEXT癌基因检测小组与扩展miRNA检测小组ThyraMIRv2联合使用在不确定甲状腺结节中的作用：一项大型、盲法、真实世界观察研究。","authors":"Tanvi Verma MD, Cody Marshall DO, Kossivi E. Dantey MD, Diane V. Thompson MS, Anna Banizs MD, Sydney D. Finkelstein MD, Joseph DelTondo DO","doi":"10.1002/cncy.22829","DOIUrl":null,"url":null,"abstract":"<div>\n \n \n <section>\n \n <h3> Background</h3>\n \n <p>Molecular analysis of fine-needle aspiration biopsies (FNAB) improves the diagnostic accuracy of cytologically indeterminate thyroid nodules (ITNs). Recently, the use of MPTXv2 has been shown to further improve the accuracy of risk stratification of ITNs.</p>\n </section>\n \n <section>\n \n <h3> Methods</h3>\n \n <p>A total of 338 patient samples with atypia of undetermined significance (<i>n</i> = 258) or follicular neoplasm (<i>n</i> = 80) cytology diagnosis and corresponding surgical outcomes or clinical follow-up, collected between 2016 and 2020 were included [Correction added on 19 June 2024, after first online publication: In the preceding sentence, the <i>n</i> values 260 and 78 have been changed to 258 and 80, respectively.]. All samples underwent multiplatform testing (MPTXv1), which includes an oncogene panel (ThyGeNEXT<sup>®</sup>) plus a microRNA risk classifier (ThyraMIR<sup>®</sup>). A blinded, secondary analysis was performed to assess the added utility of MPTXv2 (ThyraMIR<sup>®</sup>v2). The average length of follow-up for the surveillance group (<i>n</i> = 248) was 30 months.</p>\n </section>\n \n <section>\n \n <h3> Results</h3>\n \n <p>Sensitivity at moderate threshold was 96% and specificity at positive threshold was 99% for MPTXv2. At 14% disease prevalence, the negative predictive value at the moderate threshold was 99% and the positive predictive value at the positive threshold was 89% for MPTXv2. MPTXv2 had fewer patients classified into the moderate-risk group than MPTXv1, which was statistically significant (<i>p</i> < .001). Using surgical resection, the gold standard for outcomes, MPTXv2 showed a statistically greater area under the curve (<i>p</i> = .028) than MPTXv1, demonstrating greater accuracy for MPTXv2.</p>\n </section>\n \n <section>\n \n <h3> Conclusion</h3>\n \n <p>Both test versions demonstrated robust performance with low false-positive molecular results. Data suggest that incorporation of MPTXv1, and more recently MPTXv2, into clinical practice within our healthcare network resulted in improved accuracy of ITN risk stratification.</p>\n </section>\n </div>","PeriodicalId":9410,"journal":{"name":"Cancer Cytopathology","volume":"132 9","pages":"556-563"},"PeriodicalIF":2.6000,"publicationDate":"2024-05-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://onlinelibrary.wiley.com/doi/epdf/10.1002/cncy.22829","citationCount":"0","resultStr":"{\"title\":\"The role of the ThyGeNEXT oncogene panel used in combination with the expanded miRNA panel ThyraMIRv2 in Indeterminate thyroid nodules: A large, blinded, real-world, observational study\",\"authors\":\"Tanvi Verma MD, Cody Marshall DO, Kossivi E. Dantey MD, Diane V. Thompson MS, Anna Banizs MD, Sydney D. Finkelstein MD, Joseph DelTondo DO\",\"doi\":\"10.1002/cncy.22829\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<div>\\n \\n \\n <section>\\n \\n <h3> Background</h3>\\n \\n <p>Molecular analysis of fine-needle aspiration biopsies (FNAB) improves the diagnostic accuracy of cytologically indeterminate thyroid nodules (ITNs). Recently, the use of MPTXv2 has been shown to further improve the accuracy of risk stratification of ITNs.</p>\\n </section>\\n \\n <section>\\n \\n <h3> Methods</h3>\\n \\n <p>A total of 338 patient samples with atypia of undetermined significance (<i>n</i> = 258) or follicular neoplasm (<i>n</i> = 80) cytology diagnosis and corresponding surgical outcomes or clinical follow-up, collected between 2016 and 2020 were included [Correction added on 19 June 2024, after first online publication: In the preceding sentence, the <i>n</i> values 260 and 78 have been changed to 258 and 80, respectively.]. All samples underwent multiplatform testing (MPTXv1), which includes an oncogene panel (ThyGeNEXT<sup>®</sup>) plus a microRNA risk classifier (ThyraMIR<sup>®</sup>). A blinded, secondary analysis was performed to assess the added utility of MPTXv2 (ThyraMIR<sup>®</sup>v2). The average length of follow-up for the surveillance group (<i>n</i> = 248) was 30 months.</p>\\n </section>\\n \\n <section>\\n \\n <h3> Results</h3>\\n \\n <p>Sensitivity at moderate threshold was 96% and specificity at positive threshold was 99% for MPTXv2. At 14% disease prevalence, the negative predictive value at the moderate threshold was 99% and the positive predictive value at the positive threshold was 89% for MPTXv2. MPTXv2 had fewer patients classified into the moderate-risk group than MPTXv1, which was statistically significant (<i>p</i> < .001). Using surgical resection, the gold standard for outcomes, MPTXv2 showed a statistically greater area under the curve (<i>p</i> = .028) than MPTXv1, demonstrating greater accuracy for MPTXv2.</p>\\n </section>\\n \\n <section>\\n \\n <h3> Conclusion</h3>\\n \\n <p>Both test versions demonstrated robust performance with low false-positive molecular results. 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The role of the ThyGeNEXT oncogene panel used in combination with the expanded miRNA panel ThyraMIRv2 in Indeterminate thyroid nodules: A large, blinded, real-world, observational study
Background
Molecular analysis of fine-needle aspiration biopsies (FNAB) improves the diagnostic accuracy of cytologically indeterminate thyroid nodules (ITNs). Recently, the use of MPTXv2 has been shown to further improve the accuracy of risk stratification of ITNs.
Methods
A total of 338 patient samples with atypia of undetermined significance (n = 258) or follicular neoplasm (n = 80) cytology diagnosis and corresponding surgical outcomes or clinical follow-up, collected between 2016 and 2020 were included [Correction added on 19 June 2024, after first online publication: In the preceding sentence, the n values 260 and 78 have been changed to 258 and 80, respectively.]. All samples underwent multiplatform testing (MPTXv1), which includes an oncogene panel (ThyGeNEXT®) plus a microRNA risk classifier (ThyraMIR®). A blinded, secondary analysis was performed to assess the added utility of MPTXv2 (ThyraMIR®v2). The average length of follow-up for the surveillance group (n = 248) was 30 months.
Results
Sensitivity at moderate threshold was 96% and specificity at positive threshold was 99% for MPTXv2. At 14% disease prevalence, the negative predictive value at the moderate threshold was 99% and the positive predictive value at the positive threshold was 89% for MPTXv2. MPTXv2 had fewer patients classified into the moderate-risk group than MPTXv1, which was statistically significant (p < .001). Using surgical resection, the gold standard for outcomes, MPTXv2 showed a statistically greater area under the curve (p = .028) than MPTXv1, demonstrating greater accuracy for MPTXv2.
Conclusion
Both test versions demonstrated robust performance with low false-positive molecular results. Data suggest that incorporation of MPTXv1, and more recently MPTXv2, into clinical practice within our healthcare network resulted in improved accuracy of ITN risk stratification.
期刊介绍：
Cancer Cytopathology provides a unique forum for interaction and dissemination of original research and educational information relevant to the practice of cytopathology and its related oncologic disciplines. The journal strives to have a positive effect on cancer prevention, early detection, diagnosis, and cure by the publication of high-quality content. The mission of Cancer Cytopathology is to present and inform readers of new applications, technological advances, cutting-edge research, novel applications of molecular techniques, and relevant review articles related to cytopathology.
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