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

IF 2.6 3区医学 Q3 ONCOLOGY Cancer Cytopathology Pub Date : 2024-05-30 DOI:10.1002/cncy.22829

Tanvi Verma MD, Cody Marshall DO, Kossivi E. Dantey MD, Diane V. Thompson MS, Anna Banizs MD, Sydney D. Finkelstein MD, Joseph DelTondo DO

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Abstract

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.

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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。

背景：细针穿刺活检（FNAB）的分子分析提高了细胞学不确定甲状腺结节（ITNs）的诊断准确性。最近的研究表明，使用 MPTXv2 可进一步提高 ITN 风险分层的准确性：方法：共纳入2016年至2020年间收集的338份细胞学诊断为意义未定的不典型性（n = 260）或滤泡性肿瘤（n = 78）的患者样本，以及相应的手术结果或临床随访。所有样本都进行了多平台检测（MPTXv1），其中包括一个癌基因面板（ThyGeNEXT®）和一个微RNA风险分类器（ThyraMIR®）。为了评估 MPTXv2 (ThyraMIR®v2) 的附加效用，我们进行了一项盲法二次分析。监测组（n = 248）的平均随访时间为30个月：MPTXv2在中度阈值时的灵敏度为96%，在阳性阈值时的特异性为99%。在疾病流行率为 14% 的情况下，MPTXv2 在中度阈值下的阴性预测值为 99%，在阳性阈值下的阳性预测值为 89%。与 MPTXv1 相比，MPTXv2 被归类为中度风险组的患者更少，这在统计学上具有显著意义（p 结论：MPTXv2 和 MPTXv1 的中度风险预测值均高于 MPTXv1：两种测试版本都表现出强大的性能，分子结果的假阳性率较低。数据表明，将 MPTXv1 和最近的 MPTXv2 纳入我们医疗保健网络的临床实践，提高了 ITN 风险分层的准确性。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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来源期刊

Cancer Cytopathology 医学-病理学

CiteScore

7.00

自引率

17.60%

发文量

130

审稿时长

1 months

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.