The Role of the ThyroSeq v3 Molecular Test in the Surgical Management of Thyroid Nodules in the Canadian Public Health Care Setting

Chen, Tanya; Gilfix, Brian M.; Rivera, Juan; Sadeghi, N.; Richardson, Keith; Hier, Michael P.; Forest, Véronique-Isabelle; Fishman, Dina; Çağlar, Derin; Pusztaszeri, Marc; Mitmaker, Elliot J.; Payne, Richard J.

doi:10.1089/thy.2019.0539

Cited by 48 publications

(41 citation statements)

References 26 publications

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“…This finding is similar to the results published by Ohori and colleagues, who reported a BCR of 81% and 56% for Bethesda III and IV nodules, respectively 6 . Similar findings have been reported by Chen et al (BCR for Bethesda III vs Bethesda IV nodules, 71% vs 48%, respectively) 7 . This finding was expected given the higher likelihood of malignancy for nodules with Bethesda IV cytology (range, 10%‐40%) than for those with Bethesda III cytology (range, 6%‐18%), 8 and it confirms that Bethesda III cytology with a negative ThyroSeq v3 result will help to reduce health care costs.…”

Section: Discussionsupporting

confidence: 91%

“…This finding was expected given the higher likelihood of malignancy for nodules with Bethesda IV cytology (range, 10%‐40%) than for those with Bethesda III cytology (range, 6%‐18%), 8 and it confirms that Bethesda III cytology with a negative ThyroSeq v3 result will help to reduce health care costs. A limitation of this study and other similar studies 6,7 that have reported the performance of such molecular tests is the lack of long‐term follow‐up for nodules with a benign molecular signature.…”

Section: Discussionmentioning

confidence: 91%

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ThyroSeq v3 for Bethesda III and IV: An institutional experience

Desai

Lepe

Baloch

et al. 2020

Cancer Cytopathology

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Background The ThyroSeq v3 genomic classifier is a commercial molecular test that examines a wide spectrum of genomic alterations in a thyroid fine‐needle aspiration (FNA) sample and reports test results as either negative or positive. The authors report their institutional experience with ThyroSeq v3. Methods Thyroid FNA specimens diagnosed as either atypia of undetermined significance or follicular lesion of undetermined significance (AUS/FLUS) (Bethesda category III [Bethesda III] according to The Bethesda System for Reporting Thyroid Cytopathology) or follicular neoplasm/suspicious for follicular neoplasm (FN/SFN) (Bethesda IV) that had ThyroSeq v3 results available from December 2017 through October 2019 were retrieved for analysis. FNA diagnoses were correlated with ThyroSeq v3 results and follow‐up histopathology. Results In total, 415 cases (AUS/FLUS, n = 251; FN/SFN, n = 164) were retrieved: 294 (71%) were reported as ThyroSeq v3‐negative, and 121 (29%) were reported as ThyroSeq v3‐positive. The benign call rate (BCR) of ThyroSeq v3 for AUS/FLUS (82%; 206 of 251 cases) was significantly higher (P < .001) than that for FN/SFN (BCR, 54%; 88 of 164 cases). Histopathologic follow‐up was available for 127 cases (ThyroSeq v3‐positive, 96; ThyroSeq v3‐negative, 31), of which 57 were benign and 70 were malignant (including noninvasive follicular thyroid neoplasm with papillary‐like nuclear features). The negative predictive value of ThyroSeq v3 was significantly higher for AUS/FLUS (99.5%) than for FN/SFN (95.4%; P < .0294), given malignancy rates of 10% for AUS/FLUS and 30% for FN/SFN. Forty‐five unique combinations of genetic alterations were detected in the operated ThyroSeq‐positive cases, and there were only 5 false‐negative cases, comprised of 4 low‐risk neoplasms. Conclusions The high BCR of ThyroSeq v3 for AUS/FLUS prevents surgery in a majority of patients. The ThyroSeq v3 genomic classifier reveals the complexity of the genetic signature of indeterminate nodules.

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Section: Discussionsupporting

confidence: 91%

Section: Discussionmentioning

confidence: 91%

ThyroSeq v3 for Bethesda III and IV: An institutional experience

Desai

Lepe

Baloch

et al. 2020

Cancer Cytopathology

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“…Both these papers, as well as comparative study by Harrell and colleagues, suggested that the rate of surgical intervention was lower during the period when the newer test was utilized ( 39 ). However, discrepancies between these initial reports and experience from real world usage are already appearing; Chen and colleagues, for instance, found that the benign call rate of GEC was only 58% compared to the 74% reported in an earlier publication ( 40 , 41 ). Ultimately, as was learned in the case of Afirma-GEC and ThyroSeq V2, these initial findings and test performances need to be confirmed in both independent validation studies and in larger cohorts.…”

Section: Diagnostic Utilitymentioning

confidence: 89%

Thyroid Nodule Molecular Testing: Is It Ready for Prime Time?

Khan

Zeiger

2020

Front. Endocrinol.

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Cytologically indeterminate thyroid nodules remain a diagnostic and clinical challenge, and molecular testing has been advocated and advanced as a diagnostic modality to help guide treatment. While studies have expounded on the improved diagnostic certainty with these tests, data demonstrating meaningful clinical impact and supporting their routine use is still limited at best. In this review, we discuss the limitations regarding diagnostic accuracy, impact on surgical decision-making and outcomes, and cost-effectiveness of molecular testing. By highlighting the limitations of these tests, we aim to promote more thoughtful utilization of these tools in the management of thyroid nodules going forward.

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“…1 Although there is consensus that overdiagnosis is the main reason for increased incidence 2,3 mainly due to incidental thyroid nodules found on imaging screenings performed for reasons other than thyroid disease evaluation, 4 there has also been a true increase in the occurrence of thyroid cancer. 5 Fine-needle aspiration (FNA) cytology is the current gold standard for triaging patients with suspicious thyroid nodules detected clinically or on ultrasound (US), [6][7][8]…”

Section: Introductionmentioning

confidence: 99%

“…Fine-needle aspiration (FNA) cytology is the current gold standard for triaging patients with suspicious thyroid nodules detected clinically or on ultrasound (US), 6-8 and the six-tier Bethesda System for Reporting Thyroid Cytopathology attempts to standardize cytopathologic analysis. 9…”

Section: Introductionmentioning

confidence: 99%

Real-world, Prospective, and Multicenter Validation of a microRNA-based Thyroid Molecular Classifier

Santos

Rodrigues

Shizukuda

et al. 2020

Preprint

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Background The diagnosis of cancer in thyroid nodules with indeterminate cytology (Bethesda III/IV) is challenging as fine-needle aspiration (FNA), the gold standard method, has limitations, and these cases usually require diagnostic surgery. As approximately 77% of these nodules are not malignant, a diagnostic test accurately identifying benign thyroid nodules can reduce surgery rates. We have previously reported the development and validation of a microRNA-based thyroid molecular classifier for precision endocrinology (mir-THYpe) with high sensitivity and specificity, which could be performed directly from readily available cytological smear slides without the need for a new dedicated FNA. We sought to evaluate whether the use of this test in real-world clinical routine can reduce the rates of surgeries for Bethesda III/IV thyroid nodules and analyze the test performance. Methods We designed a real-world, prospective, multicenter cohort study. Molecular tests were performed in a real-world clinical routine with samples (FNA smear slides) prepared at 128 cytopathology laboratories. Patients were followed-up from March 2018 until surgery or until March 2020 (for those patients not recommended for surgery). The final diagnosis of thyroid tissue samples was retrieved from postsurgical anatomopathological reports. Results After applying the exclusion criteria, 435 patients (440 nodules) classified as Bethesda III/IV were followed-up. The rate of avoided surgeries was 52.5% for all surgeries and 74.6% for potentially unnecessary surgeries. After the statistical treatment of non-resected test-negative samples, the test achieved 89.3% sensitivity (95% CI 82-94.3), 81.65% specificity (95% CI 76.6-86), 66.2% positive predictive value (95% CI 60.3-71.7), and 95% negative predictive value (95% CI 91.7-97) at 28.7% (95% CI 24.3-33.5) cancer prevalence. The test influenced 92.3% of clinical decisions. Conclusions The reported data demonstrate that the use of the microRNA-based classifier in the real-world can reduce the rate of thyroid surgery with robust performance and significantly influence clinical decision-making.

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The Role of the ThyroSeq v3 Molecular Test in the Surgical Management of Thyroid Nodules in the Canadian Public Health Care Setting

Cited by 48 publications

References 26 publications

ThyroSeq v3 for Bethesda III and IV: An institutional experience

ThyroSeq v3 for Bethesda III and IV: An institutional experience

Thyroid Nodule Molecular Testing: Is It Ready for Prime Time?

Real-world, Prospective, and Multicenter Validation of a microRNA-based Thyroid Molecular Classifier

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