Utilization of direct smears of thyroid fine‐needle aspirates for ancillary molecular testing: A comparison of two proprietary testing platforms

Partyka, Kristen L.; Randolph, Melissa; Lawrence, Karen A.; Cramer, Harvey; Wu, Hao

doi:10.1002/dc.23902

Cited by 16 publications

(21 citation statements)

References 17 publications

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“…In contrast, there is little data published regarding the use of RosettaGX Reveal in clinical practice . The initial validation studies and our personal experience support its utility as a rule‐out test based on the miRNA expression profile in thyroid aspirates . Additionally, Interpace created a multistep algorithm to assess risk of malignancy.…”

Section: Discussionmentioning

confidence: 99%

“…Based on the clinicians' preference, our institution has utilized ancillary testing with Afirma GEC/GSC since 2014. To provide more options, we recently performed a study to evaluate routinely stained cytology smears with platforms from Rosetta Genomics and Interpace Diagnostics . Our clinicians have decided to request Afirma as the primary test and Interpace as an alternate when necessary.…”

Section: Methodsmentioning

confidence: 99%

“…The initial validation studies for these molecular assays enrolled aspirates from all indeterminate categories (Bethesda III‐V) . We applied a similar approach and incorporated all indeterminate aspirates during our internal validation of Rosetta and Interpace . A SM diagnosis (Bethesda V) implies a high pretest probability of malignancy and directly impacts the test performance.…”

Section: Methodsmentioning

confidence: 99%

“…In comparison, Rosetta Genomics (Rehovot, Israel) and Interpace Diagnostics (Parsippany, NJ) developed assays that can utilize direct smears as the testing substrate . We previously conducted a retrospective study to evaluate the use of direct smears with these platforms . Both algorithms incorporate testing for microRNAs (miRNAs), which are involved in regulating gene transcription and cellular function .…”

Section: Introductionmentioning

confidence: 99%

“…Our recent validation with cytology smears provided support to the growing data in the literature. The decision to perform molecular testing can potentially be made after the time of procurement …”

Section: Introductionmentioning

confidence: 99%

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Risk of malignancy and neoplasia predicted by three molecular testing platforms in indeterminate thyroid nodules on fine‐needle aspiration

Partyka

Trevino

Randolph

et al. 2019

Diagnostic Cytopathology

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BACKGROUND The management of thyroid nodules with indeterminate cytology is challenging. Recently, molecular testing on fine‐needle aspirates (FNAs) has been advocated to determine whether clinical follow‐up or surgery is warranted for patients. Three different testing platforms were performed on aspirates from our institution (Afirma Thyroid FNA Analysis, RosettaGX Reveal, and Interpace ThyGenX/ThyraMIR). This study compares their diagnostic efficacy. METHODS We conducted a retrospective analysis of indeterminate thyroid FNAs with correlating molecular testing over 4 years (2015‐2018). The aspirates included diagnoses of follicular lesion of undetermined significance, follicular neoplasm, or suspicious for malignancy (SM). Based on cases that underwent surgical resection (Afirma, n = 37; Rosetta, n = 19; Interpace, n = 14), we calculated sensitivity, specificity, positive predictive value (PPV), and negative predictive value (NPV) for risk of malignancy and neoplasia. RESULTS The three tests performed similarly when predicting risk of malignancy. They showed high sensitivity (80‐100%) and NPV (90‐100%) but lower specificity (10‐64%) and PPV (21‐44%). When assessing their value to predict neoplasia, each test had a high PPV (76‐89%) but low NPV (20‐33%). The sensitivity for neoplasm was intermediate to high (50‐93%), and the specificity remained extremely variable (11‐67%). CONCLUSION Overall, these molecular platforms performed similarly, displaying high NPV but low to intermediate PPV for malignancy and low NPV but high PPV for neoplasm. The risk of neoplasm is a good index for surgery, and we argue that many of the neoplasms are low‐risk tumors. We endorse conservative treatment with lobectomy for cases that are indeterminate at FNA but suspicious by molecular testing.

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Section: Discussionmentioning

confidence: 99%

Section: Methodsmentioning

confidence: 99%

Section: Methodsmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

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Risk of malignancy and neoplasia predicted by three molecular testing platforms in indeterminate thyroid nodules on fine‐needle aspiration

Partyka

Trevino

Randolph

et al. 2019

Diagnostic Cytopathology

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Determining the molecular test for indeterminate thyroid nodules best suited for our practice: A quality assurance study

Maerki

Klein

Chau

et al. 2018

Diagnostic Cytopathology

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IntroductionCurrently, molecular studies are widely used as a guiding tool in further management of cytologically indeterminate thyroid nodules. At our institution, clinicians have recently expressed concern over receiving “less positive molecular results” upon switching from an extended 14 gene mutation panel (EGMP) to a 7 gene mutation panel (GMP). Our goal is to compare outcomes of these two tests in regards to the performance characteristics and clinical impact.Materials and MethodsAll thyroid fine‐needle aspiration (FNA) biopsy specimens sent for molecular studies from 2016 to 2017 were retrospectively studied. Cytopathology diagnosis, pertinent clinical findings, molecular results, and follow‐up (F/U) surgical and cytology diagnoses were recorded.ResultsOf the total 165 cases sent for molecular tests 86 (52%) were GMP and 79 (47%) EGMP. There were 21 (24%) and 40 (50%) cases with positive GMP and EGMP results, respectively. Within these positive cases (n = 61), there were a total of 33 (54%) patients who underwent surgical resection and 28 (45%) patients had no follow‐up. The molecular findings and surgical pathologic diagnoses obtained are illustrated in Figures 1 through 4 for GMP and EGMP, respectively.ConclusionsThe selection of molecular testing should be directed toward optimizing patient care and facilitate clinical management. This quality assurance study helped in understanding the complexities associated with test selection best suited for our institution and in educating clinicians.

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Testing for Afirma in Thyroid Nodules with High-Risk Indeterminate Cytology (TIR3B): First Italian Experience

Andrioli¹,

Carocci²,

Alessandrini³

et al. 2020

Endocr Pathol

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Utilization of direct smears of thyroid fine‐needle aspirates for ancillary molecular testing: A comparison of two proprietary testing platforms

Abstract: This study demonstrates that two molecular testing platforms performed equally well using our stained direct smears. Both molecular tests revealed a 100% negative predictive rate. RosettaGX showed a 75% positive predictive value in comparison to 60% for ThyGenX/ThyraMIR.

Cited by 16 publications

References 17 publications

Risk of malignancy and neoplasia predicted by three molecular testing platforms in indeterminate thyroid nodules on fine‐needle aspiration

Risk of malignancy and neoplasia predicted by three molecular testing platforms in indeterminate thyroid nodules on fine‐needle aspiration

Determining the molecular test for indeterminate thyroid nodules best suited for our practice: A quality assurance study

Testing for Afirma in Thyroid Nodules with High-Risk Indeterminate Cytology (TIR3B): First Italian Experience

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