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validation studies and in larger cohorts The molecular tests used in our study, Afirma GEC and ThyroSeq v2, have since been replaced by updated versions of each test: Afirma Genomic Sequencing Classifier and ThyroSeq v3. Early results suggest that it offers increased sensitivity and specificity over standard gene expression classifier/AFIRMA testing for detection of cancer in these indeterminate nodules. Background: Molecular tests such as the Afirma gene expression classifier (GEC) and mutational panels (such as ThyroSeq) have been introduced to help risk stratify cytologically indeterminate thyroid nodules with the aim to reduce the number of unnecessary thyroidectomies. Of nodules tested with ThyroSeq v2, 19% were mutation positive, 77% were mutation negative, and 4% were insufficient. “The Pittsburgh test can determine if you have an 80 to 100% risk of cancer and can offer the patient a total thyroidectomy up front, to avoid two surgeries,” Dr. Ferris says. eCollection 2018. In terms of “rule-out” abilities Thyroseq v3 (NLR 0.02; 95%CI: 0.0-2.69) surpassed Afirma GEC … Privacy, Help Please enable it to take advantage of the complete set of features! Preoperative Molecular Markers in Thyroid Nodules. Patients who underwent thyroid biopsy (April 2016 to June 2017). Long-term surveillance is necessary to assess the false-negative rate of these particular molecular tests. You've disabled JavaScript in your web browser. . 2021 Jan 1;7(1):70-77. doi: 10.1001/jamaoncol.2020.5935. So much is going on with these studies now and I suspect more doctors will recommend active surveillance for low-risk. 2018 Sep 1;103(9):3507-3510. doi: 10.1210/jc.2018-01081. ThyroSeq is an innovative test for thyroid nodules and cancer. JAMA Oncol. This usually leads to surgery despite the fact that most indeterminate nodules are benign. Further studies are required for comparison with other available molecular diagnostics and for newer tests as they are developed. University of California, Los Angeles. Thyroseq™ Results: ThyroSeq benign call rate was 71%. This study also compared the performance of ThyroSeq V3 GC with that of another commonly used test for thyroid nodules, the Afirma GSC (Veracyte Inc, South San Francisco, California), as reported elsewhere. 32 The assay was performed at the UPMC Molecular and Genomic Pathology laboratory. The most recent iteration of the test is version 3 (as of late 2019). Thyroid. The widespread use of medical imaging has spurred substantial growth in the detection of Refer to the specific Health Plan's procedure code list for management requirements. ThyroSeq® Genomic Classifier (GC) test utilizes next-generation sequencing to analyze DNA and RNA of 112 thyroid-related genes for four main classes of molecular alterations, including mutations, gene fusions, copy number alterations, and gene expression alterations The results are processed by a unique Genomic Classifier (GC) and reported as Positive or Negative 1 Long-Term Outcomes of Thyroid Nodule AFIRMA GEC Testing and Literature Review: An Institutional Experience. Zhao H, Jing W, Li W, Zhang Z, Cao J, Zhao L, Sun Y, Wang C, Wang Y, Guo H. J Cancer. Affirma has a high negative predictive value--i.e., if affirma says your tumor is ok (not suspicious or indeterminate), then its highly likely not cancer. 2019 Mar;30(1):8-15. doi: 10.1007/s12022-018-9560-5. The Role of Molecular Diagnostics in the Management of Indeterminate Thyroid Nodules. Afirma Versus miRInform. 2020 Oct 21;11(24):7276-7282. doi: 10.7150/jca.46086. Procedure addressed by this guideline Procedure code ThyroSeq 0026U Endocr Pathol. But It has a low positive predictive value--if it says your tumor is suspicious, there is still a really good chance it is not cancer. Would you like email updates of new search results? ClinicalTrials.gov NCT02681328. Goldner WS, Angell TE, McAdoo SL, Babiarz J, Sadow PM, Nabhan FA, Nasr C, Kloos RT. ThyroSeq v3, ThyraMIR microRNA and ThyGenX/ThyGeNEXT 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. Setting: Context: The test may enable physicians to confidently tailor surgery strategy or treatment options for patients whose thyroid nodules are cancerous or suspicious for cancer. The ThyroSeq v3 GC is a targeted next-generation sequencing test that interrogates selected regions of 112 thyroid cancer-related genes for point mutations, insertions/deletions, gene fusions, copy number alterations, or gene expression alterations. Molecular testing has reduced the need for diagnostic hemithyroidectomy for indeterminate thyroid nodules. Clipboard, Search History, and several other advanced features are temporarily unavailable. Molecular test performance. These 3 papers report the performance of these assays in evaluating Bethesda III and IV indeterminate biopsies. ThyroSeq Genomic Classifier (GC) (v.3) Afirma Xpression Atlas (XA) RNA sequencing test to measure deoxyribonucleic acid (DNA) alterations and RNA fusions in nearly 600 genes possibly linked to thyroid cancer XA is an add-on test to Afirma GSC. Epub 2020 Mar 17. There are a few reasons this might happen: To regain access, please make sure that cookies and JavaScript are enabled before reloading the page. Surveillance ultrasonography was available for 46 nodules (45 remained stable). The Afirma Medullary Thyroid Cancer (MTC), in conjunction with the Afirma Gene Expresssion Classifier (GEC) for indeterminate thyroid FNA cytopathology or following Afirma Gene Expression Classifier (GEC) with a result that is suspicious or malignant. Independent study of ThyroSeq v3 from the University of Pennsylvania of 415 Bethesda III-IV thyroid nodules. It did determine that I had the BRAF mutation in the smaller nodule. The 3-category microRNA and mutation panel combination test had a high PPV (positive predictive value) at 75% and high NPV (negative predictive value) at 97% (n=178) after prevalence adjustments.1 Prevalence-unadjusted, PPV and NPV were 74% and 95%, respectively, for the 3-category approach.1. The ThyroSeq v2.0 can help people avoid that two step process by assessing the risk of the tumor from the needle biopsy sample. Front Endocrinol (Lausanne). Careers. Some reports have suggested that samples with Hurthle cell predominance have higher false-positive rates on GEC testing, but data are … 54. Main outcome measure: Compare the diagnostic performance of Afirma Gene Expression Classifier (GEC) with that of ThyroSeq v2 next-generation sequencing assay. FOIA Thyroseq v3 showed the best overall performance (AUC 0.95; 95% confidence interval: 0.93-0.97), followed by Afirma GSC (AUC 0.90; 0.87-0.92) and Thyroseq v2 (AUC 0.88; 0.85-0.90). If you have, or suspect that you have, a thyroid nodule and would like to find a doctor in your area who performs the Afirma test, simply fill out the information form here. Afirma GEC vs. ThyroSeq v.2 in indeterminate thyroid nodules post best practices surgery [ Time Frame: 12 months. December 2017—ThyroSeq, a joint partnership between UPMC and CBLPath, announced the results of a double-blind, multicenter international study validating the performance of ThyroSeq V3 in thyroid nodules with indeterminate cytology. 2019 Nov;29(11):1594-1605. doi: 10.1089/thy.2019.0278. Objective: Diagnostic hemithyroidectomy was avoided in 28 patients tested with GEC (39%) and 49 patients tested with ThyroSeq v2 (62%). 2018 Jul;126(7):471-480. doi: 10.1002/cncy.21993. Participants: Afirma GEC or GSC™ — a gene-expression classifier that identifies biopsies as “benign” or “suspicious,” and; mir-THYtype™ — an mRNA-based classifier test. Molecular testing for indeterminate thyroid nodules: Performance of the Afirma gene expression classifier and ThyroSeq panel. Long-term surveillance is necessary to assess the false-negative rate of these particular molecular tests. Borowczyk M, Szczepanek-Parulska E, Olejarz M, Więckowska B, Verburg FA, Dębicki S, Budny B, Janicka-Jedyńska M, Ziemnicka K, Ruchała M. Endocr Pathol. As you were browsing something about your browser made us think you were a bot. Cancer Cytopathol. ThyroSeq® stratifies these nodules into those that are likely benign and may be observed and those that are likely malignant and require surgical management. This site needs JavaScript to work properly. Recent next-generation updates to both Afirma and ThyroSeq molecular tests show improved outcomes to help guide management of indeterminate … ThyroSeq v2 had higher specificity than Afirma GEC and allowed more patients to avoid surgery. ThyroSeq MOL.TS.270.A v2.0.2019 Procedures addressed The inclusion of any procedure code in this table does not imply that the code is under management or requires prior authorization. Find a Doctorfor the Afirma test. You will receive an email shortly with a list of practices in your area that offer the Afirma … Risk Stratification Study of Indeterminate Thyroid Nodules with a next-generation Sequencing Assay with Residual ThinPrep® Material. Afirma also offers malignancy classifiers to guide physicians in choosing between surgery and observation. Prevention and treatment information (HHS). https://www.frontiersin.org/articles/10.3389/fendo.2020.590128 eCollection 2020. It uses DNA, mRNA, and miRNA markers for evaluation. Further studies are required for comparison with other available molecular diagnostics and for new … 8600 Rockville Pike SUMMARY OF THE STUDIES. J Clin Endocrinol Metab. Bethesda, MD 20894, Copyright A third-party browser plugin, such as Ghostery or NoScript, is preventing JavaScript from running. Results: 32 The genomic classifier was applied to assign … Intervention: 2018 Apr 18;9:179. doi: 10.3389/fendo.2018.00179. Negative Results on Thyroid Molecular Testing Decrease Rates of Surgery for Indeterminate Thyroid Nodules. A comparison of the diagnostic performance between the Afirma genomic sequencing classifier RNA test and the ThyroSeq v3 multigene genomic classifier DNA-RNA test revealed no statistically significant differences in sensitivity and specificity for diagnosis of malignancy in cytologically indeterminate thyroid nodules. After completing the CAPTCHA below, you will immediately regain access to the site again. Design: Accessibility Of nodules tested with GEC, 49% were suspicious, 43% were benign, and 9% were insufficient. You've disabled cookies in your web browser. No studies have directly compared molecular testing techniques. I ran AFIRMA and then another doc did a Quest Diagnostic Panel-- it tested about 7 genes, so not as comprehensive as the Thyroseq. You're a power user moving through this website with super-human speed. In recent years, the use of molecular marker testing on thyroid biopsy specimens has helped identify benign indeterminate nodules and avoid surgery. Trial registration: However, ThyroSeq v2 and ThyGenX/ThyraMIR showed a comparable PPV of 74–78%, which was significantly higher than the PPV than those of both, Afirma GEC and RosettaGX Reveal (37% and 43%, respectively). Parallel randomized trial, monthly block randomization of patients with Bethesda III/IV cytology to GEC or ThyroSeq v2. 2020 May;162(5):634-640. doi: 10.1177/0194599820911718. Otolaryngol Head Neck Surg. Testing with GEC or ThyroSeq v2. The ThyroSeq test has been in use for … alongside or reflexively to Afirma GSC. Livhits MJ, Zhu CY, Kuo EJ, Nguyen DT, Kim J, Tseng CH, Leung AM, Rao J, Levin M, Douek ML, Beckett KR, Cheung DS, Gofnung YA, Smooke-Praw S, Yeh MW. The specificities of GEC and ThyroSeq v2 were 66% and 91%, respectively (P = 0.002); the positive predictive values of GEC and ThyroSeq v2 were 39% and 57%, respectively. Sahli ZT, Smith PW, Umbricht CB, Zeiger MA. Epub 2019 Sep 27. Molecular Variants and Their Risks for Malignancy in Cytologically Indeterminate Thyroid Nodules. The Afirma XA provides physicians with genomic alteration information from the same FNA samples that are used in Afirma GSC testing. Effectiveness of Molecular Testing Techniques for Diagnosis of Indeterminate Thyroid Nodules: A Randomized Clinical Trial. Of 1372 thyroid nodules, 176 (13%) had indeterminate cytology and 149 of 157 eligible indeterminate nodules (95%) were included in the study. However, the shared gene panel tested by the prior and current versions of each test encompass the most commonly mutated genes in thyroid cancer (11, 29, 30). Additional information is available in this. With the use of ThyroSeq V2, 2 patients had false positive results, while 5 had true positive results. ThyroSeq had a high NPV of 98%; all missed cancers were ATA low risk. ThyroSeq v2 had higher specificity than Afirma GEC and allowed more patients to avoid surgery. Unable to load your collection due to an error, Unable to load your delegates due to an error. Epub 2018 Apr 10. National Library of Medicine Evaluation of 167 Gene Expression Classifier (GEC) and ThyroSeq v2 Diagnostic Accuracy in the Preoperative Assessment of Indeterminate Thyroid Nodules: Bivariate/HROC Meta-analysis. 2019 Jun;30(2):134-137. doi: 10.1007/s12022-019-9571-x. Thyroseq … ... PhD, of Moffitt Cancer Center in Tampa, Fla., who has worked with both Afirma and miRInform, said ThyroSeq "is the way the future is going to go." Up to 10-20% of thyroid biopsies are indeterminate, meaning that a diagnosis of cancer vs benign cannot be made on the basis of examining the cells alone. Conclusions: In terms of Specificity of the tests, we had only 4 patients with MMTs who had thyroidectomy; 1 in Afirma group which was true negative and 3 in ThyroSeq V2 group, 2 … The results were presented at the 87th Annual Meeting of the American Thyroid Association, Oct. 18–22, in Victoria, British Columbia, Canada.
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