(Bethesda III or IV) on FNA
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Molecular Classifier for Indeterminate Thyroid Nodule (Bethesda III or IV)
mir-THYpe full can help prevent diagnostic surgeries.
There are a high number of thyroid surgeries
that can be AVOIDED
The use of molecular classifiers to assist in the management of patients with an indeterminate thyroid nodule is suggested by the following guidelines
Haugen BR, et al. 2016 Thyroid.
NCCN Thyroid Carcinoma Clinical Practice Guidelines, v1.2017.
Rosário PW, et al, 2015 Thyroid nodule and differentiated thyroid cancer: update on the Brazilian consensus. Arq Bras Endocrinol Metab 57(4):240-2642
Molecular prognostic markers may predict a more or less aggressive behavior of the thyroid nodule.
Nodules with negative prognostic markers may be eligible for minor surgeries, such as partial surgery, which can preserve part of the thyroid function .
Customize your medical management with mir-THYpe full´s diagnostic and prognostic markers
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TUSS Code: 4.03.14.60.0
Patent No. BR 102018003587-8
The molecular classification test for an indeterminate thyroid nodule is indicated only for patients with indeterminate thyroid nodules, that is, those who in the cytological analysis of the slide(s) s) of PAAF were classified in the Bethesda System of categories III or IV and, in selected cases, V. The exam analyzes the mutational status of the BRAF V600E gene and the promoter region of the TERT gene C228T and C250T, markers of clinical diagnostic utility and prognosis. The test also analyzes a microRNA expression profile and, through a proprietary algorithm, accurately assists in the classification of indeterminate thyroid nodules by evaluating the molecular behavior of the sample for malignancy in “positive” or “negative”. The performance of the exam was calculated based on a validation study1 that compared the results obtained by mir-THYpe® full using genetic material extracted from samples of FNAC cytology slides from patients with indeterminate thyroid nodules, with the results of the exam post-surgical histology of the same nodules (according to the consensus of at least two independent cytopathologists). The classification algorithm has not been trained on samples from thyroid nodules with Bethesda classification I, II or VI or other tumor types and biological samples. The test also analyzes the isolated expression of microRNAs miR-146b (a biomarker that predicts potentially more aggressive behavior in papillary carcinoma) and miR-375 (a biomarker for medullary thyroid carcinoma). The results obtained using this test should be interpreted together and in context with other diagnostic and clinical findings to decide on the medical/clinical approach to be followed, especially on whether or not any surgical procedure is necessary, including surgical extension and the total or partial removal of the thyroid gland. The results obtained using this exam are only relevant to the nodule that was analyzed.
Marcos Tadeu dos Santos, Ph.D. – Molecular Biologist - CRBio No. 113094/01-D. Member of the Latin America Thyroid Society (LATS) and of the Thyroid Department of the Brazilian Society of Endocrinology and Metabolism (SBEM).
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