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 FNAB slide(s), were classified in the Bethesda System as categories III or IV and, in selected cases, V. The test analyzes the mutational status of the BRAF V600E gene and the promoter region of the TERT C228T and C250T genes, markers of clinical diagnostic and prognostic utility. 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 relevant only to the nodule that was analyzed.