For the risk stratification of indeterminate thyroid nodules

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Why Go Beyond Mutational Analysis With microRNA?

microRNAs can rule in malignancy even in the absence of identified mutations1,2

ThyGeNEXT® + ThyraMIR®v2 is a unique testing platform that utilizes both mutational and microRNA markers1,2

microRNA Provides Deep Insight Into Gene Expression3

Thyroid neoplasia is expressed through both mutational and cellular-level control factors.1 

  • Mutations and fusions can change protein structure and function, impacting cellular growth and behavior4
  • microRNAs help regulate cellular growth and behavior by controlling protein synthesis and other regulatory functions, such as mRNA methylation3,5,6

microRNAs are master regulators of cellular activity—they control the types and amounts of proteins made by cells.7

Dysregulation of microRNAs is Common Across Cancer Types3

*Listings of microRNA markers may not be fully inclusive.

Bolded microRNAs are included in ThyraMIRv2

Dysregulated microRNAs have been shown to affect characteristics of cancer, such as10:

  • Cell proliferation
  • Growth suppression
  • Cell death
  • Cellular invasion and metastasis
  • Angiogenesis

The microRNAs assessed by ThyraMIRv211-13

microRNA (miR) Associated Functions
miR-31 Overexpressed in thyroid carcinoma
miR-146 Influences cell proliferation, migration, and invasion
miR-222 Tumorigenesis of PTC, expression correlated with ATA risk stratifications
miR-375 Plays an essential role in MTC tumorigenesis and progression
miR-551 Highly expressed in PTC
miR-21 Influences recurrence and metastases in PTC
miR-29 Upregulates TP53 and induces apoptosis in a TP53-dependent manner
miR-138 Associated with onset and aggressiveness of PTC
miR-139 Participates in important cancer-related signaling pathways
miR-155 Associated with aggressive tumor behavior and a more advanced TNM stage
miR-204 Distinguishes cancers from normal thyroid tissue, inhibits cell invasion

PTC=Papillary Thyroid Carcinoma; TNM=Tumor Node Metastasis: A cancer staging system that describes the extent of a tumor.

The microRNA assessed by ThyraMIRv2 help regulate both major and minor signaling pathways associated with thyroid carcinoma that can provide insight into at least 602 genes and potentially thousands more11*

*miR-375, AKT, ERK, PI3K; miR-222, Adipocytokine, JAK/STAT signaling pathway; miR-146b, DICER1 pathway, Wnt/β-Catenin pathway; miR-21, PI3K-AKT; miR-139, MAPK, PI3K; miR-29, TGF-β, Wnt, PI3K-AKT. This listing of microRNA markers is not fully inclusive of all the microRNAs assessed by ThyraMIRv2.

 

microRNAs have been shown to influence thyroid-cancer-related signaling pathways—such as the MAPK and PI3K/AKT pathways and RET gene11

Analysis of the Combination Testing Platform Results Provides Exceptional Utility1,2,14,15

98%

Sensitivity1,15

98%

Specificity1,15

99%

NPV1*

94%

PPV1,15*†

Patient management decisions are based on the independent medical judgment of the physician and molecular test results should be taken into consideration in conjunction with all relevant imaging, clinical findings, patient and family history, as well as patient preference.

*3-Category performance aligned to clinical decision-making in atypia of undetermined significance (Bethesda III) and follicular neoplasm (Bethesda IV) nodules. NPV and PPV are calculated from moderate and positive thresholds, respectively.1,2,15,16

†The Finkelstein, et al. study was designed to provide a deeper analysis of microRNA expression and evaluated study samples with the inclusion of surgical outcomes, resulting in an NPV of 99% and a PPV of 96%. When aligned to commercial specimen handling and reporting, the NPV and PPV are 99% and 94%, respectively, for atypia of undetermined significance (Bethesda III) and follicular neoplasm (Bethesda IV) thyroid nodules.1,15,16

References: 1. Finkelstein SD, et al. Thyroid. 2022;32(11):1362-1371. 2. Lupo MA, et al. Diagn Cytopathol. 2020;48(12):1254-1264. 3. Paranjape T, et al. Gut. 2009;58(11):1546-1554.  4. The genetics of cancer. National Cancer Institute. Accessed September 26, 2023. https://www.cancer.gov/about-cancer/causes-prevention/genetics/. 5. What is the “central dogma”? Your Genome. July 21, 2021. Accessed September 26, 2023. https://www.yourgenome.org/facts/what-is-the-central-dogma/. 6. Chen T, et al. Cell Stem Cell. 2015;16(3):289-301, 338. 7. O’Brien J, et al. Front Endocrinol (Lausanne). 2018;9:402. 8. Galvão-Lima LJ, et al. Biomed Eng Online. 2021;20(1):21. 9. Celano M, et al. Int J Genomics. 2017;2017:6496570. 10. Peng Y, et al. Signal Transduct Target Ther. 2016;1:15004. 11. Ghafouri-Fard S, et al. Noncoding RNA Res. 2020;5(3):88-98. 12. Bonneau E, et al. EJIFCC. 2019;30(2):114-127. 13. Wylie D, et al. J Pathol Clin Res. 2016;2(2):93-103.  14. Verma T, et al. Cancer Cytopathol. 2024;132(9):556-563. doi:10.1002/cncy.22829. 15. Data on File. Interpace Diagnostics. 16. Ali SZ, et al. Thyroid. 2023;33(9):1039-1044. doi:10.1089/thy.2023.0141.