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Combination Testing

Combined Analysis and Reporting of Mutational and microRNA Markers Provides Exceptional Utility1-4

ThyGeNEXT® + ThyraMIR®v2 provides mutational analysis, microRNA algorithmic classification, and microRNA pairwise expression profiling1

Mutational Markers1,5-7

  • Diagnostic and prognostic Markers that Matter® aid patient management decisions
  • Identifies markers aligned to FDA-approved targeted therapies

microRNA Markers1

  • Improves classification of samples with no mutations, RAS‐like mutations, and Hürthle cell change
  • Effective in both benign and malignant histopathologic subtypes

ThyGeNEXT® is Strategically Designed to Include Well‑documented Worrisome Mutations

DNA mutation panel3RNA panel3 (# fusions)
*FDA-approved targeted therapies may be available, provided malignancy is confirmed.5,6
ALK*ALK (2)*
BRAF*BRAF (3)*
GNASNTRK (8)*
HRASPPARg (5)
KRASRET (14)*
NRASTHADA (5)
PIK3CAmRNA markers:
NKX2-1, PAX8, TBP, USP33
PTEN
RET*
TERT

Test results identify when mutations are aligned to FDA-approved targeted therapies5,6

TERT promoter and ALK mutations have been demonstrated to reliably help predict aggressive biological features of thyroid cancer8-11

  • Large tumor size
  • Higher patient mortality
  • Likelihood of lymph node metastasis
  • Higher rate of recurrence post-treatment
  • Potential for treatment failure
  • Higher clinical stage at time of cancer detection
  • Likelihood of cancer spreading beyond the thyroid
  • Increased risk of tumor
    vascular invasion
  • TERT promoter mutation helps predict response to radioactive iodine (I-131) therapy

ThyraMIRv2 microRNA analysis improves risk assessment of indeterminate thyroid nodules1

  • Algorithmic classification of microRNA upregulation and downregulation helps inform gene expression—providing a view into the cellular biology of pathological conditions3,12
  • Pairwise comparisons of the relationships between microRNA pairs can identify malignancy risk1

ThyGeNEXT + ThyraMIRv2 Detects Mutational and Non-mutational drivers of malignancy

Expression of thyroid neoplasia involves the combination of mutational and cellular-level (epigenomic) factors2

  • Mutations can change protein function which impacts cellular growth and behavior6
  • Cellular-level growth regulation includes differential microRNA expression which controls protein translation2

microRNA regulates protein synthesis—providing a view into the cellular biology of pathological conditions7

Unique 3-category Reporting
ThyGeNEXT + ThyraMIRv2 Testing Algorithm*1,3,13

*Testing algorithm based upon Bethesda Diagnostic Categories III (AUS/FLUS) and IV (FN/SFN).13

**3-category performance aligned to clinical decision-making in Bethesda III and IV nodules and based upon positive and negative thresholds.1,3,14

ThyGeNEXT samples that are positive for BRAF, TERT, and RET/PTC will solely receive a ThyGeNEXT report. ThyGeNEXT samples that do not result with a mutation or that test positive for markers that have a lower risk of malignancy, such as RAS, will receive a ThyraMIRv2 report.

NCCN guidelines for management of nodules with B-III and B-IV cytology diagnoses include consideration of molecular analysis.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.

References

1. Finkelstein SD, et al. Thyroid. 2022;32(11):1362-1371. 2. Data on File. Interpace Diagnostics. 3. Lupo MA, et al. Diagn Cytopathol. 2020;48(12):1254-1264. 4. Sistrunk JW, et al. J Am Soc Cytopathol. 2020;9(4):232-241. 5. Drugs Approved for Solid Tumors Anywhere in the Body. National Cancer Institute. Accessed May 20, 2022. www.cancer.gov/about-cancer/treatment/drugs/solid-tumors. 6. Drugs Approved for Thyroid Cancer. National Cancer Institute. Accessed May 20, 2022. www.cancer.gov/about-cancer/treatment/drugs/thyroid. 7. Haugen BR, et al. Thyroid. 2016;26(1):1-133. doi:10.1089/thy.2015.0020. 8. Liu X, et al. Endocr Relat Cancer. 2013;20(4):603-610. doi:10.1530/ERC-13-0210. 9. Melo M, et al. J Clin Endocrinol Metab. 2014;99(5):E754-E765. doi:10.1210/jc.2013-3734. 10. Yang X, et al. J Nucl Med. 2017;58(2):258-265. doi:10.2967/jnumed.116.180240. 11. Xing M. Nat Rev Cancer. 2013;13(3):184-199. doi:10.1038/nrc3431. 12. Boufraqech M, et al. Best Pract Res Clin Endocrinol Metab. 2016;30(5):603-619. 13. Cibas E, et al. Thyroid. 2017;27(11):1341-13,9,1046. doi:10.1089/thy.2017.0500. 14. Banizs AB, et al. Diagn Cytopathol. 2019;47(4):268-274. 15. NCCN guidelines. Version 2.2020, Thyroid Carcinoma – nodule evaluation, THYR-3.

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