The Diagnostic Role of Thyroid Nodules

An Indeterminate FNA Finding

shutterstock_240397630Thyroid nodules are increasingly prevalent. Although 85% to 95% of thyroid nodules are benign,6,7 thyroid cancer is the most common endocrine cancer and ranks as the ninth most common cancer in the United States.2

Palpable thyroid nodules occur in 5% to 7% of the adult population, but only 5% to 15% of those are diagnosed as thyroid cancer. Fine needle aspiration (FNA) is currently the standard preoperative diagnostic procedure used to evaluate thyroid nodules for cancer risk.

 Cytologic examination results are often indeterminate

  • Up to 35% of FNA biopsy results are indeterminate.3
  • Among patients with cytologically indeterminate biopsies, the risk of malignancy can vary widely between institutions.3,8
  • ~66% of nodules obtained from diagnostic surgery (hemithyroidectomy) are benign.9

Molecular Testing After an Indeterminate FNA Can Add Clarity

thyroidbox

  • Molecular testing can improve risk assessment by identifying genetic alterations and/or changes in gene expression profiles associated with thyroid cancer.3,4
  • Improved risk assessment can help minimize the need for unnecessary surgeries, including identification of those patients who would benefit from total thyroidectomy rather than lobectomy.3,4

Coming Soon: Molecular Testing-Based Cytology Smear Slides

Interpace Diagnostics will soon be offering molecular testing based-cytology smear slides.
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Limitations and Disclaimers:

The ThyraMIR™ microRNA Classifier and the ThyGenX® Oncogene Panel each consist of markers strongly associated with thyroid cancer and whose detection in preoperative thyroid nodule aspirations have been shown to be highly predictive for thyroid cancer. These tests are intended to aid in the diagnosis of thyroid nodules with indeterminate cytology; positive or negative test results should be interpreted in conjunction with all other available clinical data. These tests were developed and performance characteristics determined by Interpace Diagnostics. They have not been cleared or approved by the FDA. The laboratory is regulated under CLIA as qualified to perform high-complexity testing used for clinical purposes. These tests are used for clinical purposes. Tests should not be regarded as investigational or for research. Final diagnosis and optimal patient management are the responsibility of the referring physician or health care provider.

References:

  1. Labourier E, Beaudenon A, Wylie D, Giordano TJ. Multi-categorical testing for miRNA, mRNA and DNA on fine needle aspiration improves the preoperative diagnosis of thyroid nodules with indeterminate cytology. ENDO 2015. Presented at the 97th Meeting and Expo of the Endocrine Society March 5-8, 2015. SAT-344.
  2. Surveillance, Epidemiology, and End Results (SEER) Program. Cancer statistics review 1975-2011. Section 26. thyroid. http://seer.cancer.gov/csr/1975_2011/
    results_merged/sect_26_thyroid.pdf. Accessed October 1, 2015.
  3. Beaudenon-Huibregtse S, Alexander EK, Guttler RB, et al. Centralized molecular testing for oncogenic gene mutations complements the local cytopathological diagnosis of thyroid nodules. Thyroid. 2014;24(10):1479-1487.
  4. Ferraz C, Eszlinger M, Paschke R. Current state and future perspective of molecular diagnosis of fine-needle aspiration biopsy of thyroid nodules. J Clin Endocrinol Metab. 2011;96(7): 2016-2206.
  5. Data on File Packet 0001. Interpace Diagnostics. Parsippany, NJ.
  6. Cooper DS, Doherty GM, Haugen BR, et al. Revised American Thyroid Association management guidelines for patients with thyroid nodules and differentiated thyroid cancer. Thyroid. 2009;19(11):1167-214.
  7. Nikiforov YE, Nikiforova MN. Molecular genetics and the diagnosis of thyroid cancer. Nat Rev Endocrinol. 2011;7(10):569-580.
  8. National Comprehensive Cancer Network (NCCN). NCCN clinical practice guidelines in oncology. Thyroid carcinoma Version 2.2014. Available at: www.nccn.org. Accessed October 1, 2015.
  9. Wang CC, Friedman L, Kennedy GC, et al. A large multicenter correlation study of thyroid nodule cytopathology and histopathology. Thyroid. 2011;21(3):243-251.