The ThyGenX® and ThyraMIR™ Molecular Diagnostic Report

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ThyGenX®

ThyGenX® Mutational Testing is a highly specific oncogene panel that assesses the most common genetic alterations across 8 genes associated with papillary carcinoma and follicular carcinoma.4,5

Positive:

81%

81% likelihood of malignancy when mutation is present3

Negative:

Proceed to ThyraMIR™

ThyraMIR™

ThyraMIR™ miRNA Gene Expression Classifier produces a positive result based on evaluation of expression of 10 miRNAs, and can identify malignancy in nodules that are negative for ThyGenX®, thereby improving overall sensitivity and ability to detect malignancy.1

Positive: (ThyGenX®/ThyraMIR™ combined test):

74%

74% likelihood positive result is malignant1

Negative: (ThyGenX®/ThyraMIR™ combined test):

94%

94% likelihood negative result is truly benign1

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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.