Clinical Evidence Supporting ThyGenX® and ThyraMIR™

Combined Test Performance in Multicenter Study (Prevalence: 32%) (n=109)1*

94%

NPV: Likelihood negative result is truly benign*

74%

PPV: Likelihood positive result is malignant*

85%

Reduction in unnecessary surgeries

89%

Sensitivity

85%

Specificity

Better Together

In a prospective study of thyroid nodules with indeterminate cytology (N=109), combination testing with ThyGenX® and ThyraMIR™ was found to be BOTH highly sensitive and highly specific.1

When both tests are negative (61% benign call rate), the residual risk of cancer is very low (6%).

*Results from a histologically blinded, multicenter, cross-sectional cohort study in nodules of indeterminate cytology and negative mutational status [AUS/FLUS or FN/SFN] (N=109).1

Based upon Negative Predictive Value (NPV) and Positive Predictive Value (PPV).

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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.