FAQs

To order, you first need to request a ThyGenX® and ThyraMIR™ Starter Kit by calling 844-405-9655. The kit consists of test requisition forms and sample collection and transportation supplies, all of which are provided at no charge. Once you receive these supplies, you will need to collect an extra FNA biopsy, express it into the provided preservative solution, and complete the requisition form, then ship these items using the included prepaid FedEx shipping label.

ThyGenX® and ThyraMIR™ are not yet available in the state of New York.

ThyGenX® and ThyraMIR™ require one dedicated FNA biopsy containing a minimum of 50 ng of tissue.
The quality and quantity of the nucleic acids within extracted FNA specimens are assessed by spectrophotometry. If sufficient sample is available, all attempts will be made to provide test results to the physician. If inadequate sample is present, the physician will be contacted for a replacement sample.
FNAs from the same nodule can be expressed into the same vial of preservation solution. However, FNAs from different nodules need to be expressed into separate vials, and the location of each nodule should be noted on the requisition form and labeled on the corresponding vial.
Results can be expected within 10 to 14 days from when the sample and completed test requisition form are received.
The provided preservative solution keeps FNA specimens good for up to six weeks at ambient temperature.

The markers that make up the ThyGenX® Oncogene Panel were selected based upon numerous clinical studies and publications for their high correlation with thyroid cancer risk.

Additionally, these markers are recommended by multiple guidelines, including those of the National Comprehensive Cancer Network (NCCN), to aid in the diagnosis and thyroid cancer risk assessment of patients with indeterminate thyroid nodules.8

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.