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Interpace Diagnostics Presents Data from Multicenter Registry Study of Thyroid Cancer

Clinical Lab Products

11-08-18

At the recent annual meeting of the American Thyroid Association, Interpace Diagnostics Group Inc, Parsippany, NJ, presented interim results from a multicenter study of patients with thyroid nodules indeterminate by cytology that underwent combined mutation (ThyGenX) and microRNA (ThyraMIR) testing in clinical practice.1 The data were presented by J. Woody Sistrunk, MD, founder of the Jackson Endocrine and Thyroid Clinic, which was one of nine sites that participated in the study.

“This data represents an important milestone for our company,” says Jack Stover, president and CEO of Interpace Diagnostics. “We now have the most up-to-date information that supports the clinical utility of our unique combination testing platform.”

For the past two years, data from more than 300 patients has been accumulated in support of the study. A main objective of the study is to establish the utility of the company’s ThyGenX mutational panel, in combination with its ThyraMIR microRNA classifier, for correctly identifying those patients for whom surgery is not necessary. Recently, Interpace launched an expanded mutation panel called ThyGeNEXT, which includes additional markers such as ALK, PTEN, RET, and TERT, among others.

According to the American Thyroid Association, approximately 15% to 30% of the 525,000 thyroid fine-needle aspirations (FNAs) performed in the United States each year are indeterminate based on standard cytological evaluation, and are thus candidates for ThyGeNEXT testing. ThyGeNEXT provides high predictive value for determining the presence of cancer in thyroid nodules. The test can improve risk stratification and surgical decisionmaking when standard cytopathology does not provide a clear diagnosis for the presence of cancer. ThyGeNEXT is covered by both Medicare and most commercial insurers.

Like ThyGenX, ThyGeNEXT utilizes next-generation sequencing (NGS) to identify more than 150 genetic alterations associated with all forms of thyroid cancer, including follicular, medullary, and papillary thyroid carcinomas. According to the American Cancer Society, thyroid cancer is the most rapidly increasing cancer in the United States, with rates tripling in the past three decades. Where thyroid nodule biopsy results are indeterminate—not clearly benign or malignant following traditional cytopathology review—most physicians have traditionally recommended thyroid surgery. Without the use of molecular testing, however, more than 70% of these surgical procedures have been found to be ultimately unnecessary, with the nodules being benign.

Molecular testing using ThyGenX has historically been shown to reduce the rate of unnecessary surgeries in indeterminate cases. To date, Interpace has performed ThyGenX and ThyraMIR testing on more than 25,000 patients. The company expects to continue collecting cases for the thyroid registry, which will provide the basis of a peer-reviewed publication examining the effects of ThyGenX and ThyraMIR testing on physicians’ treatment decisions in real-world settings. The company is also adding data to the thyroid registry in order to report on the utility of the expanded mutation panel, ThyGeNEXT, over time.

For more information, visit Interpace Diagnostics.

Reference

  1. Sistrunk J, Shifrin A, Frager M, et al. Outcomes of patients with thyroid nodules clinically tested using a combination of mutation and microRNA classification: interim results of a multicenter registry study [short call poster 42]. Thyroid. 2018;28(S1):A-184; doi: 10.1089/thy.2018.29071.sc.abstracts.

 

 

 

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