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Clinical performance of multiplatform mutation panel and microRNA risk classifier in indeterminate thyroid nodules.

  • Sistrunk, J Woody1
  • Shifrin, Alexander2
  • Frager, Marc3
  • Bardales, Ricardo H4
  • Thomas, Johnson5
  • Fishman, Norman6
  • Goldberg, Philip7
  • Guttler, Richard8
  • Grant, Edward9
  • 1 Jackson Thyroid & Endocrine Clinic, Jackson, Mississippi. Electronic address: [email protected]
  • 2 Department of Surgery, Hackensack Meridian Health Jersey Shore University Medical Center, Neptune, New Jersey. , (Jersey)
  • 3 East Coast Medical Associates, Boca Raton, Florida.
  • 4 Precision Pathology/Outpatient Pathology Associates, Sacramento, California.
  • 5 Mercy Clinic Endocrinology, Springfield, Missouri.
  • 6 Diabetes & Endocrinology Specialists, Chesterfield, Missouri.
  • 7 Endocrine Associates of Connecticut, Branford, Connecticut.
  • 8 Thyroid Center of Santa Monica, Santa Monica, California.
  • 9 Department of Radiology, Keck School of Medicine, University of Southern California, Los Angeles, California.
Published Article
Journal of the American Society of Cytopathology
Publication Date
Jan 01, 2020
DOI: 10.1016/j.jasc.2020.02.002
PMID: 32247769


We evaluated the clinical performance of an expanded mutation panel in combination with microRNA classification (MPTX) for the management of indeterminate thyroid nodules. MPTX included testing of fine-needle aspirates from multiple centers with a combination of ThyGeNEXT mutation panel for strong and weak driver oncogenic changes and ThyraMIR microRNA risk classifier (both from Interpace Diagnostics; Pittsburgh, PA). MPTX test status (positive or negative) and MPTX clinical risk classifications (low, moderate, or high risk) were determined blind to patient outcomes. Surgical pathology and clinical follow-up records of patients from multiple centers were used to determine patient outcomes. MPTX performance was assessed by Kaplan Meier analysis for cancer-free survival of patients, with risk of malignancy determined by hazard ratio (HR). Our study included 140 patients with AUS/FLUS or FN/SFN nodules, of which 13% had malignancy. MPTX negative test status and MPTX low risk results conferred a high probability (94%) that patients would remain cancer-free. MPTX positive test status (HR 11.2, P < 0.001) and MPTX moderate-risk results (HR 8.5, P = 0.001) were significant risk factors for malignancy, each conferring a 53% probability of malignancy. MPTX high-risk results elevated risk of malignancy even more so, conferring a 70% probability of malignancy (HR 38.5, P < 0.001). MPTX test status accurately stratifies patients for risk of malignancy. Further classification using MPTX clinical risk categories enhances utility by accurately identifying patients at low, moderate, or high risk of malignancy at the low rate of malignancy encountered when clinically managing patients with indeterminate thyroid nodules. Copyright © 2020 The Authors. Published by Elsevier Inc. All rights reserved.

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