Oncology (thyroid), mutation analysis of 10 genes and 37 RNA fusions and expression of 4 mRNA markers using next-generation sequencing, fine needle aspirate, report includes associated risk of malignancy expressed as a percentage.
In Indeterminate Thyroid Nodules
Validation Study Demonstrates the High Value of Combination Testing in Risk‑stratifying Patients1*
*Performance prevalence-adjusted to histopathologic subtypes. 3-category performance aligned to clinical decision-making in Bethesda III and IV nodules.1,2
Multicenter, retrospective, blinded validation study of 309 subjects with indeterminate thyroid nodules (Bethesda III, IV, or V) and corresponding surgical histology. Gold-standard unanimous consensus histopathology diagnosis (n=197) among three pathologists was used, and all molecular testing was performed using archived cytology smears. Results were reported in 3 categories (negative, moderate, or positive) based on the combined test results from both ThyGeNEXT® (mutation panel) and ThyraMIR® (microRNA risk classifier). The proportion of benign and malignant histopathologic subtypes within this study vastly differed from those found within a recent prospective study.1,3 Histopathologic subtype prevalence adjustments were used to determine the impact of these differences on test performance.4 The analysis showed that test performance was optimal after prevalence adjustments.
The 3-category microRNA and mutation panel combination test had a high PPV (positive predictive value) at 75% and high NPV (negative predictive value) at 97% (n=178) after prevalence adjustments.1 Prevalence-unadjusted, PPV and NPV were 74% and 95%, respectively, for the 3-category approach.1
microRNA classification further risk-stratified patients with weak driver mutations, including RAS, resulting in four out of five nodules being accurately ruled-in or ruled-out for disease.1
Interpace Diagnostics is the only company that offers:
Parsippany, NJ, April 05, 2021 (GLOBE NEWSWIRE) — Interpace Biosciences, Inc. (“Interpace” or the “Company”) (OTCQX: IDXG) announced today that Novitas, its Medicare Administrative Contractor, has agreed to recognize the new
In-network status for ThyGeNEXT® and ThyraMIR® with State’s Largest Payer PARSIPPANY, NJ, Feb. 25, 2021 (GLOBE NEWSWIRE) — Interpace Biosciences, Inc. (“Interpace” or “the Company”), today announced that Blue Cross Blue Shield
In-network status for ThyGeNEXT® and ThyraMIR® with State’s Largest Payer PARSIPPANY, NJ, Jan. 28, 2021 (GLOBE NEWSWIRE) — Interpace Biosciences, Inc. (NASDAQ: IDXG) announced today that the Company’s Diagnostics group has entered
1. Lupo MA, et al. Diagn Cytopathol. 2020;1–11. https://doi.org/10.1002/dc.24564. 2. Banizs AB, Silverman JF. Diagn Cytopathol. 2019;47(4):268-274. 3. Steward DL, et al. JAMA Oncol. 2019;5(2):204-212. 4. Usher-Smith JA, et al. BMJ. 2016;353:i3139.
Interpace Diagnostics is a registered trademark and subsidiary of Interpace Biosciences, Inc.®
©2020 Interpace Biosciences, Inc.® All rights reserved.
