Effective April 1, 2021, ThyGeNEXT® will be billed with Proprietary Laboratory Analysis (PLA) CPT code 0245U

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.

Overcome
Diagnostic Uncertainty

In Indeterminate Thyroid Nodules

Validation Study Demonstrates the High Value of Combination Testing in Risk‑stratifying Patients1*

Visit us at AACE Annual Meeting 2021 Product Theater Friday, May 28th •  3:45-4:05pm ET Presented by Dr. Mark Lupo “Informed Risk Stratification and Patient Management with ThyGeNEXT® and ThyraMIR®
Accurate risk stratification can help reduce unnecessary thyroid surgery and assist pre-operative patient counseling and surgical planning.2

Markers That MatterTM

Strategically designed rule-in / rule-out testing platform—maximizing your understanding of true negatives, true positives, and aggressive biological features of thyroid cancer

Performance Matters

Demonstrated High PPV and NPV*1

50 %
Sensitivity
Low Risk Category
50 %
Specificity
High Risk Category
50 %
NPV
Low Risk Category
40 %
PPV
High Risk Category

*Performance prevalence-adjusted to histopathologic subtypes. 3-category performance aligned to clinical decision-making in Bethesda III and IV nodules.1,2

Study Design

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

Flexibility Matters

Interpace Diagnostics is the only company that offers:

Testing of fresh FNA samples or direct smears/ThinPrep® slides

No special shipping or refrigeration requirements

Mutation panel + miRNA expression classifier

News

References

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.

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