Performance
ThyGeNEXT + ThyraMIR accurately ruled-in disease in four out of five nodules tested–including RAS-positive nodules1
ThyGeNEXT + ThyraMIR is the only testing platform that utilizes both mutational and microRNA markers
Demonstrated High Sp/PPV and Comparable Sn/NPV to Other Marketed Tests1-3*
Performance in Bethesda III and IV (n=178)
| Unadjusted | Prevalence Adjusted† | Sensitivity (Sn) | 93% | 95% |
|---|---|---|
| Specificity (Sp) | 90% | 90% |
| NPV (Negative Predictive Value) | 95% | 97% |
| PPV (Positive Predictive Value) | 74% | 75% |
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.1,2 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
Comparative Overview of Molecular Tests
*ThyroSeq® and Afirma® are trademarks of UPMC and Veracyte, Inc., respectively.
Comparative Overview of Molecular Tests
| Test Characteristics | ThyGeNEXT® + ThyraMIR®1 | ThyroSeq GC®2 | Afirma GSC®3 | Methodology |
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|---|---|---|---|---|
| Published Performance (Bethesda III and IV Nodules) | Sensitivity | 95%* | 94% | 91% |
| Specificity | 90%* | 82% | 68% | |
| NPV | 97%* | 97% | 96% | |
| PPV | 75%* | 66% | 47% | |
Cancer Prevalence | 30%* | 28% | 24% | |
| Test Result Categories |
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| Comparative Performance (30% Cancer Prevalence) | NPV | 97%* | 97%5 | 95%5 |
| PPV | 75%* | 69%5 | 55%5 | |
| Sample Type Accepted |
—or—
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—or—
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| Detects BRAFV600E, RET/PTC | ||||
| Test Can Detect MTC | ||||
| Detects TERT Promoter Mutations | ||||
| Detects ALK Mutations | † | |||
| Fixed Cytology Smears Acceptable for Testing | ||||
| High Quality Digital Slide Image Captured and Stored | ||||
| Sample Can Be Stored and Shipped Without Refrigeration | ||||
| Compact Shipping Kit to Minimize Office Storage Needs | ||||
*Performance prevalence-adjusted to histopathologic subtypes. 3-category performance aligned to clinical decision-making.
†The Afirma Xpression Atlas can detect ALK fusions.
ThyroSeq® and Afirma® are trademarks of UPMC and Veracyte, Inc., respectively.
Patient management decisions are based on the independent medical judgment of the physician and molecular test results should be taken into consideration in conjunction with all relevant imaging, clinical findings, patient and family history, as well as patient preference.
References
1. Lupo MA, et al. Diagn Cytopathol. 2020;1–11. https://doi.org/10.1002/dc.24564 2. Steward DL, et al. JAMA Oncol. 2019;5(2):204-212. 3. Patel KN, et al. JAMA Surg. 2018;153(9):817-824. 4. Usher-Smith JA, et al. BMJ. 2016;353:i3139. 5. Data on File.
