Performance
Reduced False Positives and False Negatives and Optimized Risk Stratification of RAS Genes and Hurthle Cells1
Analysis of the Combined Mutational and microRNA Results Defines Risk of Malignancy Within Narrow Ranges1-4
The “Probability of Cancer or NIFTP” ranges above are not inclusive of all possible test results. These ranges can differ from what is shown due to varying cytologic results and additional relative differences between the algorithmic and profiler results.
Testing includes the strong driver Markers that Matter®2
BRAF V600E • TERT Promoter • ALK • RET • RET/PTC • NTRK
Other commercially available tests utilize binary reporting, with NPVs and PPVs of 96%/47% and 97%/66%, respectively.6,7
*3-category performance aligned to clinical decision-making in Bethesda III and IV nodules and based upon positive and negative thresholds.1-3†
†The mutation panel includes uncommon sequence variations and oncogenic fusions that may not be able to be classified as RAS-like (weak driver) mutations. When found, these uncommon sequence variations are commented upon individually.
The Finkelstein, et al. study was designed to provide a deeper analysis of microRNA expression, and therefore evaluated all study samples. When aligned to commercial specimen handling and reporting, the NPV and PPV are 99% and 94%, respectively (Bethesda III and IV nodules).1,5
ThyGeNEXT® Can Detect Strong Driver Mutations Useful in Prognosis and Surgical Decision-making1,8,9
Comparative Overview of Clinical Validation Studies
*ThyroSeq® and Afirma® are trademarks of UPMC and Veracyte, Inc., respectively.
Comparative Overview of Clinical Validation Studies
| Test Characteristics | ThyGeNEXT® + ThyraMIR®v21 | ThyroSeq GC®6 | Afirma GSC®7 | Methodology |
|
|
|
|---|---|---|---|---|
| Published Performance (Bethesda III and IV Nodules) | Sensitivity | 98%* Negative/Moderate Thresholds | 94% | 91% |
| Specificity | 98%* Positive Threshold | 82% | 68% | |
| NPV | 99%*1,5† Negative Threshold | 97% | 96% | |
| PPV | 94%*1,5† Positive Threshold | 66% | 47% | |
Cancer Prevalence | 30%* | 28% | 24% | |
| Comparative Performance (30% Cancer Prevalence) | NPV | 99%*1,5† Negative Threshold | 97%5,6 | 95%5,7 |
| PPV | 94%*1,5† Positive Threshold | 69%5,6 | 55%5,7 | |
| Test Result Categories |
|
|
| |
| Sample Type Accepted |
—or—
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—or—
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| |
| Detects BRAF V600E, 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 | ||||
†The Finkelstein, et al. study was designed to provide a deeper analysis of microRNA expression and therefore evaluated all study samples. When aligned to commercial specimen handling and reporting, the NPV and PPV are 99% and 94%, respectively (Bethesda III and IV nodules).1,5
‡The TERT promoter mutation is not part of the Afirma GSC or Xpression Atlas panels and is ordered separately. The 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. Finkelstein SD, et al. Thyroid. 2022;32(11):1362-1371. 2. Lupo MA, et al. Diagn Cytopathol. 2020;48(12):1254-1264. 3. Banizs AB, et al. Diagn Cytopathol. 2019;47(4):268-274. 4. Verma T, et al. Poster presented at ATA Annual Meeting; October 19-22, 2022; Montréal, Quebec, Canada. https://thyroiddx.com/allegheny/. 5. Data on File. Interpace Diagnostics. 6. Steward DL, et al. JAMA Oncol. 2019;5(2):204-212. 7. Patel KN, et al. JAMA Surg. 2018;153(9):817-824. 8. Panebianco F, et al. Endocr Relat Cancer. 2019;26(11):803-814. doi:10.1530/ERC-19-0325. 9. Pekova B, et al. Cancers (Basel). 2021;13(8):1932. doi:10.3390/cancers13081932.
