Performance
ThyGeNEXT® + ThyraMIR®v2 optimizes test performance to provide the highest NPV and PPV commercially available1
ThyraMIRv2 Increased Performance Across All Indeterminate Bethesda Categories1
Disease Prevalence=30%
Disease Prevalence=36%
Patients With a Very Low Residual Cancer Risk Can Avoid Surgery3,4
- Guidelines support that when the NPV of a diagnostic test is similar to a benign cytologic diagnosis (96.3%), molecular testing may be used to help inform malignancy risk in lieu of surgery
*3-Category performance aligned to clinical decision-making in Bethesda III and IV nodules and based upon positive and negative thresholds. Binary test performance metrics are 99% NPV and 75% PPV.1,2
Study Design
The validation cohort consisted of samples from a previously reported fully blinded, multi‐center, retrospective study in which combination testing with ThyGeNEXT® + ThyraMIR® was performed on archived FNA cytology slides from non‐consecutive subjects with indeterminate cytology. An H&E stained tissue section from the corresponding surgically resected nodule was submitted and reviewed by two independent pathologists, blinded to the molecular test results, to establish unanimous consensus diagnosis. Pairwise re-analysis of the Ct (Cycle threshold) values of the same microRNAs yielded unique microRNA expression profiles that are now reported as ThyraMIR®v2.1,2
ThyGeNEXT® Can Detect Strong Driver Mutations Useful in Prognosis and Surgical Decision Making1,5,6
ThyraMIR®v2 significantly improves the diagnostic accuracy of RAS genes, Minimally Invasive Follicular Carcinoma, low-grade PTC, and Hürthle cell predominant nodules1
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®7 | Afirma GSC®8 | Methodology |
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|---|---|---|---|---|
| Published Performance (Bethesda III and IV Nodules) | Sensitivity | 98%* Negative/Moderate Thresholds | 94% | 91% |
| Specificity | 98%* Positive Threshold | 82% | 68% | |
| NPV | 99%* Negative Samples | 97% | 96% | |
| PPV | 96%* Positive Samples | 66% | 47% | |
Cancer Prevalence | 30%* | 28% | 24% | |
| Comparative Performance (30% Cancer Prevalence) | NPV | 99%* Negative Samples | 97%9 | 95%9 |
| PPV | 96%* Positive Samples | 69%9 | 55%9 | |
| Test Result Categories |
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| 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 | ||||
Binary test performance metrics are 99% NPV and 75% PPV.1,2
†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. Finkelstein SD, Sistrunk JW, Malchoff CD, et al. A retrospective evaluation of the diagnostic performance of an interdependent pairwise microRNA expression analysis with a mutation panel in indeterminate thyroid nodules [published online ahead of print, August 9, 2022]. Thyroid. doi:10.1089/thy.2022.0124. 2. Lupo MA, et al. Diagn Cytopathol. 2020;1–11. https://doi.org/10.1002/dc.24564 3. Haugen BR, et al. Thyroid. 2016;26(1):1-133. doi:10.1089/thy.2015.0020. 4. National Comprehensive Cancer Network Clinical Practice Guidelines in Oncology – Thyroid Carcinoma. Version 1.2021, April 9, 2021. www.nccn.org. 5. Panebianco F, et al. Endocr Relat Cancer. 2019;26(11):803-814. doi:10.1530/ERC-19-0325. 6. Pekova B, et al. Cancers (Basel). 2021;13(8):1932. doi:10.3390/cancers13081932. 7. Steward DL, et al. JAMA Oncol. 2019;5(2):204-212. 8. Patel KN, et al. JAMA Surg. 2018;153(9):817-824. 9. Data on File.
