Risk Stratification
Combination Testing With ThyGeNEXT and ThyraMIR Provides Accurate Reclassification1
ThyGeNEXT + ThyraMIR Combination Testing Performance1
High NPV
- Significant decrease in unnecessary surgeries
- 85% reduction relative to cytology alone (P<0.01)
Testing helps to risk-stratify the need for or extent of surgery needed
ATA and NCCN Guidelines support testing for nodules with a B-III or B-IV cytology diagnosis
50
%
Sensitivity
50
%
NPV
50
%
Specificity
40
%
PPV
Markers
Strategically Designed Panel for the Optimal Management of Thyroid Nodules
| ThyGeNEXT® NGS Panel | ThyraMIR® miRNA classifier | |
| DNA mutation panel | RNA panel (# fusions) | |
| ALK | ALK (2) | miR-29b-1-5p |
| BRAF | BRAF (2) | miR-31-5p |
| GNAS | NTRK (8) | miR-138-1-3p |
| HRAS | PPARg (6) | miR-139-5p |
| KRAS | RET (14) | miR-146b-5p |
| NRAS | THADA (5) | miR-155 |
| PIK3CA | mRNA controls: NKX2-1, PAX8, TBP, USP33 | miR-204-5p |
| PTEN | miR-222-3p | |
| RET | miR-375 | |
| TERT | miR-551b-3p | |
Newly added TERT and ALK mutations can reliably help to predict aggressive biological features of thyroid cancer, including:
- Large tumor size
- Higher patient mortality
- Likelihood of lymph node metastasis
- Higher rate of recurrence post-treatment
- Higher clinical stage at time of cancer detection
- Likelihood of cancer spreading beyond the thyroid
- Increased risk for tumor vascular invasion
- Potential for treatment failure
Long-Term Evidence
Impact of BRAF V600E or TERT C288T Alone or Their Coexistence on Disease-free Survival of Patients With PTC2
Coexisting BRAF V600E and TERT C228T mutations form a novel genetic background that defines PTC with the potentially worst clinicopathologic outcomes, providing unique prognostic and therapeutic implications.
Published Evidence
Numerous posters, papers, and articles have been published on the performance of ThyGeNEXT and ThyraMIR. Many of these have been presented at key industry conferences such as ATA and AACE.
References
- Labourier, et al, Journal Clinical Endocrinology Metabolism 100: 2743, 2015
- Xing M et al., BRAF V600E and TERT promoter mutations cooperatively identify the most aggressive papillary thyroid cancer with highest recurrence, Journal of Clinical Oncology 2014
