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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 • ALKRETRET/PTCNTRK

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 atypia of undetermined significance (Bethesda III) and follicular neoplasm (Bethesda IV) nodules. NPV and PPV are calculated from moderate and positive thresholds, respectively.1-3,5,10

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 (atypia of undetermined significance [Bethesda III] and follicular neoplasm [Bethesda IV] nodules).1,5,10

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.

ThyGeNEXT® Can Detect Strong Driver Mutations Useful in Prognosis and Surgical Decision-making1,8,9

ThyraMIR®v2 significantly improves the diagnostic accuracy of RAS genes and Hürthle-cell-predominant nodules1

Comparative Overview of Clinical Validation Studies

Compare ThyGeNEXT® + ThyraMIRv2® to ThyroSeq GC® and Afirma GSC®*

*ThyroSeq® and Afirma® are trademarks of UPMC and Veracyte, Inc., respectively.

Comparative Overview of Clinical Validation Studies

Test CharacteristicsThyGeNEXT® + ThyraMIR®v21ThyroSeq GC®6Afirma GSC®7
Methodology
  • DNA Sequencing
  • RNA Sequencing
  • microRNA Classification
  • DNA Sequencing
  • RNA Sequencing
  • RNA Sequencing
Published Performance
(Bethesda III and IV Nodules)
Sensitivity
98%*
94%91%
Specificity
98%*
82%68%
NPV
99%*
97%96%
PPV
94%5*
66%47%
Cancer
Prevalence
30%*28%24%
Comparative Performance
(30% Cancer Prevalence)
NPV
99%*
97%5,695%5,7
PPV
94%5*
69%5,655%5,7
Test Result Categories
  • Negative
  • Moderate
  • Positive
  • Negative
  • Positive
  • Negative
  • Suspicious
Sample Type Accepted
  • 1 Dedicated Pass
—or—
  • Diagnostic Cytology Slide
    (at least 80 follicular cells)
  • Cell Blocks
  • 1 Dedicated Pass
—or—
  • Diagnostic Cytology Slide
    (>200-300 follicular cells)
  • Cell Blocks
  • 2 Dedicated Passes
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

*3-Category performance aligned to clinical decision-making in atypia of undetermined significance (Bethesda III) and follicular neoplasm (Bethesda IV) nodules. NPV and PPV are calculated from moderate and positive thresholds, respectively.1-3,5,10

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 (atypia of undetermined significance [Bethesda III] and follicular neoplasm [Bethesda IV] nodules).1,5,10

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. 10. Ali SZ, et al. Thyroid. 2023;33(9):1039-1044. doi:10.1089/thy.2023.0141.

ThyGeNEXT® + ThyraMIR®v2

Bethesda III/IV (n=178)

  • The effect of disease prevalence on the NPV (±2 SD) of a ThyGeNEXT+ThyraMIRv2 Negative result is shown above.
  • The expected post-test probability for a patient with a negative ThyGeNEXT+ThyraMIRv2 result exceeds 90% at a disease prevalence below 84%.

ThyGeNEXT® + ThyraMIR®v2

Bethesda III/IV (n=178)

  • The effect of disease prevalence on the PPV (±2 SD) of a ThyGeNEXT+ThyraMIRv2 Positive result is shown above.
  • The expected post-test probability for a patient with a positive ThyGeNEXT+ThyraMIRv2 result exceeds 90% at a disease prevalence above 16%.