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)

UnadjustedPrevalence 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

Prevalence adjustment of histopathologic subtypes improved test performance parameters

Comparative Overview of Molecular Tests

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

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

Comparative Overview of Molecular Tests

Test CharacteristicsThyGeNEXT® + ThyraMIR®1ThyroSeq GC®2Afirma GSC®3
Methodology
  • DNA Sequencing
  • RNA Sequencing
  • microRNA Classification
  • DNA Sequencing
  • RNA Sequencing
  • RNA Sequencing
Published Performance
(Bethesda III and IV Nodules)
Sensitivity95%*94%91%
Specificity90%*82%68%
NPV97%*97%96%
PPV75%*66%47%
Cancer
Prevalence
30%*28%24%
Test Result Categories
  • Negative
  • Moderate
  • Positive
  • Negative
  • Positive
  • Negative
  • Suspicious
Comparative Performance
(30% Cancer Prevalence)
NPV97%*97%595%5
PPV75%*69%555%5
Sample Type Accepted
  • 1 Dedicated Pass
—or—
  • Cell Blocks
  • Diagnostic Cytology Slide
    (>80 follicular cells)
  • 1 Dedicated Pass
—or—
  • Cell Blocks
  • Diagnostic Cytology Slide
    (>200-300 follicular cells)
  • 1 Dedicated Pass
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.

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.

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