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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
80 %*1

NPV

Negative Samples

80 %*1

PPV

Positive Samples

*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

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®7Afirma GSC®8
Methodology
  • DNA Sequencing
  • RNA Sequencing
  • microRNA Classification
  • DNA Sequencing
  • RNA Sequencing
  • RNA Sequencing
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%995%9
PPV
96%*

Positive Samples

69%955%9
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 Bethesda III and IV nodules and based upon positive and negative thresholds.
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.

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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%.