For the risk stratification of indeterminate thyroid nodules

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Confidence

Very High NPV and PPV1

Analysis of the Combined Mutational and microRNA Results Defines Risk of Malignancy Within Narrow Ranges1-3

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 mutations2
BRAF V600E • TERT Promoter • ALK • RET • RET/PTC • NTRK

Other commercially available tests utilize binary reporting, with NPVs and PPVs within their clinical validation studies being 96%/47% and 97%/66%, respectively.4,5

*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.1-3,6

†The Finkelstein, et al. study was designed to provide a deeper analysis of microRNA expression and evaluated study samples with the inclusion of surgical outcomes, resulting in an NPV of 99% and a PPV of 96%. When aligned to commercial specimen handling and reporting, the NPV and PPV are 99% and 94%, respectively, for atypia of undetermined significance (Bethesda III) and follicular neoplasm (Bethesda IV) thyroid nodules.1,3,6

‡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.

Observational Study of Combination Testing Performance Metrics Aligns with Clinical Validation Study1,7

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Observational Study Overview7

  • 338 consecutive patient samples with an atypia of undetermined significance (B-III) (n=258) or follicular neoplasm (B-IV) (n=80) cytological diagnosis and corresponding surgical outcomes or clinical follow-up, collected at 3 different centers within the Allegheny Health Network between 2016 and 2020
  • All samples underwent multiplatform testing, including microRNA pairwise expression profiling
  • During the follow-up period, averaging 30 months (range 8-72 months), none of the unresected nodules with negative molecular test results (n=235) developed clinical or sonographic evidence of malignancy
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*Within the observational study, unresected, molecular test-negative results were assumed to have benign reference diagnoses.7 Within the clinical validation study, negatives were determined to be benign with unanimous consensus histopathology diagnosis.1

†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.1-3,6

‡The Finkelstein, et al. study was designed to provide a deeper analysis of microRNA expression and evaluated study samples with the inclusion of surgical outcomes, resulting in an NPV of 99% and a PPV of 96%. When aligned to commercial specimen handling and reporting, the NPV and PPV are 99% and 94%, respectively, for atypia of undetermined significance (Bethesda III) and follicular neoplasm (Bethesda IV) thyroid nodules.1,3,6

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

Comparative Overview of Clinical Validation Studies

Test CharacteristicsThyGeNEXT® + ThyraMIR®v21ThyroSeq GC®4Afirma GSC®5
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%3*†
66%47%
Cancer
Prevalence
30%*28%24%
Comparative Performance
(30% Cancer Prevalence)		NPV
99%*
97%395%3
PPV
94%3*†
69%355%3
Test Result Categories
  • Negative
  • Moderate
  • Positive
  • Negative
  • Positive
  • Negative
  • Suspicious
Sample Type Accepted
  • 1 Dedicated Pass
—or—
  • Diagnostic Cytology Slide
    (at least 80-100 follicular cells)
  • Cell Blocks/FFPE Slides
  • 1 Dedicated Pass
—or—
  • Diagnostic Cytology Slide
    (>200-300 follicular cells)
  • Cell Blocks/FFPE Slides
  • 2 Dedicated Passes
Number Of Clinical Validation
Studies for Current Test		 111415
Peer-reviewed Real-world Experience Data
CAP Accredited 
CLIA Certified 
New York State Clinical Lab Permit 
Detects BRAF V600E, RET/PTC
Test Can Detect MTC
Detects TERT Promoter and ALK Mutations ‡
Fixed Cytology Smears
Acceptable for Testing
High-quality Digital Slide
Image Captured and Stored
FNA Specimen Stored
Without Refrigeration up to 6 Weeks§
FNA Specimen Can Be Shipped
Without Ice Packs
Compact Shipping Kit to
Minimize Office Storage Needs
FNA Specimen Does Not Require
a Blackout Pouch

*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.1-3,6

†The Finkelstein, et al. study was designed to provide a deeper analysis of microRNA expression and evaluated study samples with the inclusion of surgical outcomes, resulting in an NPV of 99% and a PPV of 96%. When aligned to commercial specimen handling and reporting, the NPV and PPV are 99% and 94%, respectively, for atypia of undetermined significance (Bethesda III) and follicular neoplasm (Bethesda IV) thyroid nodules.1,3,6

‡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.

§When specimens are placed within the provided collection buffer.

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. Data on File. Interpace Diagnostics. 4. Steward DL, et al. JAMA Oncol. 2019;5(2):204-212. 5. Patel KN, et al. JAMA Surg. 2018;153(9):817-824. 6. Ali SZ, et al. Thyroid. 2023;33(9):1039-1044. doi:10.1089/thy.2023.0141. 7. Verma T, et al. Cancer Cytopathol. 2024;132(9):556-563. doi:10.1002/cncy.22829. 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.