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Going Beyond Mutational Analysis

ThyGeNEXT® + ThyraMIR®v2 is a unique testing platform that utilizes both mutational and microRNA markers1,2

Accurate risk stratification can help reduce unnecessary thyroid surgery and assist pre-operative patient counseling and surgical planning.3

Performance Matters1,4

98%

Sensitivity

98%

Specificity

99%

NPV1*

94%

PPV1,4*†

*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.1-5

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).1,4,5

Study Design1,2

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.

Tanya's Story

In this video, Tanya discusses her thyroid cancer journey and her experience with ThyGeNEXT+ThyraMIR.

Flexibility Matters

Interpace Diagnostics is the only company that offers:

Thyroid Mutation Panel + microRNA Risk Classifier

Testing of fresh FNA samples or direct smears/ThinPrep® slides with a high-quality image capture

No special shipping or refrigeration requirements

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. Data on File. Interpace Diagnostics. 5. Ali SZ, et al. Thyroid. 2023;33(9):1039-1044. doi:10.1089/thy.2023.0141.