microRNA Signatures and Mutational Analysis Can Provide
Confidence and Convenience
ThyGeNEXT® + ThyraMIR®v2 utilizes both mutational markers and microRNA signatures to provide very high NPV and PPV1,2
Molecular testing can help reduce surgeries on benign nodules and assist in pre-operative patient counseling.1-4
Confidence
Very High NPV and PPV
99% NPV1*
94% PPV1,5*†
70%-79% BCR3,5
98%1,5*
Sensitivity
98%1,5*
Specificity
Convenience
Simple Specimen Handling
No Ice Required
No refrigeration for storage or ice packs for shipping are needed
Light and Temperature Stable
FNA specimens do not require blackout pouches and are stable for up to six weeks at room temperature‡
Low Follicular Cell Volume
Slides only require at least 80-100 follicular cells for testing2
*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.1,2,5,6
†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.1,5,6
‡When specimens are placed within the provided collection buffer.
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.
Diagnostic Perspectives
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. Verma T, et al. Cancer Cytopathol. 2024;132(9):556-563. doi:10.1002/cncy.22829. 4. Chowdhury R, et al. Cancers (Basel). 2025;17(7):1156. 5. Data on File. Interpace Diagnostics. 6. Ali SZ, et al. Thyroid. 2023;33(9):1039-1044. doi:10.1089/thy.2023.0141.