Confidence and Convenience1-3
As Easy As 1-2-3...
ONE
Integrated Test Result
Malignancy risk clearly defined
TWO
Combined Assessments
Mutational analysis
microRNA signatures
THREE
High Performance Metrics
99% NPV1*
With Simple Specimen Handling
For storage or shipping
Light and Temperature
Stable‡
Slides only require at
least 80-100 follicular cells
Molecular testing can help reduce surgeries on benign nodules and assist in pre-operative patient counseling.1,2,4,5
Diagnostic Perspectives
Tanya's Story
In this video, Tanya discusses her thyroid cancer journey and her experience with ThyGeNEXT+ThyraMIR.
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.
Validation 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.
*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
‡When specimens are placed within the provided collection buffer.
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. Verma T, et al. Cancer Cytopathol. 2024;132(9):556-563. doi:10.1002/cncy.22829. 5. Chowdhury R, et al. Cancers (Basel). 2025;17(7):1156. 6. Ali SZ, et al. Thyroid. 2023;33(9):1039-1044. doi:10.1089/thy.2023.0141.