Go Beyond Mutational Analysis
ThyGeNEXT® + ThyraMIR®v2 is the only 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
Negative/Moderate Thresholds
98%
Specificity
Positive Threshold
NPV
Negative Threshold
PPV
Positive Threshold
*3-category performance aligned to clinical decision-making in Bethesda III and IV nodules and based upon positive and negative thresholds.1-3
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.
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.
