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Accurate risk stratification can help reduce unnecessary thyroid surgery and assist pre-operative patient counseling and surgical planning.2

Performance Matters

Demonstrated Highest PPV and NPV*1

80 %
Sensitivity
Negative/Moderate Thresholds
80 %
Specificity
Positive
Threshold
80 %
NPV
Negative
Samples
80 %
PPV
Positive
Samples

98%

Sensitivity

Negative/Moderate Thresholds

98%

Specificity

Positive Threshold

99%

NPV

Negative Samples

96%

PPV

Positive Samples

*3-Category performance aligned to clinical decision-making in Bethesda III and IV nodules and based upon positive and negative thresholds. Binary test performance metrics are 99% NPV and 75% PPV.1,3

Study Design1,3

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, Sistrunk JW, Malchoff CD, et al. A retrospective evaluation of the diagnostic performance of an interdependent pairwise microRNA expression analysis with a mutation panel in indeterminate thyroid nodules [published online ahead of print, August 9, 2022]. Thyroid. doi:10.1089/thy.2022.0124. 2. Banizs AB, Silverman JF. Diagn Cytopathol. 2019;47(4):268-274. 3. Lupo MA, et al. Diagn Cytopathol. 2020;1–11. https://doi.org/10.1002/dc.24564.

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