Ciarletto, AM, Narick, C, Malchoff, CD, et al. Analytical and Clinical Validation of Pairwise MicroRNA Expression Analysis to Identify Medullary Thyroid Cancer in Thyroid Fine-Needle Aspiration Samples. Cancer Cytopathology. https://doi.org/10.1002/cncy.22365

This study demonstrated the analytical and clinical validity of a pairwise microRNA (miRNA) analysis for the detection of medullary thyroid cancer (MTC) using ThyraMIR® Thyroid miRNA Classifier.

miRNA classification was based on a clinically validated panel of 10 specific miRNAs performed by quantitative real-time polymerase chain reaction. Diff-pair analysis was performed by subtracting the critical threshold value of one miRNA from the critical threshold values of other miRNAs. Next-generation sequencing with the ThyGeNEXT® mutation panel identified oncogenic gene alterations.

The discovery cohort consisted of 30 formalin-fixed, paraffin-embedded benign and malignant thyroid neoplasms, including 4 cases of MTC. After analytical validation, clinical validation was performed using 3 distinct cohorts (a total of 7,557 specimens). Clinical FNA samples included dedicated needle passes placed directly into preservative solution or cytology slides.

The assay correctly classified all MTC and non-MTC samples in the analytical validation study and in the 3 clinical validation cohorts. Pairwise analysis further demonstrated that, when compared with the other 9 miRNAs of the ThyraMIR® panel, miR-375 was highly expressed in MTC but not in other thyroid histopathologic categories.

The overall test accuracy was 100% (95% confidence interval, 99%-100%) and the specificity was 100% (95% CI, 99%-100%) in indeterminate FNA cytology samples. The sensitivity of the diff-pair analysis was greater than that of the MTC-specific mutation panel analysis (100% vs 25%; P=.03)

The use of this unique combination testing approach provided value to samples with a Bethesda III (atypia of undetermined significance/follicular lesion of undetermined significance) or IV (follicular neoplasm/suspicious for neoplasm) cytology diagnosis, particularly in the absence of cytological features of MTC.

Pairwise miRNA expression analysis of ThyraMIR® results accurately identified MTC in thyroid FNA samples, including those with indeterminate FNA cytology findings. 

Ciarletto, AM, Narick, C, Malchoff, CD, et al. Analytical and Clinical Validation of Pairwise MicroRNA Expression Analysis to Identify Medullary Thyroid Cancer in Thyroid Fine-Needle Aspiration Samples. Cancer Cytopathology. https://doi.org/10.1002/cncy.22365

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