An MIR-PANEL for Distinguishing Benign from Malignant Thyroid Nodules

Technology Overview

Thyroid cancer typically presents as a thyroid nodule and 5 to 15% of all thyroid nodules will prove to be malignant. Currently the gold standard for evaluating thyroid nodules is fine-needle-aspiration (FNA). FNA results in a definitive classification in approximately 70-80% of cases, while the remaining 20-30% of samples are characterized as indeterminate. These lesions show a follicular growth pattern and FNA is not sufficient to distinguish between benign and malignant lesions. Indeterminate FNA lesions present a problem for both the patient and the clinician since at least 20% harbor a malignant diagnosis and require at least a hemithyroidectomy for determining final diagnosis. When the definitive diagnosis is consistent with malignancy, patients typically undergo a second surgical procedure in the form of a completion thyroidectomy. Furthermore, since 80% of indeterminate lesions are benign on final pathology a significant number of patients undergo potentially avoidable surgery with its inherent risks and costs.

The inventors have used a combination of expression of 4 MicroRNAs (via RT-PCR) and a software with specific developed parameters (derived in-house experiments) to calculate the likelihood of an indeterminate lesion being benign versus malignant and found this test to be highly accurate (sensitivity 100%, specificity 95%). A study of 52 indeterminate thyroid FNA samples showed that the expression of the 4 MicroRNAs combined in a predictive model is highly accurate at differentiating benign from malignant indeterminate thyroid lesions on FNA.

Potential Applications

• Determining malignancy of suspicious and indeterminate thyroid nodules
• Therapeutic regimens for patients can be confidently devised based on accurate results

Advantages

• Ability to differentiate between benign and malignant tumors in a cost-effective manner, competitor's products are often unable to successfully predict malignancy and are much more expensive
• Objective diagnosis of thyroid nodules without the introduction of human error
• Unnecessary surgical removal of thyroid tissue (which is often associated with complications including loss of voice) can be avoided