ThyroidPrint®: clinical utility for indeterminate thyroid cytology.

Area of Science:

• Endocrinology
• Oncology
• Molecular Diagnostics

Background:

• Indeterminate thyroid nodules (ITNs) pose diagnostic challenges, often requiring surgery to rule out malignancy.
• Molecular testing offers a potential solution to improve ITN diagnosis and guide clinical decisions.
• ThyroidPrint® is a ten-gene classifier designed to identify benign ITNs, reducing the need for invasive procedures.

Purpose of the Study:

• To evaluate the clinical utility and impact of ThyroidPrint® on physician decision-making for patients with ITNs.
• To assess the real-world effectiveness of ThyroidPrint® in reducing diagnostic surgeries for ITNs.
• To determine the benign call rate (BCR) and malignancy rate in surgically confirmed cases.

Main Methods:

• A prospective, single-center, noninterventional clinical utility study was conducted.
• Physicians' decisions regarding ITN management were analyzed before and after ThyroidPrint® testing.
• Data collected included nodule characteristics, molecular test results, BCR, and histopathological outcomes from surgery.

Main Results:

• The study included 1272 fine-needle aspirations, with 109 (8.6%) Bethesda III and 135 (10.6%) Bethesda IV ITNs.
• Molecular testing was performed on 155 ITNs, yielding a 67.1% benign call rate (BCR).
• Physicians opted for active surveillance in 99% of patients with benign ThyroidPrint® results, reducing diagnostic surgery by 67% for ITNs.

Conclusions:

• ThyroidPrint® effectively aids physicians in managing indeterminate thyroid nodules, significantly decreasing the rate of diagnostic surgeries.
• The molecular classifier demonstrates high utility in guiding clinical decisions, promoting active surveillance for benign-classified nodules.
• This study validates the real-world clinical benefit of ThyroidPrint® in optimizing patient care for ITNs.