Meta-analysis presented at ENDO 2022 provides real-world evidence that a test can accurately rule out thyroid cancer in patients with indeterminate thyroid nodules and that, when the test deems a nodule as suspicious, the patient’s risk of malignancy is consistent, and higher than that reported in the test’s original clinical validation (CV) study. Veracyte is marketing the test as the Afirma Genomic Sequencing Classifier (GSC).
Veracyte estimates that each year approximately 565,000 people undergo fine-needle aspiration (FNA) biopsy evaluation for potentially cancerous thyroid nodules and that more than 110,000 of these patients receive indeterminate results. Historically, most of these patients were directed to diagnostic surgery, even though 70% to 80% percent of the time, the nodules proved to be benign. Current American Thyroid Association guidelines include molecular testing as a recommended option to achieve definitive diagnosis for nodules classified as indeterminate following FNA biopsy.
In the new meta-analysis, researchers evaluated 13 independent studies and found that the Afirma GSC’s real-world ability to identify benign nodules with high sensitivity and high negative predictive value for thyroid cancer was similar to the CV study results (97% vs. 91% and 99% vs. 96%, respectively). Additionally, the meta-analysis data show that the Afirma test’s real-world performance surpasses that shown in the CV study when predicting the risk of malignancy in nodules labeled suspicious (65% positive predictive value vs. 47%).
“The Afirma GSC’s clinical validation study provided high-quality evidence of our test’s ability to rule out malignancy in indeterminate thyroid nodules to help these patients avoid unnecessary surgery,” says Joshua Klopper, MD, Veracyte’s medical director for endocrinology and an author of the study. “Our new findings show that the real-world experience supports this data, further demonstrating that the likelihood of malignancy in Afirma GSC-suspicious nodules is even greater than what was reported in the validation study.”