Veracyte, Inc. announced that findings demonstrating the strong real-world performance of the Afirma Genomic Sequencing Classifier (GSC) were published in The Journal of Clinical Endocrinology & Metabolism (JCEM). The data, from a meta-analysis of 13 independent studies, show that the Afirma GSC can accurately rule out thyroid cancer in patients with indeterminate thyroid nodules (ITNs) and that, when the test identifies a nodule as suspicious, the patient’s risk of malignancy is consistent with, and higher than, that reported in the test’s original clinical validation (CV) study.
“Our analysis found that the test performs just as well – and on some measures better – in clinical practice. This is incredibly encouraging and reassuring for physicians who must determine the best clinical approach for patients with indeterminate thyroid nodules.”
“The original Afirma GSC clinical validation study demonstrated that the genomic test provides reliable, accurate information to help inform important thyroid nodule diagnoses,” said Christian Nasr, M.D., division chief of Endocrinology at the University of Arizona College of Medicine and the lead author on the study. “Our analysis found that the test performs just as well – and on some measures better – in clinical practice. This is incredibly encouraging and reassuring for physicians who must determine the best clinical approach for patients with indeterminate thyroid nodules.”
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Among the 1,976 patients with ITNs included in the meta-analysis, researchers found that the Afirma GSC’s real-world ability to identify benign nodules (GSC-B) with high sensitivity and high negative predictive value for thyroid cancer was similar to the CV study results (97 percent vs. 91 percent and 99 percent vs. 96 percent, 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 (GSC-S; 65 percent positive predictive value vs. 47 percent).
Researchers reported a benign call rate (BCR) of 67%, which also surpassed the validation study (54% BCR), and is consistent with the 66% BCR reported by Hu, et al. in an analysis of 50,000 consecutive Afirma tests. Finally, the authors noted that only 6% of patients in the meta-analysis with GSC-B results had surgery, suggesting that most clinicians are comfortable monitoring these patients rather than conducting potentially unnecessary surgery.
SOURCE: Businesswire