Data Published in JCEM Demonstrate Strong Real-World Performance of Veracyte’s Afirma GSC in Thyroid Cancer Diagnosis

Meta-analysis of 13 independent studies suggests genomic test performs even better in real-world clinical practice as compared to original clinical validation study

Excerpt from the Press Release:

SOUTH SAN FRANCISCO, Calif.–(BUSINESS WIRE)–Veracyte, Inc. (Nasdaq: VCYT) today 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.

“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.”

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).

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