Veracyte says data shows ‘real world’ performance of Afirma GSC

Veracyte announced the publication of “real world” data showing that the Afirma(R) Genomic Sequencing Classifier (GSC) enables even more patients to avoid unnecessary surgery in thyroid cancer diagnosis compared to the company’s flagship, original Afirma Gene Expression Classifier (GEC). The findings are published online in Endocrine Practice, the journal of the American Association of Clinical Endocrinologists. In the study, researchers from Memorial Healthcare System in Hollywood, Fla., reviewed data from all patients in their practice whose thyroid nodules were deemed indeterminate (i.e., not clearly benign or cancerous) by cytopathology review and who subsequently received results from genomic testing with the Afirma GSC (n=139) or the Afirma GEC (n=481). They found that the Afirma GSC identified 47 percent more thyroid nodules as benign than the first-generation test (61.2 percent vs. 41.6 percent). Use of the next-generation test also reduced overall surgery rates among all patients with indeterminate thyroid nodules by 45 percent. The researchers determined that sensitivity for the Afirma GSC in their practice was 97 percent. The RNA sequencing-based Afirma GSC demonstrated especially strong performance in distinguishing benign from cancerous Hurthle cells – a category of thyroid cell that has historically been challenging to diagnose by cytopathology or molecular methods. The Afirma GSC identified 64.7 percent of Hurthle cell dominant biopsies as benign compared to 17.3 percent with the original test and dramatically reduced overall surgery referrals in this group by 57.3 percent. “Our data suggest that the Afirma GSC is helping us to further reduce unnecessary surgeries among our patients with indeterminate thyroid nodules by enhancing the original test’s specificity while maintaining its high sensitivity,” said R. Mack Harrell, M.D., cofounder of the Memorial Center for Integrative Endocrine Surgery and lead author of the new study. “A key reason for this change is the Afirma GSC’s ability to rule out cancer in Hurthle-dominant thyroid nodules. This is important because Hurthle-dominant cases comprise 22 percent of the indeterminate thyroid nodules we evaluate.”
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