Veracyte announces clinical validation data for Afirma GSC
Veracyte announced that an oral presentation of data from the pivotal clinical validation study of the Afirma Genomic Sequencing Classifier was presented at the 3rd World Congress on Thyroid Cancer held July 27-30 in Boston, Mass. The data demonstrate that the test, a next-generation version of the company's widely used Afirma Gene Expression Classifier, can identify 30% more benign thyroid nodules among those with "indeterminate" cytopathology - enabling these patients to avoid unnecessary diagnostic surgeries. The Afirma GSC uniquely combines RNA sequencing and machine learning to leverage more enriched, previously undetectable genomic information. Researchers validated the Afirma GSC on a prospective, multicenter, blinded cohort of 191 indeterminate thyroid nodule fine needle aspiration samples - the same sample set previously used to validate the first-generation Afirma GEC. Data shared by Dr. Patel at WCTC demonstrate that the Afirma GSC maintained the original test's high sensitivity and significantly increased its specificity, from 52% to 68%. The enhanced classifier's high specificity can identify 30% more patients with benign nodules compared to the Afirma GEC - allowing approximately 70% of patients with benign nodules to avoid unnecessary surgery when the cytopathology report is indeterminate. The Afirma GSC identifies benign Hurthle cells, which are usually very difficult to discern from cancer, with increased specificity of 59% compared with just 12% with the Afirma GEC. In addition, Veracyte will also provide classifiers for medullary thyroid cancer, the BRAF V600E variant and add classifiers to identify RET/PTC1 and RET/PTC3 fusions, which are almost always associated with cancer. These results provide additional value to further guide physicians on the extent of surgery to perform.