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New Data Show Strong Performance of Veracyte’s Afirma GSC in Real-World Clinical Practice
Meta-analysis of independent, real-world studies was presented at ENDO 2022 and shows even better Afirma GSC performance compared to original clinical
About this update from Veracyte, Inc.
[{"type":"text","content":"\nMeta-analysis of independent, real-world studies was presented at ENDO 2022 and shows even better Afirma GSC performance compared to original clinical validation study\n\n SOUTH SAN FRANCISCO, Calif.--(BUSINESS WIRE)--\nVeracyte, Inc. (Nasdaq: VCYT) today announced that findings from a new meta-analysis provide real-world evidence that the Afirma Genomic Sequencing Classifier (GSC) 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. The findings were presented for the first time at the ENDO 2022 Annual Conference (Poster LBSAT255).\n\n“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. 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,” said Joshua Klopper, M.D., Veracyte’s medical director for endocrinology and an author on the study.\n\nIn 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 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 (65 percent positive predictive value vs. 47 percent).\n\nVeracyte 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 – meaning their nodules are not clearly benign or malignant based on traditional cytopathology evaluation. Historically, most of these patients were directed to diagnostic surgery, even though 70 percent to 80 percent of the time, the nodules proved t...