On June 10, 2019 Veracyte, Inc. (Nasdaq: VCYT) reported that findings from a new real-world study show that the company’s Afirma Genomic Sequencing Classifier (GSC) helps to identify significantly more benign thyroid nodules and further reduce unnecessary surgeries in thyroid cancer diagnosis, as compared to the original Afirma test (Press release, Veracyte, JUN 10, 2019, View Source [SID1234536969]). Findings from the clinical utility study, conducted by researchers at The Ohio State University, appear online in the journal Thyroid and add to the growing body of independent evidence demonstrating the performance of the next-generation genomic test.

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In the study, researchers evaluated records for all patients whose thyroid nodules were indeterminate for cancer based on cytopathology and who subsequently underwent molecular testing with the Afirma GSC or the original Afirma Gene Expression Classifier (GEC) between February 2011 and December 2018. Based on a cohort of 164 Afirma GSC-tested nodules and 343 Afirma GEC-tested nodules, they found that the next-generation test identified 58 percent more nodules as benign (76.2 percent vs. 48.1 percent) and that the rate of surgery among indeterminate thyroid nodules decreased by 66.4 percent (from 52.5 percent with the Afirma GEC to 17.6 percent with the Afirma GSC). The "benign call" rate among Hürthle cells – a common but difficult-to-diagnose thyroid nodule subtype – was also significantly higher using the Afirma GSC (88.8 percent vs. 25.7 percent).

"Our findings show that use of the Afirma GSC has enabled us to identify many more patients as benign when their thyroid nodules were indeterminate compared to the original test and, as a result, to help significantly reduce unnecessary thyroid surgeries among these patients," said Jennifer A. Sipos, M.D., endocrinologist and professor at The Ohio State University and an author of the new study. "The next-generation test’s results were particularly striking for patients with Hürthle cells who previously had little other choice than to undergo diagnostic surgery, which carries risks and is costly."

The new study marks the third recent independent publication by a major medical center demonstrating that its use of the Afirma GSC helped to significantly reduce surgeries in thyroid cancer diagnosis.

"These findings clearly demonstrate that, as compared to our original test, our Afirma GSC is delivering even more value to patients who are undergoing evaluation for thyroid cancer, as well as to physicians and the healthcare system," said Bonnie Anderson, Veracyte’s chairman and chief executive officer. "This study further underscores the power of our next-generation RNA whole-transcriptome sequencing and machine learning platform to answer important clinical questions that help guide a patient’s medical journey."