12 June 2019 - - Findings from a new real-world study show that US-based genomic diagnostics company Veracyte, Inc.'s (NASDAQ: VCYT) Afirma Genomic Sequencing Classifier helps to identify significantly more benign thyroid nodules and further reduce unnecessary surgeries in thyroid cancer diagnosis, as compared to the original Afirma test, the company said.
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.
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 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% more nodules as benign (76.2% vs. 48.1%) and that the rate of surgery among indeterminate thyroid nodules decreased by 66.4% (from 52.5% with the Afirma GEC to 17.6% 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% vs. 25.7%).
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.
The Afirma Genomic Sequencing Classifier and Xpression Atlas provide physicians with a comprehensive solution for a complex landscape in thyroid nodule diagnosis.
The Afirma GSC was developed with RNA whole-transcriptome sequencing and machine learning, and commercially introduced in 2017.
The test helps identify patients with benign thyroid nodules among those with indeterminate cytopathology results in order to help patients avoid unnecessary diagnostic thyroid surgery.
Clinical validation data published in JAMA Surgery show that the next-generation classifier maintains the original Afirma test's high sensitivity (91%), while identifying 30% more benign nodules (68% specificity) among those deemed indeterminate by cytopathology.
The Afirma Xpression Atlas provides physicians with genomic alteration content from the same fine needle aspiration samples that are used in Afirma GSC testing and may help physicians decide with greater confidence on the surgical or therapeutic pathway for their patients.
The Afirma Xpression Atlas includes 761 DNA variants and 130 RNA fusion partners in over 500 genes that are associated with thyroid cancer.