{"entity":{"id":"afirma","kind":"drug","name":"Afirma Genomic Sequencing Classifier","aka":[],"tldr":"A gene test on the needle sample from a thyroid lump that can safely call an 'uncertain' result benign and spare an operation.","summary":"Afirma (Veracyte) was the first molecular test to change thyroid practice: the original Gene Expression Classifier (2011) and the Genomic Sequencing Classifier that replaced it in 2017 are used on Bethesda III and IV nodules, where cytology is indeterminate and 20-30% of nodules prove malignant at surgery. In the blinded multicentre validation of the GSC (JAMA Surgery 2018) sensitivity was 91% and specificity 68%, giving a negative predictive value around 96%, so about half of indeterminate nodules can be observed rather than removed. It is a laboratory-developed test covered by Medicare and most US insurers; ThyroSeq v3 is the main alternative.","status":"established","asOf":"2026-09-10","links":[{"label":"Afirma GSC validation (JAMA Surg 2018)","url":"https://doi.org/10.1001/jamasurg.2018.1153"},{"label":"Veracyte: Afirma","url":"https://www.afirma.com"}],"tags":["test"],"related":[],"cancers":["thyroid"],"sections":[],"technologies":["thyroid-fna-molecular","rna-seq"],"targets":[],"drugs":[],"companies":["veracyte"],"institutions":[],"pathways":[],"terms":["sensitivity-specificity"],"trials":[],"people":[],"bottlenecks":[],"keyPapers":["paper-patel-jama-surg"],"journals":[],"dependsOn":[],"notes":["What a result means: 'benign' by Afirma carries about the same cancer risk as a benign cytology result and can be followed with ultrasound; 'suspicious' means surgery is usually advised."],"brand":"Afirma GSC","modality":"RNA-sequencing rule-out classifier test (indeterminate thyroid nodules)","mechanism":"Whole-transcriptome RNA sequencing of a fine-needle aspirate, with a machine-learned classifier trained to call cytologically indeterminate nodules benign or suspicious, plus reporting of BRAF, RET and other variants.","approvals":[],"mechanismSteps":[],"toxicity":[],"access":[],"regulatoryEvents":[]},"route":"/drugs/afirma/","neighbours":{"cancer":[{"id":"thyroid","kind":"cancer","name":"Thyroid cancer","route":"/cancers/thyroid/"}],"technology":[{"id":"rna-seq","kind":"technology","name":"RNA sequencing & expression profiling","route":"/technologies/rna-seq/"},{"id":"thyroid-fna-molecular","kind":"technology","name":"Thyroid nodule FNA, Bethesda cytology & molecular classifiers","route":"/technologies/thyroid-fna-molecular/"}],"company":[{"id":"veracyte","kind":"company","name":"Veracyte (Decipher)","route":"/companies/veracyte/"}],"term":[{"id":"sensitivity-specificity","kind":"term","name":"Sensitivity and specificity","route":"/terms/sensitivity-specificity/"}],"paper":[{"id":"paper-patel-jama-surg","kind":"paper","name":"Performance of a Genomic Sequencing Classifier for the Preoperative Diagnosis of Cytologically Indeterminate Thyroid Nodules","route":"/key-papers/paper-patel-jama-surg/"}]}}