Afirma Genomic Sequencing Classifier
A gene test on the needle sample from a thyroid lump that can safely call an 'uncertain' result benign and spare an operation.
Overview
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.
Trials
topRecruiting now (live from ClinicalTrials.gov)
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Notes
top- 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.
Latest papers
topQuery for this drug: (TITLE:"Afirma Genomic Sequencing Classifier" OR ABSTRACT:"Afirma Genomic Sequencing Classifier") AND (cancer OR tumor OR tumour OR oncology OR carcinoma OR lymphoma OR leukemia OR leukaemia OR myeloma OR sarcoma OR melanoma OR glioma). Results are unfiltered search hits about Afirma Genomic Sequencing Classifier, not a curated reading list.
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