{"entity":{"id":"thyroseq","kind":"drug","name":"ThyroSeq v3 Genomic Classifier","aka":["ThyroSeq v3","ThyroSeq GC"],"tldr":"A test on a thyroid nodule needle sample whose cells looked uncertain, reading DNA and RNA to say whether the nodule is likely to be cancer and spare some people surgery.","summary":"The ThyroSeq site describes \"next-generation sequencing of DNA and RNA\" across \"over 100 genes\" for \"mutations, gene fusions, copy number alterations as well as gene expression alterations\", and states that \"ThyroSeq is a laboratory-developed test (LDT) regulated under CLIA regulations, not the Food and Drug Administration.\" In a prospective blinded study of nodules with indeterminate cytology it had 94 per cent sensitivity, 82 per cent specificity and a negative predictive value of 97 per cent (Steward 2019). The Wellpoint Medicare policy L38968 names it and allows testing once per nodule work-up when all its criteria are met; the MolDX thyroid policy L39646 covers molecular risk stratification of Bethesda III and IV nodules.","status":"established","asOf":"2026-11-04","links":[{"label":"ThyroSeq: about the test","url":"https://www.thyroseq.com/about-the-test/"},{"label":"CMS LCD L38968: Thyroid Nodule Molecular Testing","url":"https://www.cms.gov/medicare-coverage-database/view/lcd.aspx?lcdid=38968"},{"label":"CMS LCD L39646: MolDX: Molecular Testing for Risk Stratification of Thyroid Nodules","url":"https://www.cms.gov/medicare-coverage-database/view/lcd.aspx?lcdid=39646"}],"tags":["test","rna"],"related":["afirma","thygenext-thyramir"],"cancers":["thyroid"],"sections":[],"technologies":["thyroid-fna-molecular","rna-seq"],"targets":[],"drugs":[],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":["paper-steward-thyroseq-v3-indeterminate-nodules-jama-oncol-2019"],"journals":[],"dependsOn":[],"notes":[],"brand":"ThyroSeq","modality":"DNA and RNA next-generation sequencing classifier (thyroid nodule aspirates)","mechanism":"Targeted sequencing of DNA and RNA from a fine-needle aspirate reads mutations, gene fusions, copy number changes and gene expression in over 100 genes and gives a probability of cancer.","approvals":[],"mechanismSteps":[],"toxicity":[],"access":[{"country":"US","reimbursement":"Medicare policy L38968 (Wellpoint) names ThyroSeq v3 for thyroid nodules with indeterminate cytology, once per nodule work-up; MolDX policy L39646 covers molecular risk stratification of Bethesda III and IV thyroid nodules","source":"https://www.cms.gov/medicare-coverage-database/view/lcd.aspx?lcdid=38968","asOf":"2026-11-04"}],"regulatoryEvents":[]},"route":"/drugs/thyroseq/","neighbours":{"drug":[{"id":"afirma","kind":"drug","name":"Afirma Genomic Sequencing Classifier","route":"/drugs/afirma/"},{"id":"thygenext-thyramir","kind":"drug","name":"ThyGeNEXT and ThyraMIR v2","route":"/drugs/thygenext-thyramir/"}],"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/"}],"paper":[{"id":"paper-steward-thyroseq-v3-indeterminate-nodules-jama-oncol-2019","kind":"paper","name":"Performance of a Multigene Genomic Classifier in Thyroid Nodules With Indeterminate Cytology: A Prospective Blinded Multicenter Study","route":"/key-papers/paper-steward-thyroseq-v3-indeterminate-nodules-jama-oncol-2019/"}]}}