# ThyroSeq v3 Genomic Classifier

Source: https://onco.cc/drugs/thyroseq/  
OnCo record `thyroseq` (Test). Data CC BY-NC 4.0, attribute "Data from OnCo (onco.cc)"; commercial use needs a licence.

## TL;DR

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.

## Fields

- Kind: Test
- Status: established
- Last checked: 2026-11-04
- Also known as: ThyroSeq v3; ThyroSeq GC
- Tags: test; rna
- 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.

## Sources

- ThyroSeq: about the test: https://www.thyroseq.com/about-the-test/
- CMS LCD L38968: Thyroid Nodule Molecular Testing: https://www.cms.gov/medicare-coverage-database/view/lcd.aspx?lcdid=38968
- CMS LCD L39646: MolDX: Molecular Testing for Risk Stratification of Thyroid Nodules: https://www.cms.gov/medicare-coverage-database/view/lcd.aspx?lcdid=39646

## Connected records

- drugs: [Afirma Genomic Sequencing Classifier](https://onco.cc/drugs/afirma/), [ThyGeNEXT and ThyraMIR v2](https://onco.cc/drugs/thygenext-thyramir/)
- cancers: [Thyroid cancer](https://onco.cc/cancers/thyroid/)
- technologies: [RNA sequencing & expression profiling](https://onco.cc/technologies/rna-seq/), [Thyroid nodule FNA, Bethesda cytology & molecular classifiers](https://onco.cc/technologies/thyroid-fna-molecular/)
- key papers: [Performance of a Multigene Genomic Classifier in Thyroid Nodules With Indeterminate Cytology: A Prospective Blinded Multicenter Study](https://onco.cc/key-papers/paper-steward-thyroseq-v3-indeterminate-nodules-jama-oncol-2019/)

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