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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.
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.
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.
| Country | Reimbursement | List price | Assistance |
|---|---|---|---|
| United States | 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 | not disclosed | - |
List prices are manufacturer or Medicare figures where publicly disclosed; net prices after rebates are usually lower. Reimbursement changes; check the payer.
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Query for this drug: (TITLE:"ThyroSeq v3 Genomic Classifier" OR ABSTRACT:"ThyroSeq v3 Genomic Classifier" OR TITLE:"ThyroSeq" OR ABSTRACT:"ThyroSeq" OR TITLE:"ThyroSeq v3" OR ABSTRACT:"ThyroSeq v3" OR TITLE:"ThyroSeq GC" OR ABSTRACT:"ThyroSeq GC") 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 ThyroSeq v3 Genomic Classifier, not a curated reading list.
Shares RNA sequencing & expression profiling and the tags test, rna.
Shares RNA sequencing & expression profiling and the tags test, rna.
Shares RNA sequencing & expression profiling and the tags test, rna.
Shares RNA sequencing & expression profiling and the tags test, rna.
Shares RNA sequencing & expression profiling and the tags test, rna.
Shares RNA sequencing & expression profiling and the tags test, rna.
Shares RNA sequencing & expression profiling and the tags test, rna.
Shares RNA sequencing & expression profiling and the tags test, rna.
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