{"entity":{"id":"decisiondx-um","kind":"drug","name":"DecisionDx-UM","aka":["uveal melanoma gene expression profile","15-gene uveal melanoma classifier"],"tldr":"A test on a small sample of an eye melanoma that measures 15 transcripts to estimate how likely it is to spread, often to the liver.","summary":"Medicare's Palmetto MolDX policy L37033 describes DecisionDx-UM as \"an ribonucleic acid (RNA) gene expression classifier\" of \"15 mRNA transcripts (3 control and 12 discriminating genes)\" and provides \"limited coverage\" for managing newly diagnosed uveal melanoma in patients with a confirmed diagnosis and no evidence of metastatic disease. In the prospective Collaborative Ocular Oncology Group validation of 459 patients, metastasis was detected in 3 class 1 cases (1.1 per cent) and 44 class 2 cases (25.9 per cent) (Onken 2012).","status":"established","asOf":"2026-11-04","links":[{"label":"Castle Biosciences: DecisionDx-UM","url":"https://www.castlebiosciences.com/tests/prognostic/decisiondx-um/"},{"label":"CMS LCD L37033: MolDX: DecisionDx-UM (Uveal Melanoma)","url":"https://www.cms.gov/medicare-coverage-database/view/lcd.aspx?lcdid=37033"}],"tags":["test","rna"],"related":[],"cancers":["uveal-melanoma"],"sections":[],"technologies":["gene-expression-prognostic-assays"],"targets":[],"drugs":[],"companies":["castle-biosciences"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":["paper-onken-uveal-melanoma-gene-expression-coog-ophthalmology-2012"],"journals":[],"dependsOn":[],"notes":[],"brand":"DecisionDx-UM","modality":"Gene-expression prognostic assay (15 transcripts, uveal melanoma)","mechanism":"An RNA classifier of 12 discriminating and 3 control transcripts, run on fine-needle aspirate or fixed tumour tissue, assigns class 1 (lower) or class 2 (higher) risk of metastasis.","approvals":[],"mechanismSteps":[],"toxicity":[],"access":[{"country":"US","reimbursement":"Medicare (Palmetto MolDX, L37033) provides limited coverage for newly diagnosed uveal melanoma without evidence of metastatic disease","source":"https://www.cms.gov/medicare-coverage-database/view/lcd.aspx?lcdid=37033","asOf":"2026-11-04"}],"regulatoryEvents":[]},"route":"/drugs/decisiondx-um/","neighbours":{"cancer":[{"id":"uveal-melanoma","kind":"cancer","name":"Uveal melanoma","route":"/cancers/uveal-melanoma/"}],"technology":[{"id":"gene-expression-prognostic-assays","kind":"technology","name":"Gene-expression prognostic assays","route":"/technologies/gene-expression-prognostic-assays/"}],"company":[{"id":"castle-biosciences","kind":"company","name":"Castle Biosciences","route":"/companies/castle-biosciences/"}],"paper":[{"id":"paper-onken-uveal-melanoma-gene-expression-coog-ophthalmology-2012","kind":"paper","name":"Collaborative Ocular Oncology Group report number 1: prospective validation of a multi-gene prognostic assay in uveal melanoma","route":"/key-papers/paper-onken-uveal-melanoma-gene-expression-coog-ophthalmology-2012/"}]}}