{"entity":{"id":"decisiondx-scc","kind":"drug","name":"DecisionDx-SCC","aka":["40-GEP","40-gene expression profile"],"tldr":"A tissue test for high-risk squamous cell skin cancer that measures 40 genes to estimate the chance of spread; Medicare does not cover it.","summary":"Castle Biosciences describes \"a qRT-PCR assay of 6 control and 34 discriminant genes (40 in total)\" for cutaneous squamous cell carcinoma with at least one high-risk feature. In its validation, three-year metastasis-free survival was 91.4, 80.6 and 44.0 per cent for classes 1, 2A and 2B (Wysong 2021). Medicare's Palmetto MolDX policy L39583 states that \"Current molecular biomarker tests that risk stratify individuals with cutaneous squamous cell carcinoma (cSCC) are non-covered by this contractor\".","status":"emerging","asOf":"2026-11-04","links":[{"label":"Castle Biosciences: DecisionDx-SCC","url":"https://www.castlebiosciences.com/tests/prognostic/decisiondx-scc/how-it-works"},{"label":"CMS LCD L39583: MolDX: Molecular Biomarker Testing for Risk Stratification of Cutaneous Squamous Cell Carcinoma","url":"https://www.cms.gov/medicare-coverage-database/view/lcd.aspx?lcdid=39583"}],"tags":["test","rna"],"related":[],"cancers":["cutaneous-scc"],"sections":[],"technologies":["gene-expression-prognostic-assays"],"targets":[],"drugs":[],"companies":["castle-biosciences"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":["paper-wysong-40-gene-cutaneous-scc-j-am-acad-dermatol-2021"],"journals":[],"dependsOn":[],"notes":[],"brand":"DecisionDx-SCC","modality":"Gene-expression prognostic assay (40-gene RT-PCR, cutaneous squamous cell carcinoma)","mechanism":"Quantitative RT-PCR of 34 discriminating and 6 control genes in the primary tumour assigns class 1, 2A or 2B risk of metastasis.","approvals":[],"mechanismSteps":[],"toxicity":[],"access":[{"country":"US","reimbursement":"Not covered by Medicare: Palmetto MolDX policy L39583 lists molecular risk-stratification tests for cutaneous squamous cell carcinoma as non-covered","source":"https://www.cms.gov/medicare-coverage-database/view/lcd.aspx?lcdid=39583","asOf":"2026-11-04"}],"regulatoryEvents":[]},"route":"/drugs/decisiondx-scc/","neighbours":{"cancer":[{"id":"cutaneous-scc","kind":"cancer","name":"Cutaneous squamous cell carcinoma","route":"/cancers/cutaneous-scc/"}],"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-wysong-40-gene-cutaneous-scc-j-am-acad-dermatol-2021","kind":"paper","name":"Validation of a 40-gene expression profile test to predict metastatic risk in localized high-risk cutaneous squamous cell carcinoma","route":"/key-papers/paper-wysong-40-gene-cutaneous-scc-j-am-acad-dermatol-2021/"}]}}