{"entity":{"id":"decisiondx-melanoma","kind":"drug","name":"DecisionDx-Melanoma","aka":["31-GEP","31-gene expression profile"],"tldr":"A tissue test for stage I to III skin melanoma that measures 31 genes to estimate the chance of the melanoma spreading.","summary":"Castle Biosciences states that the test \"quantifies the expression of 31 genes\" using RT-PCR \"for patients with stage I-III cutaneous melanoma\". The development study of a 28-gene signature reported disease-free survival of 97 per cent for class 1 and 31 per cent for class 2 in its validation set (Gerami 2015). Medicare's Palmetto MolDX policy L37725 covers melanoma risk-stratification tests when all its conditions are met, including stage T1b and above, or T1a with documented concern about the adequacy of microstaging; the policy text does not name the product.","status":"established","asOf":"2026-11-04","links":[{"label":"Castle Biosciences: DecisionDx-Melanoma","url":"https://www.castlebiosciences.com/tests/prognostic/decisiondx-melanoma/how-it-works"},{"label":"CMS LCD L37725: MolDX: Melanoma Risk Stratification Molecular Testing","url":"https://www.cms.gov/medicare-coverage-database/view/lcd.aspx?lcdid=37725"}],"tags":["test","rna"],"related":[],"cancers":["melanoma"],"sections":[],"technologies":["gene-expression-prognostic-assays"],"targets":[],"drugs":[],"companies":["castle-biosciences"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":["paper-gerami-melanoma-gene-expression-profile-clin-cancer-res-2015"],"journals":[],"dependsOn":[],"notes":[],"brand":"DecisionDx-Melanoma","modality":"Gene-expression prognostic assay (31-gene RT-PCR, cutaneous melanoma)","mechanism":"Reverse-transcription PCR of 28 discriminating and 3 control genes in the primary melanoma assigns a class for the risk of recurrence or spread.","approvals":[],"mechanismSteps":[],"toxicity":[],"access":[{"country":"US","reimbursement":"Medicare (Palmetto MolDX, L37725) covers melanoma risk-stratification molecular tests for cutaneous melanoma of stage T1b and above, or T1a with concern about microstaging, when all its conditions are met","source":"https://www.cms.gov/medicare-coverage-database/view/lcd.aspx?lcdid=37725","asOf":"2026-11-04"}],"regulatoryEvents":[]},"route":"/drugs/decisiondx-melanoma/","neighbours":{"cancer":[{"id":"melanoma","kind":"cancer","name":"Melanoma","route":"/cancers/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-gerami-melanoma-gene-expression-profile-clin-cancer-res-2015","kind":"paper","name":"Development of a prognostic genetic signature to predict the metastatic risk associated with cutaneous melanoma","route":"/key-papers/paper-gerami-melanoma-gene-expression-profile-clin-cancer-res-2015/"}]}}