# DecisionDx-Melanoma

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

## TL;DR

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.

## Fields

- Kind: Test
- Status: established
- Last checked: 2026-11-04
- Also known as: 31-GEP; 31-gene expression profile
- Tags: test; rna
- 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.

## Sources

- Castle Biosciences: DecisionDx-Melanoma: https://www.castlebiosciences.com/tests/prognostic/decisiondx-melanoma/how-it-works
- CMS LCD L37725: MolDX: Melanoma Risk Stratification Molecular Testing: https://www.cms.gov/medicare-coverage-database/view/lcd.aspx?lcdid=37725

## Connected records

- cancers: [Melanoma](https://onco.cc/cancers/melanoma/)
- technologies: [Gene-expression prognostic assays](https://onco.cc/technologies/gene-expression-prognostic-assays/)
- companies: [Castle Biosciences](https://onco.cc/companies/castle-biosciences/)
- key papers: [Development of a prognostic genetic signature to predict the metastatic risk associated with cutaneous melanoma](https://onco.cc/key-papers/paper-gerami-melanoma-gene-expression-profile-clin-cancer-res-2015/)

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