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Castle Biosciences seeks crosswalk for 487-gene ADTX atopic dermatitis test to existing psoriasis GEP code

CMS Clinical Diagnostic Laboratory Test (CDLT) Panel · July 10, 2026
AI-Generated Content: All content on this page was generated by AI to highlight key points from the meeting. For complete details and context, we recommend watching the full video. so we can fix them.

Summary

Castle Biosciences told the CMS panel its 487-gene skin-surface RNA expression profile (0635U) should be crosswalked to code 0258U used for psoriasis mRNA gene-expression profiling, arguing methods and clinical utility align despite higher gene count.

Matthew Goldberg, senior vice president of medical at Castle Biosciences, presented ADTX (0635U), a 487-gene expression profile derived from noninvasive skin scrapings intended to guide systemic therapy selection for moderate-to-severe atopic dermatitis, and recommended a crosswalk to 0258U.

Goldberg said both tests use next-generation sequencing–driven gene expression profiling on noninvasive skin samples, apply proprietary algorithms that report likely therapy responders, and serve the same clinical purpose of guiding systemic therapy selection in inflammatory skin disease. Panelists questioned the gene-count discrepancy—0258U covers 50–100 genes while ADTX covers 487—and asked whether the larger panel requires materially greater laboratory resources. Goldberg responded that the tests share NGS workflows and that the analytic content of the algorithm (gene count) does not necessarily scale with per-sample resource burden.

Why it matters: The panel must decide whether to use an existing CPT/PLA crosswalk or allow a separate payment based on differing resource use. The gene-count issue was central: panelists asked for material and sequencing-resource comparisons to evaluate whether the crosswalk is appropriate.

The presenter offered to provide further clarification in writing and the panel requested any additional substantiating materials to support a crosswalk recommendation.