Castle Biosciences’ DecisionDx‑Melanoma test has earned Breakthrough Device designation from the U.S. Food and Drug Administration as of July 23, 2025—a highly selective status granted to medical tools that offer significant advantages over current standards in diagnosing or treating serious conditions.
This designation fast-tracks the test through development and review processes, enabling quicker U.S. market access. The FDA reserves this for devices addressing life-threatening or irreversibly debilitating conditions—melanoma included. Castle plans to file a full marketing submission soon, supported by promising clinical data.
The DecisionDx‑Melanoma test analyzes the expression of 31 genes in a patient’s tumor tissue. It then integrates that gene expression data with clinical and pathologic information using Castle’s proprietary algorithm to generate personalized risk assessments. These assessments offer insight into the likelihood of sentinel lymph node (SLN) positivity, as well as the potential for recurrence or metastasis. This method gives dermatologists a more precise tool for assessing patient risk, moving beyond traditional staging models.
A key factor behind the FDA’s designation is the volume and strength of clinical data supporting the test. A recent study published in Cancer Diagnosis & Prognosis showed that the DecisionDx‑Melanoma test identified a subset of early-stage patients with only a 2.8% chance of SLN positivity—well below the 5% threshold set by the National Comprehensive Cancer Network for omitting SLN biopsy. In contrast, the older CP‑GEP model flagged a higher 6.2% positivity rate in the same patient group.
Additional findings from the prospective DECIDE trial revealed that use of the test led to a 25–33% reduction in unnecessary SLN biopsies, without a corresponding rise in missed metastatic cases. Moreover, real-world data covering over 13,500 patients indicated a 32% reduction in melanoma-specific mortality for those tested with DecisionDx‑Melanoma compared to untested peers.
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These results carry particular significance for women. SLN biopsy, while an important diagnostic procedure, comes with risks including pain, infection, scarring, and the possibility of lymphedema. Many early-stage melanoma patients—particularly women under 50, a group where rates have been climbing—undergo the biopsy only to learn their lymph nodes were cancer-free. A precise test that confidently identifies low-risk cases could help many women avoid the trauma and risks associated with unnecessary surgery.
In addition to reducing physical burdens, the test empowers women with clearer, evidence-based decisions about their treatment paths. For those flagged as low-risk, active monitoring may be sufficient, while those identified as high-risk can pursue more aggressive care early. That kind of personalization is at the heart of modern oncology—and aligns with broader trends in patient-centered medicine.
Looking ahead, Castle Biosciences is preparing its full marketing submission to the FDA, with hopes of obtaining final approval within the year. Dermatologists expect clinical adoption to expand rapidly, especially as more institutions integrate genomic testing into standard melanoma care protocols. The test is already in use, but FDA approval will likely lead to greater insurance reimbursement and wider clinician confidence.
For women diagnosed with early-stage melanoma, this could mean a turning point in care—offering a pathway to accurate, less invasive, and more personalized treatment decisions. With skin cancer rates still rising, innovations like DecisionDx‑Melanoma provide a timely and much-needed advancement in how the disease is managed from the very start.
