AT A GLANCE

Castle Biosciences’ DecisionDx®-Melanoma test—a gene expression profile (GEP) assay designed to predict sentinel lymph node positivity and risk of metastasis in patients with stage I–III cutaneous melanoma—has received Breakthrough Device designation from the FDA. This recognition signals growing regulatory interest in biomarker-driven tools that offer more personalized and precise cancer risk stratification.

Unlike traditional staging systems that rely heavily on clinical and histopathologic features, DecisionDx-Melanoma uses a proprietary algorithm to integrate tumor biology with established clinical data, yielding a personalized risk profile for recurrence and metastasis. In research settings, the test has shown strong predictive performance, validated in more than 10,000 patient samples and over 50 peer-reviewed studies.

The FDA’s Breakthrough Devices Program aims to accelerate access to promising technologies for life-threatening conditions. By designating DecisionDx-Melanoma as such, the agency is acknowledging the test’s potential to shift the paradigm in early-stage melanoma management—particularly by informing surgical and surveillance decisions based on individualized biological risk rather than population-level data alone.

Castle Biosciences has indicated plans to pursue full marketing authorization and anticipates closer collaboration with the FDA during this process. 

“We believe this recognition by the FDA supports DecisionDx-Melanoma's potential to significantly improve melanoma outcomes by delivering personalized care to those who need it most," said Derek Maetzold, president and chief executive officer of Castle Biosciences in a press release. "We expect to submit a device marketing submission to the FDA and look forward to working with the agency to help more patients access these potentially life-changing insights.”

If cleared, the test could become a key decision-support tool in the ongoing effort to align melanoma treatment with biologic behavior and improve outcomes through more targeted interventions.