Castle Biosciences Inc., announced the publication of a study in JCO Precision Oncology in which DecisionDx-Melanoma provided significant, independent risk stratification of patients with cutaneous melanoma (CM), beyond American Joint Committee on Cancer Eighth Edition (AJCC8) stage, which may help inform more personalized melanoma patient management decisions. Additionally, data from the study shows that testing with DecisionDx-Melanoma was associated with lower melanoma-specific and overall mortality relative to untested patients. 

“Management decisions for melanoma patients, such as referrals for sentinel lymph node biopsy or frequency and intensity of surveillance, are guided by a patient’s risk of disease recurrence or metastasis, and improvements in the accuracy of risk prediction can inform these decisions,” says Matthew Goldberg, MD, FAAD, board-certified dermatologist and dermatopathologist, and senior vice president, medical, of Castle Biosciences. “The independent risk-stratification provided by DecisionDx-Melanoma has already been demonstrated in numerous retrospective and prospective studies. This large study of real-world, unselected, clinically tested patients who received our test as part of their ongoing melanoma care further supports these findings.

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“The statistically significant risk stratification for survival between patients who received a Class 1A test result (lowest risk of metastasis) and those with a Class 2B test result (highest risk of metastasis) highlights the value that testing with DecisionDx-Melanoma can bring to personalizing patient care decisions when interpreted in the context of the extensive, published clinical utility data for DecisionDx-Melanoma, including the recently published study from Dhillon et al.”

In the study covering melanoma management, to assess the effect of the DecisionDx-Melanoma test on survival outcomes, a group of tested patients (n=3,258) was matched to a group of patients who did not receive DecisionDx-Melanoma test results as part of their clinical care (n=9,774); the matching was performed using propensity score matching with three untested patients for each tested patient and was based on 11 clinicopathologic and socioeconomic variables.

Key findings of the study include:

  • DecisionDx-Melanoma independently risk-stratified patients according to their risk of dying from melanoma, consistent with previously published retrospective and prospective studies.
  • DecisionDx-Melanoma was an independent predictor of patient outcomes; a Class 2B (high risk) DecisionDx-Melanoma test result was an independent predictor of melanoma-specific survival (HR= 7.00, 95% CI 2.70-18.00) and overall survival (HR= 2.39, 95% CI 1.54-3.70). Additionally, a Class 2B result conferred the highest risk of all clinicopathologic factors included in multivariable analyses that included ulceration status, Breslow thickness, and nodal status, the three risk factors used in the AJCC8 staging system.
  • DecisionDx-Melanoma testing was associated with 29% lower melanoma-specific mortality (HR=0.71, 95% CI 0.53-0.94) and 17% lower overall mortality (HR=0.83, 95% CI 0.70-0.99) relative to patients who did not receive DecisionDx Melanoma testing.

“We believe that DecisionDx-Melanoma will be a practice-changing test, providing personalized information based on the genomic profile of a patient’s tumor that can help guide more informed and risk-aligned patient care decisions,” says Derek Maetzold, president and chief executive officer of Castle Biosciences. “We are looking forward to continuing our collaboration with the NCI SEER Program’s Registries to provide DecisionDx Melanoma data to the SEER registries as part of public health reporting to further advance research and patient care.”