Castle Biosciences Presents Expanded Data Supporting Use of DecisionDx-Melanoma Test to Inform Sentinel Lymph Node Biopsy Recommendations

Published

Data was presented during the 16th International Congress of the Society for Melanoma Research

FRIENDSWOOD, Texas--(BUSINESS WIRE)-- Castle Biosciences, Inc. (Nasdaq: CSTL), a skin cancer diagnostics company providing personalized genomic information to improve cancer treatment decisions, today announced the presentation of data from an expanded, multi-center, prospectively tested patient cohort study supporting clinical use of the DecisionDx®-Melanoma test to inform discussions and recommendations regarding sentinel lymph node biopsy (SLNB), as well as data from a separate multi-center prospective outcomes study.

The poster titled, “Identification of melanoma patients with low risk of sentinel lymph node positivity and favorable prognosis using a 31-gene expression profile (GEP) test,” was presented during the 16th International Congress of the Society for Melanoma Research in Salt Lake City, Utah.

The data supports the clinical use of DecisionDx-Melanoma test results in combination with clinicopathologic factors to identify patients at low risk of sentinel lymph node (SLN) positivity and that T1-T2 patients identified as low risk by the DecisionDx-Melanoma test had high survival rates. This information can inform patient discussions and recommendations regarding the SLNB surgical procedure in line with national melanoma clinical practice guidelines.

Study Background:

  • National cancer guidelines recommend the SLNB surgical procedure to assess prognosis of melanoma patients whose tumor features suggest at least a 5% likelihood of sentinel lymph node (SLN) positivity. The guidelines do not recommend the procedure if a patient has a likelihood of SLN positivity of less than 5%.
  • Among all patients with T1-T2 melanoma (tumor depth of 2 mm or less), only 5-10% have a positive SLNB, with the likelihood of a positive SLN decreasing with age.
  • The DecisionDx-Melanoma test is a 31-gene expression profile prognostic test for cutaneous melanoma that predicts 5-year risk of metastasis as low risk (Class 1, 1A lowest risk) or high risk (Class 2, 2B highest risk), as well as metastasis to the sentinel lymph node.
  • The DecisionDx-Melanoma test has been previously validated to identify patients with T1-T2 melanoma with SLN positivity rates below 5%, thus helping guide SLNB discussions and recommendations.
  • This study was designed to further evaluate the ability of the DecisionDx-Melanoma test to identify T1-T2 melanoma patients with low risk for a positive SLN, using the combination of the previously published cohort with a novel cohort, totaling 1,905 prospectively tested consecutive T1-T2 melanoma patients. The cohort had a median age of 64 years, median Breslow depth of 1.2 millimeters and 13% had ulceration present.

Key Findings

In the expanded, multi-center prospectively tested patient cohort study:

  • In SLNB-assessed patients 65 years of age or older with T1-T2 tumors and a Class 1A test result, SLN positivity was 2.7%, significantly less than patients with a Class 1B-2A (p

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