On October 16, 2020 Castle Biosciences, Inc. (Nasdaq: CSTL), a skin cancer diagnostics company providing personalized genomic information to improve cancer treatment decisions, reported the presentation of data demonstrating that DecisionDx-Melanoma identifies patients with T1-T2 melanoma who have a low risk of sentinel lymph node (SLN) positivity (Press release, Castle Biosciences, OCT 16, 2020, View Source [SID1234568581]). DecisionDx-Melanoma is Castle’s gene expression profile test that uses an individual patient’s tumor biology to predict individual risk of cutaneous melanoma metastasis or recurrence, as well as SLN positivity. The findings were highlighted in a poster presentation at the 16th European Association of Dermato-Oncology (EADO) Congress, being held virtually Oct.12-14, 2020.

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"Only 12% of patients who undergo sentinel lymph node biopsy surgery (SLNB) have a positive result," said Bob Cook, Ph.D., senior vice president of research and development at Castle Biosciences and lead author on the study. "While the likelihood of SLN-positivity decreases with age, the risk of death from melanoma increases. Our study findings demonstrate that DecisionDx-Melanoma, combined with T stage, can help identify patients 65 years of age and older with a low probability of SLN-positivity. Therefore, DecisionDx-Melanoma can provide clinicians and patients with additional, objective data and help inform decisions on SLNB surgery, helping avoid unnecessary procedures and potentially reducing healthcare costs."

The study’s objective was to incorporate DecisionDx-Melanoma with clinical features to identify patients with T1-T2 melanoma likely to have low SLN-positivity rates. The poster, entitled "Identification of patients with T1-T2 melanoma and low risk of sentinel lymph node positivity using a 31-gene expression profile test," highlights the use of DecisionDx-Melanoma in combination with clinical features. The SLN status of 2,303 patients diagnosed with T1-T2 melanoma were analyzed, and DecisionDx-Melanoma was used to stratify patient risk into low (Class 1A), intermediate (Class 1B/2A) and high (Class 2B) risk.

Key findings include:

For patients 65 years of age or older with T1-T2 tumors (n = 1,047), a positive SLN was observed in only 1.8% (95% CI 0.9-3.1) of clinically and pathologically assessed patients identified as lowest risk (Class 1A) by DecisionDx-Melanoma, versus 14.6% (95% CI 9.0-21.9) of patients identified as high risk (Class 2B).
Class 1A results were associated with higher rates of 3-year overall survival and metastasis-free survival.
Medicare Administrative Contractor, Palmetto GBA MolDx, recently issued a final expanded local coverage determination for DecisionDx-Melanoma, expanding Medicare coverage for the test in cutaneous melanoma.

About DecisionDx-Melanoma

DecisionDx-Melanoma is a gene expression profile test that uses an individual patient’s tumor biology to predict individual risk of cutaneous melanoma metastasis or recurrence, as well as sentinel lymph node positivity, independent of traditional staging factors, and has been studied in more than 5,700 patient samples. Using tissue from the primary melanoma, the test measures the expression of 31 genes. The test has been validated in four archival risk of recurrence studies of 901 patients and six prospective risk of recurrence studies including more than 1,600 patients. Prediction of the likelihood of sentinel lymph node positivity has also been validated in two prospective multicenter studies that included more than 3,000 patients. Impact on patient management plans for one of every two patients tested has been demonstrated in four multicenter and single-center studies including more than 560 patients. The consistent performance and accuracy demonstrated in these studies provides confidence in disease management plans that incorporate DecisionDx-Melanoma test results. Through June 30, 2020, DecisionDx-Melanoma has been ordered more than 59,900 times for use in patients with cutaneous melanoma.