On April 1, 2020 Castle Biosciences, Inc. (Nasdaq: CSTL), a skin cancer diagnostics company providing personalized genomic information to improve cancer treatment decisions, reported the publication of a systematic review and meta-analysis of four study cohorts demonstrating that the DecisionDx-Melanoma test is an independent, significant predictor of recurrence and metastatic risk in patients with invasive cutaneous melanoma (Press release, Castle Biosciences, APR 1, 2020, View Source [SID1234556074]).

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The article titled, "Molecular risk prediction in cutaneous melanoma: a meta-analysis of the 31-gene expression profile prognostic test in 1,479 patients," appeared in the Journal of the American Academy of Dermatology (JAAD).

"This systematic review and meta-analysis are important because they further demonstrate the strength and consistency of the DecisionDx-Melanoma test as a significant, independent predictor of recurrence and metastasis in patients with Stage I-III melanoma, across these unique study cohorts," said lead author Bradley Greenhaw, M.D., Dermatology Center of North Mississippi, Tupelo, Mississippi. "The meta-analysis shows the value of using the DecisionDx-Melanoma gene expression profile test in combination with American Joint Committee on Cancer (AJCC) staging to optimize melanoma prognostication."

Systematic Review and Meta-Analysis Background:

This study was performed according to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA)1.

Multiple published archival and prospective studies have described the prognostic capability, performance and clinical utility of the DecisionDx-Melanoma test to assess recurrence risk and inform patient management decisions on sentinel lymph node recommendations, follow up, surveillance imaging and referrals for patients with cutaneous melanoma.

This systematic review and meta-analysis were performed to evaluate the cumulative prognostic effect of the test across multiple cohorts with a focus on differences in recurrence and distant metastasis between patients with a DecisionDx-Melanoma Class 1A (lowest risk) and Class 2B (highest risk) test result. Four study cohorts, which included a total of 1,479 non-overlapping patients with Stage I-III melanoma, were included in the analysis.

Systematic Review and Meta-Analysis Results:

The DecisionDx-Melanoma test was found to be a consistent, independent and significant predictor of recurrence and metastatic risk in the meta-analysis across four study cohorts, achieving the highest Strength of Recommendation Taxonomy (SORT) level for a prognostic biomarker (Level 1 evidence).
The DecisionDx-Melanoma risk assessment is independent from other clinical factors (age, Breslow tumor thickness, ulceration and node status) and improves upon risk assessment performed with staging factors alone.
For melanoma recurrence, multivariate analysis showed that patients with DecisionDx-Melanoma Class 2B tumors are 2.90 times more likely (Hazard Ratio) to experience a recurrence than patients with Class 1A tumors (p<0.0001).
For distant metastasis, patients with Class 2B tumors are 2.75 times more likely to experience a distant metastasis than patients with Class 1A tumors (p<0.0001).
Despite differences in populations and study design, heterogeneity among the four studies was not significant.
The SORT system is used by the American Academy of Dermatology (AAD) and other organizations to evaluate the quality, quantity and consistency of evidence supporting tests such as DecisionDx-Melanoma. The SORT scale evaluates both the quality of the evidence (Level 1, 2 or 3) and strength of the recommendation (A, B or C).

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 1600 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. Since its commercial launch in 2015, through December 31, 2019, DecisionDx-Melanoma has been ordered 51,967 times for use in patients with cutaneous melanoma.

More information about the test and disease can be found at www.SkinMelanoma.com.