On July 9, 2020 Castle Biosciences, Inc. (Nasdaq: CSTL), a skin cancer diagnostics company providing personalized genomic information to improve cancer treatment decisions, reported the publication of an independent, systematic review and meta-analysis demonstrating that its DecisionDx-Melanoma test is a significant predictor of recurrence and metastatic risk in patients with invasive cutaneous melanoma (Press release, Castle Biosciences, JUL 9, 2020, View Source [SID1234561799]).

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The article titled, "A Systematic Review and Meta-Analysis of Gene Expression Profiling for Primary Cutaneous Melanoma Prognosis," appeared in SKIN: The Journal of Cutaneous Medicine.

The study found that of all gene expression profile tests reported for cutaneous melanoma, DecisionDx-Melanoma was the only test described in the literature or commercially available with sufficient evidence to qualify for inclusion in the study. This is the second recently published systematic review and meta-analysis that demonstrates the independence and significance of DecisionDx-Melanoma prognosis for recurrence and metastatic risk in patients with invasive cutaneous melanoma.

Lichtman et al. Study Background and Results:

The purpose of this systematic review and meta-analysis was to consolidate the rapidly evolving body of data on gene expression profiling (GEP) in melanoma prognosis.
This study was performed according to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA)1.
The systematic review identified several GEP assays that have been described in the literature. However, aside from DecisionDx-Melanoma, none of the reported studies were supported by consistent reporting of results or enough evidence for inclusion in the meta-analysis performed by study co-authors.
The DecisionDx-Melanoma test was found to be a consistent, independent and significant predictor of survival, with a significant association between Class 2 test results and recurrence-free (Hazard Ratio [HR] = 7.22; p <0.00001), distant metastasis-free (HR = 6.62; p <0.00001) and overall (HR = 7.06; p <0.00001) survival rates.
DecisionDx-Melanoma test results were also associated with sentinel lymph node biopsy status (odds ratio calculation; p<0.00001).
Results of the study indicate that the DecisionDx-Melanoma test achieved the highest Strength of Recommendation Taxonomy (SORT) level of evidence for a prognostic biomarker (Level 1 evidence). 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 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 March 31, 2020, DecisionDx-Melanoma has been ordered more than 56,800 times for use in patients with cutaneous melanoma.