Castle’s DecisionDx-Melanoma test is one of the company’s most in-demand products, having of September this year, 27,336 reports had been delivered. Image credit: Pressmaster / Shutterstock.

Castle Biosciences has released data from a multicenter DECIDE study showing the impact of integrating its DecisionDx-Melanoma test results into clinical decision-making in melanoma patients.

The test results can be used to determine the necessity of administering sentinel lymph node biopsy (SNLB) at the time of melanoma diagnosis to identify the spread of metastasis. DecisionDx-Melanoma test can accurately identify patients with a low risk of metastasis who can safely forgo SLNB.

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Melanoma is a type of skin cancer, and is the 17th most common type of cancer overall, according to the World Health Organization (WHO). An NIH review showed that although SNLB is necessary for staging the cancer, the high cost and invasiveness of the surgical cost should be kept in mind while determining the need for the procedure, as it can be unnecessary in patients at low risk of developing metastasis. Castle noted that the SNLB procedure showed a negative result for metastasis in approximately 88% of patients.

The prospective multicentre DECIDE trial enrolled 471 patients with melanoma whose decision to pursue or forgo SLNB surgery was informed by DecisionDx-Melanoma test results. The study showed that integrating DecisionDx-Melanoma test results into SLNB decisions resulted in 25% fewer SLNBs performed compared to a matched patient cohort.

Furthermore, no patients with a DecisionDx-Melanoma-predicted risk of SLN positivity of less than 5% who decided to forgo the test result and pursue SNLB had a positive SNLB result. Additionally, 9.8% of the patients with a DecisionDx-Melanoma-predicted risk of SLN positivity of more than 5% had a positive SLN result.

DecisionDx-Melanoma is a gene expression profile risk stratification test. It uses a validated algorithm along with clinical and pathological factors to predict and stratify the risk of SLN positivity. It is one of Castle’s most in-demand products. The company noted that it delivered 27,336 DecisionDx-Melanoma test reports in the nine months ended September 30, 2024. Castle expects a total revenue of $320-330m for all its products in 2024.

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As per GlobalData’s Clinical Trials Database, there are currently 1,490 active clinical trials for in vitro diagnostics (IVD) devices, 569 trials of these are oncology diagnostic devices. The global market for cancer diagnostic tests is expected to be worth $239.23bn in 2025.