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DecisionDx-Melanoma Test Reduces Unnecessary Biopsies in Melanoma Patients

• A multi-center study (DECIDE) demonstrates that integrating DecisionDx-Melanoma test results into clinical decision-making reduces the necessity for sentinel lymph node biopsies (SLNB). • The DecisionDx-Melanoma test accurately identifies melanoma patients with a low risk of metastasis, allowing them to safely forgo SLNB. • The study showed a 25% reduction in SLNB procedures when using the DecisionDx-Melanoma test, without compromising the detection of positive SLNB results. • In patients with <5% risk predicted by DecisionDx-Melanoma, forgoing SLNB resulted in no missed positive SLNB cases, highlighting the test's accuracy.

Castle Biosciences' DecisionDx-Melanoma test has demonstrated its ability to reduce the number of unnecessary sentinel lymph node biopsies (SLNB) performed in melanoma patients, according to data from the multi-center DECIDE study. The study highlights the potential of the test to refine clinical decision-making and minimize invasive procedures for patients at low risk of metastasis.

Impact on SLNB Decisions

The DecisionDx-Melanoma test is designed to assess the risk of metastasis in melanoma patients, aiding clinicians in determining whether SLNB is necessary at the time of diagnosis. SLNB, while crucial for staging melanoma, carries costs and invasiveness that can be avoided in low-risk patients. An NIH review indicates that approximately 88% of patients undergoing SLNB show negative results for metastasis, underscoring the need for better risk stratification tools.
The prospective DECIDE trial enrolled 471 melanoma patients, using DecisionDx-Melanoma test results to guide SLNB decisions. The study revealed a 25% reduction in SLNB procedures compared to a matched cohort, demonstrating the test's effectiveness in reducing unnecessary surgeries.

Accuracy and Risk Stratification

Notably, no patients with a DecisionDx-Melanoma-predicted risk of SLN positivity below 5% who chose to forgo SLNB had a positive SLNB result. Conversely, 9.8% of patients with a predicted risk above 5% showed a positive SLN result. These findings underscore the test's accuracy in identifying low-risk patients who can safely avoid SLNB.

About DecisionDx-Melanoma

DecisionDx-Melanoma is a gene expression profile test that stratifies the risk of SLN positivity using a validated algorithm, combined with clinical and pathological factors. Castle Biosciences reported delivering 27,336 DecisionDx-Melanoma test reports in the nine months leading up to September 30, 2024, and anticipates total revenue of $320m-$330m for all its products this year.

Melanoma Statistics and Market Context

Melanoma is the 17th most common cancer worldwide, according to the World Health Organization (WHO). The global market for cancer diagnostic tests is projected to reach $239.23 billion in 2025, highlighting the growing importance of accurate and efficient diagnostic tools like DecisionDx-Melanoma.
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Reference News

[1]
Castle boasts melanoma test's capacity to reduce unnecessary testing - Clinical Trials Arena
clinicaltrialsarena.com · Nov 7, 2024

Castle Biosciences' DecisionDx-Melanoma test, used to determine necessity of sentinel lymph node biopsy (SLNB) in melano...

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