On April 25, 2023 Castle Biosciences, Inc. (Nasdaq: CSTL), a company improving health through innovative tests that guide patient care, reported new data showing DecisionDx-Melanoma can improve risk stratification over American Joint Committee on Cancer (AJCC) staging alone in patients with stage I cutaneous melanoma (CM) (Press release, Castle Biosciences, APR 25, 2023, View Source [SID1234630503]). DecisionDx-Melanoma uses a patient’s tumor biology to provide the patient’s personalized risk of recurrence and metastasis, while AJCC staging is based on the clinical and pathologic risk factors of a patient’s melanoma tumor.

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"Patients with stage I cutaneous melanoma are considered to have a lower risk of recurrence and melanoma-specific mortality; however, due to the large number of patients diagnosed with stage I disease, this patient group accounts for the largest number of deaths from melanoma," said Sebastian Podlipnik, M.D., Department of Dermatology, Hospital Clinic of Barcelona, Spain. "As the study showed, DecisionDx-Melanoma provides more precise risk stratification over staging alone to better predict which patients have a low risk of experiencing a poor outcome and those with more aggressive tumor biology who may benefit from increased clinical surveillance."

The data were presented at the 19th European Association of Dermato-Oncology (EADO) Congress, held in Rome, Italy, in a poster titled, "The 31-gene expression profile outperforms AJCC in stratifying risk of recurrence in patients with stage I cutaneous melanoma." In the study, DecisionDx-Melanoma provided significant and independent risk stratification of patients with stage I CM. Additionally, as reported in the study, the test added valuable prognostic information to AJCC staging to better stratify recurrence-free survival (RFS) and melanoma-specific survival (MSS) among patients with stage I CM.

RFS

AJCC staging

Risk-stratification according to AJCC staging provided low-risk stage IA vs. high-risk stage IB RFS rates of 93.3% vs. 87.6%.

DecisionDx-Melanoma

DecisionDx-Melanoma demonstrated improved risk-stratification of RFS with low-risk Class 1A vs. high-risk Class 2B RFS rates of 97.3% vs. 77.3%.

MSS

AJCC staging

Risk-stratification according to AJCC staging provided low-risk stage IA vs. high-risk stage IB MSS rates of 97.6% vs. 97.9%.

DecisionDx-Melanoma

DecisionDx-Melanoma demonstrated improved risk-stratification of MSS with low-risk Class 1A vs. high-risk Class 2B MSS rates of 98.0% vs. 92.3%.

Importantly, the data demonstrate that patients with AJCC stage I CM who had a high-risk (Class 2B) DecisionDx-Melanoma test result were 5.4 times more likely to die from melanoma compared to patients staged as IB according to AJCC staging. The results of the study support the use of DecisionDx-Melanoma to guide better risk-aligned care in patients considered low risk by staging by identifying high-risk patients who may be missed using only AJCC staging criteria.

About DecisionDx-Melanoma

DecisionDx-Melanoma is a gene expression profile risk stratification test. It is designed to inform two clinical questions in the management of cutaneous melanoma: a patient’s individual risk of sentinel lymph node (SLN) positivity and a patient’s personal risk of melanoma recurrence and/or metastasis. By integrating tumor biology with clinical and pathologic factors using a validated proprietary algorithm, DecisionDx-Melanoma is designed to provide a comprehensive and clinically actionable result to guide risk-aligned patient care. DecisionDx-Melanoma has been shown to be associated with improved patient survival and has been studied in more than 10,000 patient samples. DecisionDx-Melanoma’s clinical value is supported by more than 40 peer-reviewed and published studies, providing confidence in disease management plans that incorporate the test’s results. Through Dec. 31, 2022, DecisionDx-Melanoma has been ordered 120,287 times for patients diagnosed with cutaneous melanoma. More information about the test and disease can be found at www.CastleTestInfo.com.