Benzinga | Nov 19, 2021 07:08AM EST

Castle Biosciences Highlights Data On DecisionsDx-Melanoma Published In 'Future Oncology'

Data demonstrated that patients with a DecisionDx-Melanoma Class 1A (low risk) test result had a five-year recurrence-free survival rate and distant metastasis-free survival rate of 95.8% and 99.2%, respectively

FRIENDSWOOD, Texas--(BUSINESS WIRE)-- Castle Biosciences, Inc. (NASDAQ:CSTL), a company applying innovative diagnostics to transform disease management and improve patient outcomes, today announced the publication of a study of patients with stage I-III cutaneous melanoma. Data demonstrated that DecisionDx(r)-Melanoma is a significant independent predictor of metastatic recurrence.

DecisionDx-Melanoma is Castle's gene expression profile (GEP) test that uses an individual patient's tumor biology to predict the risk of cutaneous melanoma metastasis or recurrence, as well as the risk of sentinel lymph node (SLN) positivity, independent of traditional staging factors. The study, titled "The 31-gene expression profile stratifies recurrence and metastasis risk in patients with cutaneous melanoma," analyzed 438 patients who were tested with DecisionDx-Melanoma as part of their clinical care. The study can be accessed here.

"This study reinforced one of the primary reasons why I order DecisionDx-Melanoma for my patients as soon as they receive a melanoma diagnosis," said first author Abel Jarell, M.D., dermatologist and dermatopathologist at Northeast Dermatology Associates, Portsmouth, N.H. "It's designed to provide personalized, prognostic information that I use to determine the likelihood that the cancer will spread, which helps inform decisions for treatment to ensure the best possible outcome for each patient's disease."

Study background and highlights:

* The study's primary purpose was to show risk stratification by DecisionDx-Melanoma in patients with stage I--III cutaneous melanoma. A secondary end point was to demonstrate the added prognostic value of DecisionDx-Melanoma when combined with complete American Joint Committee on Cancer (AJCC) staging (including SLN status) or with SLN status alone, for recurrence detection.

* 438 patients with stage I--III melanoma consecutively tested with DecisionDx-Melanoma were analyzed and stratified as low risk (Class 1A), intermediate risk (Class 1B/2A) or high risk (Class 2B) of recurrence or metastasis.

* DecisionDx-Melanoma significantly stratified five-year melanoma survival prognoses for patients, including recurrence-free survival (RFS) (p<0.001), distant metastasis-free survival (DMFS) (p<0.001) and melanoma-specific survival (MSS) (p<0.001).

* Patients with a DecisionDx-Melanoma low-risk result (Class 1A) had higher five-year survival outcomes and were less likely to experience a recurrence than patients with a high-risk result (Class 2B).

* Multivariable analysis showed that DecisionDx-Melanoma is a significant, independent predictor of metastatic recurrence (hazard ratio=5.38, p=0.014).

* DecisionDx-Melanoma increased prognostic survival accuracy over sentinel lymph node status alone.

* Consistent with previous validation and performance studies, the study demonstrated that DecisionDx-Melanoma added independent prognostic value to current staging guidelines for cutaneous melanoma to identify patients with a high and low recurrence or metastasis risk to improve patient management.