Informing Decisions, Improving Outcomes

Improves outcomes by guiding personalized, risk-aligned management decisions

DecisionDx-Melanoma is a gene expression profile test that provides comprehensive, personalized results to guide risk-aligned management decisions for patients with stage I-III cutaneous melanoma. By harnessing the genetic information within a patient’s tumor biology and incorporating traditional clinicopathologic features, DecisionDx-Melanoma helps to stratify patient risk and provide personalized results regarding a patient's risk of recurrence and/or metastasis and likelihood of sentinel lymph node positivity. DecisionDx-Melanoma can help to improve prognostic accuracy, better inform management decisions and positively impact outcomes – it is the only melanoma prognostic test associated with improved survival. 

The largest real-world study of gene expression profile testing in melanoma

Recent data from an ongoing collaboration with the National Cancer Institute’s (NCI) Surveillance, Epidemiology and End Results (SEER) Program Registries show that testing with DecisionDx-Melanoma was associated with lower melanoma-specific and overall mortality relative to untested patients. In the study, DecisionDx-Melanoma provided significant and independent risk stratification of patients with cutaneous melanoma, beyond American Joint Committee on Cancer Eighth Edition (AJCC8) stage, which may help inform more personalized patient management decisions (Bailey et al, 2023).

29% Lower 3-year melanoma-specific mortality rate in patients clinically tested vs. untested 17% Lower 3-year overall mortality rate in patients clinically tested vs. untested

Comprehensive results, integrating clinicopathologic features with GEP, to inform clinical management decisions

DecisionDx-Melanoma integrates a patient’s tumor biology and clinicopathologic features to provide precise risk prediction to answer two key clinical questions – the likelihood of sentinel lymph node positivity and risk of recurrence. These personalized results help to better inform management decisions. 



 

Personalized risk of sentinel lymph node positivity

Sentinel lymph node biopsy (SLNB) is used to identify patients whose cutaneous melanoma has progressed (i.e., spread to a nearby lymph node), and who are therefore in need of additional therapeutic intervention.

The 31-GEP score is integrated with a patient’s clinicopathologic factors including Breslow thickness, ulceration, mitotic rate, and age to provide an individualized risk of sentinel lymph node (SLN) positivity.

This personalized result helps physicians make management decisions, including patients with <5% risk who may be able to safely forego SLNB.

Personalized risk of recurrence 

DecisionDx-Melanoma provides a personalized risk of recurrence for melanoma-specific survival, recurrence-free survival, and distant metastasis-free survival. (MSS, RFS, DMFS)

The 31-GEP score is now integrated with a patient’s clinicopathologic factors including Breslow thickness, ulceration, mitotic rate, SLN status, age, and tumor location to provide an individualized risk of tumor recurrence.

This personalized result helps physicians make management decisions, including clinic visits, specialist referrals, and treatment. 
 

DecisionDx-Melanoma provides more specific, personalized, risk estimates compared to staging alone

AJCC staging alone suggests a 98% survival rate for Stage I melanoma. Combined with DecisionDx class 1A results, the survival rate is 99.7%. Combine with DecisionDx class 2B results, the survival rate is 92.8%.

AJCC staging alone suggests a 90% survival rate for Stage II melanoma. Combined with DecisionDx class 1A results, the survival rate is 97.1%. Combine with DecisionDx class 2B results, the survival rate is 87.8%.

AJCC staging alone suggests a 77% survival rate for Stage III melanoma. Combined with DecisionDx class 1A results, the survival rate is 94.7%. Combine with DecisionDx class 2B results, the survival rate is 62.7%.

Guides risk-aligned patient management

Across various studies, patients tested with DecisionDx-Melanoma have been shown to have better outcomes than those who are not tested. This is likely due to changes in management based on the additional prognostic information DecisionDx-Melanoma testing provides. In fact, 1 in 2 patients tested had changes in their management plans including frequency of follow-up, lab work and surveillance monitoring. (Dillon et al, 2022)

Changes in risk-aligned management included lab work, imaging and clinic visits. 79% of changes resulted in increased management intensity for higher risk patients and 76% of changes resulted in decreased management intensity for lower risk patients.

(Dillon et al, 2022)

DecisionDx-Melanoma has demonstrated clinical impact and utility.

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