DecisionDx-Melanoma | Castle Biosciences

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.

Addresses melanoma staging contradictions

Patients diagnosed with the same stage of melanoma can have very different tumor biology, and therefore, very different risks for developing recurrence and metastases. Traditional staging can fail to identify patients with aggressive tumor biology – misidentifying patients who have high-risk tumor biology as lower risk at the time of diagnosis. DecisionDx-Melanoma provides personalized prognostic information, guiding individualized management care decisions, such as increased surveillance, which have been shown to lead to earlier detection and, in turn, improved outcomes.

>90%

Greater than 90%

of patients who are diagnosed with melanoma are initially diagnosed with Stage I or Stage II disease and are considered to have lower-risk disease (SEER program database released April 2022).
>60%

More than 60%

of the deaths caused by melanoma (excluding Stage IV) occur in patients who were originally diagnosed at lower risk (Stage I + II) (SEER program database released April 2022).
2x

2x as likely to survive

Based on a recent study, patients were found to be twice as likely to survive if they had asymptomatic recurrence detected, compared to those who had symptoms at the time their recurrence was detected (Ibrahim et al. Ann Surg Oncol 2020).

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.

DecisionDx-Melanoma featured studies

1

Independent performance cohort

The results of this study demonstrate that DecisionDx-Melanoma can allow for more precise and personalized management of melanoma patients, improving patient selection for the SLNB surgical procedure and reducing unnecessary procedures and their associated healthcare costs. Moreover, the data provide evidence that DecisionDx-Melanoma can identify patients with a low risk of SLN positivity who may safely forego SLNB, as well as those with a higher risk who may want to consider the surgery.

Read more
2

Real World Data for DecisionDx-Melanoma
In this study, in collaboration with the National Cancer Institute’s SEER Program Registries, a group of tested patients (n=3,258) was matched to a group of patients who did not receive DecisionDx-Melanoma test results as part of their clinical care (n=9,774).

In the study, DecisionDx-Melanoma:
- Independently risk-stratified patients according to their risk of dying from melanoma, consistent with previously published retrospective and prospective studies.
- Was an independent predictor of patient outcomes.
- Testing was associated with a 29% lower melanoma-specific mortality (HR=0.71, 95% CI 0.53-0.94) and a 17% lower overall mortality (HR=0.83, 95% CI 0.70-0.99) relative to patients who did not receive DecisionDx-Melanoma testing.
Read More
3

Independent multi-center study of SLN negative patients

The study explored the utility of routine imaging to detect metastases in patients with a negative sentinel lymph node biopsy, but high-risk DecisionDx-Melanoma results, compared to patients without testing and imaging driven by current guidelines. The study found that routine surveillance imaging in SLN negative, high-risk patients detected melanoma recurrence ~10 months earlier than those without routine imaging and that patients tested had better overall survival than those not tested.

Read More