Limitations of
Melanoma Staging

Staging-Only Approach Misses Patients With Aggressive Tumor Biology

There are an estimated 130,000 patients diagnosed with invasive, non-metastatic cutaneous melanoma annually in the US. Most of these patients (estimated to be more than 100,000) are diagnosed with early stage (Stage I-II) disease. Despite recent advances in treatment, the majority of deaths still occur in patients initially diagnosed with early stage disease.

Importantly, newer therapies and regional interventions have shown effectiveness in the adjuvant setting. Early intervention is consistently shown to be a significant predictor of response to therapy (Poklepovic 2018).

Risk of Recurrence Drives Melanoma Management Decisions

Despite recent advances in melanoma treatment, a substantial percentage of early-stage melanoma patients develop metastases. In current practice, patient management decisions are based on assessment of a patient's risk of recurrence, but current anatomic/pathologic staging often falls short in identifying patients at risk for metastasis or death. In fact, among the group of patients diagnosed with localized or regional disease (Stage I-III), patients with localized disease (Stage I-II) account for 60% of those who die from melanoma.

The DecisionDx®-Melanoma test is being used broadly today by providing information based on tumor biology that is not available using current staging or traditional prognostic methods. Incorporation of this information helps to inform management decisions such as surveillance, follow-up frequency, referrals, and SLNB patient selection.