Since its introduction in 2013, DecisionDx-Melanoma has addressed the need for a more accurate predictor of metastatic risk in patients diagnosed with early stage cutaneous (skin) melanoma.
Traditional Approaches May Have Limitations
Prior to the introduction of DecisionDx-Melanoma, nearly all treatment plan decisions made around the time of diagnosis relied solely upon traditional clinical and pathologic prognostic factors, including whether to perform the invasive sentinel lymph node (SLN) biopsy surgical procedure to see whether cancer cells were found in lymph nodes.
However, the clinical and pathology factors that lead physicians to recommend SLNB surgery have limitations. In fact, approximately 88% of patients who undergo the SLNB surgery are found to have an SLN-negative biopsy result, meaning they remain categorized as lower risk (Stage I or II). Unfortunately, despite being classified as low risk, two out of three patients who develop metastatic disease and die from their primary melanoma tumor were initially classified as Stage I or II, many of whom received an SLN-negative biopsy result following SLNB surgery. We saw an opportunity to improve care by adding personalized genomic information to address this situation. We believed that understanding the biological behavior of a patient’s tumor using the latest molecular diagnostic techniques would enable improvement over traditional clinical and pathologic factors.
Designed To Identify Risk of Recurrence or Metastasis
DecisionDx-Melanoma, our gene expression profile (GEP) test was designed to identify the risk of recurrence or metastasis in Stage I, II and III melanoma based on the biologic profile of 31 genes within their tumor tissue. There are now 22 peer-reviewed publications and additional studies involving over 3,700 patients that demonstrate a high level of consistency and demonstrate a change in treatment plans in every one of two patients tested.
Today, the test is used to guide two treatment plan decisions that are made around the time of diagnosis:
- Whether to perform a sentinel lymph node biopsy surgical procedure for eligible patients 55 years of age and older who have tumors less than 2 mm deep (T1-T2), and then
- Deciding what level of follow-up, imaging, and referrals are appropriate for any patient with a tumor at least 0.3 mm deep
DecisionDx-Melanoma is performed on formalin-fixed, paraffin embedded (FFPE) primary tumor tissue from either a biopsy or excision.