Castle Biosciences’ DecisionDx-Melanoma test can be used to accurately predict cancer recurrence and metastasis in patients with head and neck melanoma, the company announced.
Studies found that the accuracy of the test is even higher when used in combination with a sentinel lymph node (SLN) biopsy.
The Decision-Dx-Melanoma test is based on the analysis of the activity of 31 different genes in the tumor, called the molecular signature of the tumor.
The accuracy of the two tests was compared in the study “Prognostic Accuracy of a 31-Gene Expression Profile (GEP) in a Cohort of Patients with Cutaneous Melanoma of the Head and Neck,” presented at the American College of Mohs Surgery 49th Annual Meeting (ACMS) held April 27-30 in San Francisco.
Primary endpoints included recurrence-free survival (RFS); distant metastasis-free survival (DMFS) as defined by time to any metastatic event beyond the primary tumor; and melanoma-specific survival (MSS). Survival rates by sentinel lymph node (SLN) status were also included for patients who underwent SLN biopsy.
The DecisionDx-Melanoma test identified 74 percent of patients who experienced disease recurrence and 74 percent of patients who had a distant metastasis. The test was comparable to SLN in predicting the five-year survival rates for high-risk patients, but superior to SLN in low-risk patients.
At the ACMS meeting, another report was presented titled, “Comparative Analysis of Outcomes Prediction Between a Prognostic 31-Gene Expression Profile and Sentinel Lymph Node Biopsy in a Cohort of 690 Cutaneous Melanoma Subjects.”
This time, the accuracy of the DecisionDx-Melanoma test used in combination with sentinel lymph node (SLN) status to predict outcomes of head and neck melanoma showed that combining the two tests was superior to testing with SLN alone in determining the risk of recurrence and of distant metastasis.
The two tests used in combination identified 87 percent of recurrences, 88 percent of distant metastases, and 95 percent of melanoma-specific deaths. This was compared to lymph node status alone, which identified 54 percent of recurrences, 57 percent of distant metastases, and 67 percent of melanoma-specific deaths.
“Melanoma incidence is on the rise and it is estimated that there will be over 87,000 new cases of the disease in 2017,” Federico A. Monzon, MD and chief medical officer of Castle Biosciences, said in a press release. “Approximately 20% of melanoma patients have disease in the head and neck region, and these patients exhibit higher rates of recurrence, compared to melanoma in other locations.”
“We believe that the DecisionDx-Melanoma test has the ability to address the growing challenge of providing accurate and reliable prognostic information that patients and physicians can use to make important management decisions — particularly in a disease setting such as head and neck melanoma, in which unique clinical challenges can hamper the prognostic value of traditional staging,” Monzon added.
