By Ron Shinkman, Editor, Laboratory Industry Report
A new clinical study conducted in conjunction with the Texas-based Castle Biosciences, Inc. suggests that its molecular assay for melanoma patients can assist in determining whether their particular cancer will spread.
The test focuses on the gene expression profile of each patient’s melanoma. The clinical study focused on the efficacy of Castle’s test, known as DecisionDx-Melanoma, in comparison with the biopsy of lymph nodes, which is the accepted method for predicting whether the melanoma will spread to other parts of the body. A total of 217 patients were included in the study.
The assay was able to predict 80 percent of the time whether the melanoma would metastasize. That’s compared to about a 30 percent success rate in correctly predicting the disease’s course through biopsy.
Melanoma is the only form of skin cancer that has the potential to be deadly. About 76,000 Americans are diagnosed with melanoma every year, and about 10,000 die from the disease. The number of cases in the United States has been rising every year for the past two decades, according to the American Cancer Society. The five-year survival rates for melanoma are high in the earliest stages, but they drop quickly in the intermediate stages of the disease.
“We know that a positive sentinel lymph node biopsy result identifies 25 to 35 percent of patients who will die from melanoma. The study data show that combined use of SLNB and the gene expression profile test could identify greater than 80 percent of patients with a specificity similar to SLNB alone, giving physicians and patients actionable information for the management of melanoma,” said Pedram Gerami, M.D., one of the study’s authors. He is an associate professor of dermatology and director of melanoma research at the Northwestern Skin Cancer Institute.