NEW YORK (GenomeWeb) – Medicare contractor Palmetto GBA on Thursday issued a final local coverage determination for Castle Biosciences' DecisionDx-Melanoma assay, a prognostic test for cutaneous melanoma that helps guide use of sentinel lymph node biopsy (SLNB).
The LCD extends coverage of the assay for SLNB-eligible patients with T1 and T2 cutaneous melanoma tumors, as well as patients with clinically negative sentinel node basins who are being considered for SLNB to determine eligibility for adjuvant therapy.
The final LCD takes effect on Dec. 3, 2018, at which time Medicare beneficiaries will have improved access to the assay to help guide the use of SLNB within patient-specific management plans.
Castle's DecisionDx-Melanoma test is a 31-gene expression profile that determines a patient's risk for metastatic disease using tissue from the primary melanoma. The tool classifies patients as having a tumor with low or high risk for developing metastasis within five years of diagnosis.
According to Castle, about 12,000 patients have used the melanoma test in the last year to improve management decisions and guide melanoma care. The firm said that the tool is supported by more than 15 peer-reviewed publications including analytical and clinical validation, performance studies, and clinical utility in prospective and retrospective studies.
The company has also published two clinical studies that showed that a Class 1A test result can identify a population with greater than a 95 percent likelihood of a negative SLNB.
"Using the DecisionDx-Melanoma test to identify low-risk tumor biology and inform the discussion of SLNB options provides an important advance in the management of early-stage melanoma patients," Castle CEO and President Derek Maetzold said in a statement.