NEW YORK (GenomeWeb) – Medicare contractor Palmetto GBA has issued a final local coverage determination for Castle Biosciences’ DecisionDx-UM, a prognostic test for uveal melanoma.
The LCD extends coverage for the DecisionDx-UM test to assess metastatic risk for newly diagnosed uveal melanoma patients, as well as to guide surveillance and referral to medical oncology.
According to the company, national payor Aetna will now also cover the test, as well as 14 Blue Cross Blue Shield (BCBS) insurance plans in California, Florida, New Jersey, North Carolina, Michigan, Massachusetts, Washington, Oregon, Alabama, Arizona, Louisiana, Utah, Idaho, and Alaska. Castle CEO Derek Maetzold said in a statement that these recent coverage determinations will extend access to DecisionDx-UM to 57 million Medicare recipients and 58 million insurance beneficiaries under BCBS and Aetna commercial plans.
DecisionDx-UM has been validated in multiple studies, including an analysis involving more than 400 patients that showed DecisionDx-UM to be “clinically and statistically superior to all other prognostic factors in predicting metastatic risk, including clinical and pathologic factors, as well as chromosome 3 testing,” Castle highlighted in a statement. The company has also published two clinical utility studies that showed its test had a significant impact on patient management.