On October 8, 2020 Castle Biosciences, Inc. (Nasdaq: CSTL), a skin cancer diagnostics company providing personalized genomic information to improve cancer treatment decisions, reported that Medicare Administrative Contractor, Palmetto GBA MolDx, has issued a final expanded local coverage determination (LCD) for the company’s DecisionDx-Melanoma test. The LCD effective date is Nov. 22, 2020 (Press release, Castle Biosciences, OCT 8, 2020, View Source [SID1234568236]). Details on the LCD and the billing and coding article are posted to the Medicare Coverage Database on the Centers for Medicare and Medicaid Services (CMS) website.
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DecisionDx-Melanoma is a gene expression profile test that uses an individual patient’s tumor biology to predict individual risk of cutaneous melanoma metastasis or recurrence, as well as sentinel lymph node positivity, independent of traditional staging factors. The test has been studied in more than 5,700 patient samples.
"We are pleased to have received positive expanded coverage for our DecisionDx-Melanoma test for patients diagnosed with cutaneous melanoma," said Derek Maetzold, president and chief executive officer of Castle Biosciences. "We believe that adding the personalized genomic information provided by our DecisionDx-Melanoma test to traditional clinical and pathology factors can help clinicians and their patients make improved treatment decisions. This coverage decision provides greater access to our test for people with melanoma, as it allows additional Medicare beneficiaries to incorporate DecisionDx-Melanoma into their management plans."
Castle Biosciences plans to continue generating and publishing scientific data to demonstrate enhanced clinical utility of the DecisionDx-Melanoma test, which is currently supported by 26 peer-reviewed publications.
About DecisionDx-Melanoma
DecisionDx-Melanoma is a gene expression profile test that uses an individual patient’s tumor biology to predict individual risk of cutaneous melanoma metastasis or recurrence, as well as sentinel lymph node positivity, independent of traditional staging factors, and has been studied in more than 5,700 patient samples. Using tissue from the primary melanoma, the test measures the expression of 31 genes. The test has been validated in four archival risk of recurrence studies of 901 patients and six prospective risk of recurrence studies including more than 1,600 patients. Prediction of the likelihood of sentinel lymph node positivity has also been validated in two prospective multicenter studies that included more than 3,000 patients. Impact on patient management plans for one of every two patients tested has been demonstrated in four multicenter and single-center studies including more than 560 patients. The consistent performance and accuracy demonstrated in these studies provides confidence in disease management plans that incorporate DecisionDx-Melanoma test results. Through June 30, 2020, DecisionDx-Melanoma has been ordered more than 59,900 times for use in patients with cutaneous melanoma.