On March 5, 2020 Castle Biosciences, Inc. (Nasdaq: CSTL), a skin cancer diagnostics company providing personalized genomic information to improve cancer treatment decisions, reported that the United States Patent and Trademark Office (USPTO) issued the Company its first U.S. patent related to the DecisionDx-Melanoma gene expression profile test for patients with cutaneous melanoma (Press release, Castle Biosciences, MAR 5, 2020, View Source [SID1234555235]).
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Patent No. 10,577,660, issued on March 3, 2020, covers methods of treating cutaneous melanoma in patients having high-risk cutaneous melanoma tumors. The inventors discovered that patients having high-risk cutaneous melanoma tumors can be identified by the gene-expression profile signature of their cutaneous melanoma tumors. The term of the patent extends until September 2034. This brings the total number of issued or allowed patents related to the Company’s DecisionDx-Melanoma test to 10.
"We are pleased to have been issued our first U.S. patent covering DecisionDx-Melanoma," said Derek Maetzold, Castle’s president and chief executive officer. "In the United States, we estimate approximately 130,000 patients are diagnosed with Stage I-III cutaneous melanoma each year. The clinical use of DecisionDx-Melanoma is designed to optimize post-diagnostic treatment decisions, including sentinel lymph node biopsy, frequency of follow-up and the need for imaging, which we believe will lead to improved health outcomes for patients with skin cancer."
Castle Biosciences’ DecisionDx-Melanoma test is a 31-gene expression profile prognostic test for cutaneous melanoma that predicts 5-year risk of metastasis as low risk (Class 1, 1A lowest risk) or high risk (Class 2, 2B highest risk), as well as metastasis to the sentinel lymph node, based on an individual patient’s tumor biology.
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 1600 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. Since its commercial launch through December 31, 2019, DecisionDx-Melanoma has been ordered 51,967 times for use in patients with cutaneous melanoma.
More information about the test and disease can be found at www.SkinMelanoma.com.