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Follow on Google News | Castle Biosciences licenses use of gene to detect metastasis in uveal and cutaneous melanomaFurther validation is needed, but studies indicate that the BAP1 gene predicts metastasis of ocular melanoma tumors
Researchers at Washington University School of Medicine discovered the link between the BAP1 gene and metastasis. This discovery was first reported by the laboratories of Drs. J. William Harbour and Anne Bowcock in 2010 in the journal Science. Castle Biosciences has initiated validation studies for the use of this technology in both uveal melanoma (commonly referred to as ocular melanoma) and cutaneous melanoma. The company has initiated plans to incorporate BAP1 as a target in its DecisionDx-UM assay. The company currently offers the proprietary DecisionDx-UM assay as a laboratory test service. The DecisionDx-UM assay is a gene expression assay that has been technically and clinically validated using independent retrospective and prospective study designs for classifying primary uveal melanoma tumors as Class 1 or Class 2 tumors. Patients with class 1 tumors have been shown to have a low likelihood of developing metastasis whereas those with a class 2 tumor have a high likelihood of metastasis. Peer-reviewed published studies have shown gene expression profile assays to be the most accurate predictor of metastatic risk in patients with uveal melanoma. The DecisionDx-UM assay has been incorporated into routine clinical care by the majority of ocular oncologists in North America. Background on uveal melanoma and the DecisionDx-UM assay: Although uveal melanoma is the most prevalent form of eye cancer and the second most common site of melanoma, it is a rare cancer with an annual estimated U.S. incidence of 2,000. Treatments for the primary tumor are highly effective with published local control rates greater than 90%. While less than 5% of patients present with clinically overt metastasis at the time of initial diagnosis, nearly half of all patients will develop metastatic disease, most of which occur within 5 years of diagnosis. The primary clinical issue, then, is accurately identifying which patients may have already developed micro-metastatic disease that is below the level of detection using today’s advanced imaging techniques (so called Class 2 tumors) from those patients who have a low likelihood that their tumor had micro-metastasized at the time of treating the eye tumor (Class 1 tumors). The DecisionDx-UM assay was discovered at Washington University for the purpose of developing a robust and accurate assay to enable prospective identification of patients with Class 1 or Class 2 tumors. Castle Biosciences entered into an exclusive worldwide license with Washington University for the technology underlying the DecisionDx-UM assay. The company completed development and validation studies and the assay is available for routine clinical use. The assay may only be ordered by a licensed physician. For more information on BAP1 or the DecisionDx-UM uveal melanoma assay, please visit us online or call Castle Biosciences. # # # Castle Biosciences is a molecular diagnostics company whose mission is to serve individuals afflicted with rare or orphan cancers and those who care for them. End
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