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Data Published in Ocular Oncology and Pathology Demonstrates Highly Accurate Performance of DecisionDx®-UMSeq for Patients with Uveal Melanoma
DecisionDx-UMSeq identified somatic mutations relevant to uveal melanoma and is indicated as a complement to DecisionDx®-UM and DecisionDx®-PRAME, using the
About this update from Castle Biosciences, Inc.
[{"type":"text","content":"\nDecisionDx-UMSeq identified somatic mutations relevant to uveal melanoma and is indicated as a complement to DecisionDx®-UM and DecisionDx®-PRAME, using the same biopsy tissue\n\n FRIENDSWOOD, Texas--(BUSINESS WIRE)--\nCastle Biosciences, Inc. (Nasdaq: CSTL), a leader in transforming disease management and improving patient outcomes through innovative diagnostics, today announced the publication of a study demonstrating that the combined application of DecisionDx®-UM, DecisionDx®-PRAME and DecisionDx®-UMSeq allows for highly accurate analysis of RNA and DNA from a single biopsy sample for patients with uveal melanoma (UM).\n\nDecisionDx-UMSeq is Castle’s 7-gene test that uses next-generation sequencing (NGS) to identify somatic mutations relevant to uveal melanoma. The sequencing panel identifies hotspot mutations in the genes GNAQ, GNA11, CYSLTR2, PLCB4 and SF3B1, mutations in exons 1-2 of EIF1AX and mutations across all coding exons of the BAP1 gene. This information, together with results from the DecisionDx-UM gene expression profile (GEP) test, is designed to help build a comprehensive genomic profile of an individual UM tumor from a single biopsy, which can then be used to inform patient care. DecisionDx-UM is Castle’s 15-GEP test that uses an individual patient’s tumor biology to predict individual risk of metastasis. DecisionDx-UM is the standard of care in the management of newly diagnosed UM in the majority of ocular oncology practices in the United States.\n\nThe study titled, “Analytical validation and performance of a 7-gene next-generation sequencing panel in uveal melanoma,” was recently published in the peer-reviewed journal Ocular Oncology and Pathology. The study, which can be viewed here, was designed to evaluate the analytical performance of the DecisionDx-UMSeq panel, which can be run from the same fine needle aspiration biopsy (FNAB) or formalin-fixed paraffin-embedded (FFPE) biopsy sample that is used to run the DecisionDx-UM test.\n\n“The study results demonstrated that running the DecisionDx-UMSeq panel in combination with DecisionDx-UM and DecisionDx-PRAME produced highly accurate results using only a single biopsy sample,” said J. William Harbour, M.D., Professor and Chair of the Department of Ophthalmology at UT Southwestern Medical Center. “Patients with the rare and deadly uveal melanoma have limi...