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High technical success rate maintained with testing of more than 5500 patients
Castle Biosciences, Inc., a provider of molecular diagnostics to improve cancer treatment decisions, today announced the publication of a study confirming the robust, reproducible performance characteristics of the DecisionDx®-UM test, the standard of care prognostic tool for patients with uveal melanoma (UM), an aggressive form of eye cancer.
The paper, titled “Gene Expression Profiling in Uveal Melanoma: Technical Reliability and Correlation of Molecular Class with Pathologic Characteristics,” was published online this week in the journal Diagnostic Pathology. The study evaluated performance metrics of the 15-gene expression profile (GEP) test in Castle’s CLIA-certified laboratory setting, including concordance of test results from samples subjected to repeat testing, description of technical success, and correlation of results with pathologic variables. These metrics are especially important factors in validating the accuracy of UM molecular tests since most UM patients receive eye-sparing radiotherapy, thus limiting the amount of available tissue.
Key Study Findings
“Molecular testing in uveal melanoma is performed on limited and precious samples, so high technical success and reliability are critical,” said Federico Monzon, M.D., Chief Medical Officer of Castle Biosciences and study author. “The DecisionDx-UM test is currently used in approximately 80% of UM patients in the U.S. as part of their diagnostic workup. The consistent robust performance of the GEP test, as evidenced by this study, supports the continued use and adoption of the assay in clinical practice to better inform patient management decisions.”
The publication is open access and may be found at: http://rdcu.be/uLs4.
DecisionDx-UM is the only prognostic test for uveal melanoma that has been clinically validated for accuracy in multiple prospective and retrospective multicenter and single-center studies.1-6 According to a 446-patient study conducted by the Collaborative Ocular Oncology Group, the DecisionDx-UM test is clinically and statistically superior to all other prognostic factors in predicting metastatic risk, including clinical and pathologic factors, as well as chromosome 3 testing.1 These results are comparable to previous and subsequent single-center and multicenter prospective and retrospective studies.2-6 Two published clinical utility studies have shown clinically significant impact on patient management.7,8
The DecisionDx-UM test measures the gene expression profile (GEP), or molecular signature, of an individual’s tumor and identifies with high accuracy the likelihood of metastasis. The DecisionDx-UM test is standard of care in the management of uveal melanoma in the majority of ocular oncology practices (more than 130 specialists ordered the test in 2016). Since 2009, the American Joint Committee on Cancer (AJCC; v7 and v8) has included gene expression profiling for identification of Class 1 and 2 as a prognostic factor recommended for clinical care. The AJCC is the only national organization that reviews uveal melanoma and the DecisionDx-UM test is the only clinically available GEP test for use in the U.S. The test has been validated in multiple prospective and retrospective studies. It is estimated that nearly 8 in 10 diagnosed patients in the U.S. receive DecisionDx-UM as part of their diagnostic workup. More information about the test and disease can be found at www.MyUvealMelanoma.com.
About Castle Biosciences
Castle Biosciences is a molecular diagnostics company dedicated to helping patients and their physicians make the best possible treatment and follow-up care decisions based on the individual molecular signature of their tumor. The Company currently offers tests for patients with cutaneous melanoma (DecisionDx®-Melanoma; www.SkinMelanoma.com) and uveal melanoma (DecisionDx®-UM and DecisionDx®-PRAME; www.MyUvealMelanoma.com), with development programs in other underserved cancers. Castle Biosciences is based in Friendswood, TX (Houston), and has laboratory operations in Phoenix, AZ. More information can be found at www.CastleBiosciences.com.
DecisionDx-Melanoma, DecisionDx-UM and DecisionDx-PRAME are the trademarks of Castle Biosciences, Inc. Any other trademarks are the property of their respective owners.
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