Clinical experience results demonstrate robust clinical reproducibility and reliability of DecisionDx-Melanoma and DecisionDx-UM prognostic tests
Friendswood, TX – November 14, 2016 – Castle Biosciences, Inc., a provider of molecular diagnostics to improve cancer treatment decisions, today announced results from studies evaluating clinical experience with gene expression profile (GEP) tests DecisionDx®-Melanoma and DecisionDx®-UM. In the studies, both GEP tests demonstrated a high technical success rate with robust, reproducible and reliable performance. The data were presented in poster sessions at the Association for Molecular Pathology (AMP) 2016 Annual Meeting, which was held in Charlotte, North Carolina from November 10-12.
“The high technical success rate of the DecisionDx-Melanoma and DecisionDx-UM prognostic tests make them integral to patient care, particularly when tumor tissue samples are limited,” commented Federico A. Monzon, M.D., FCAP, Chief Medical Officer of Castle Biosciences and President of AMP. “The studies show these GEP tests can be relied on to produce consistent and accurate results that can help guide important treatment and follow-up care decisions.”
DecisionDx-Melanoma: Study Details
In a study titled, “Clinical Reliability and Reproducibility of a Prognostic 31-Gene Expression Profile Test for Cutaneous Melanoma, and Association of the Test with Standard Clinicopathologic Features” (poster S117), the test was evaluated for analytical reliability and reproducibility of results. Investigators also evaluated the clinical experience with the test and the association of risk prediction with standard staging factors linked to cutaneous melanoma metastasis and death.
The test demonstrated robust, reproducible and reliable performance in primary tumor formalin-fixed paraffin-embedded (FFPE) specimens. Technical success for the most recent 6-month period examined (January 1, 2016-June 30, 2016) remained high at 99%. Educational efforts to improve biopsy tissue conservation practices were also effective with pre-analytic rejections for insufficient tumor cellularity falling to 4% during this time period.
DecisionDx-UM: Study Details
In a study titled, “Clinical Experience with the 15-Gene Expression Profile (GEP) test for Uveal Melanoma Prognostication and Association with Pathologic Features” (poster S92), DecisionDx-UM was evaluated for technical reliability and reproducibility, overall molecular classifications, and correlations with pathologic features. In the study, researchers found a technical success of 96% among 5516 samples collected between January 2010 and May 2016.
The DecisionDx-Melanoma test uses tumor biology to provide an individual risk of melanoma recurrence beyond traditional factors. Using tissue from the primary melanoma, the test measures the expression of 31 genes. The test has been validated in three multi-center studies demonstrating consistent results in over 800 patients. Performance has been confirmed in two independent, prospective studies of over 400 patients. The consistent, high rate of accuracy demonstrated in these studies provides confidence in disease management plans that incorporate DecisionDx-Melanoma test results. Clinical impact has been demonstrated in a multi-center study showing that test results add additional patient-specific prognostic information to complement traditional staging tools. More information about the test and disease can be found at www.SkinMelanoma.com.
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. It is the only test for uveal melanoma that has achieved National Cancer Institute/National Comprehensive Cancer Network Level of Evidence 1A, a critical factor in test adoption and clinical decision-making. Additionally, the American Joint Committee on Cancer recommends gene expression profile testing for use as the results are “clinically significant.” The American Joint Committee on Cancer (AJCC, version 7, 2010) 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. 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 decisions about their treatment and follow up care based on the individual molecular signature of their tumor. The Company currently offers tests for patients with uveal melanoma (DecisionDx®-UM; www.MyUvealMelanoma.com, and DecisionDx®-PRAME) and cutaneous melanoma (DecisionDx®-Melanoma; www.SkinMelanoma.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-UM, DecisionDx-Melanoma and DecisionDx-PRAME are the trademarks of Castle Biosciences, Inc. Any other trademarks are the property of their respective owners.
James L Dunn, Jr., CFO