FRIENDSWOOD, Texas--(BUSINESS WIRE)--Castle Biosciences, Inc., a provider of molecular diagnostics to improve cancer treatment decisions, today announced new study results of the Company’s DecisionDx-UM gene expression profile test, verifying that the assay is highly effective at identifying uveal melanoma tumors at high risk of metastasis. The results also confirmed the technical reliability of the test, which successfully classified 97% of uveal melanomas submitted for testing in this case series.
The study titled, “Gene expression profiling test of uveal melanoma: Prognostic validation,” was presented on November 13, 2015 at the American Society of Ophthalmic Plastic and Reconstructive Surgery (ASOPRS) 46th Annual Fall Scientific Symposium by Hakan Demirci, M.D., Director of Ocular Oncology and Associate Professor of Ophthalmology and Visual Sciences at the University of Michigan Kellogg Eye Center. Clinical data were collected from 210 consecutively diagnosed uveal melanoma patients who received the DecisionDx-UM test and were managed at this center.
Study Results
All uveal melanoma tumor tissue was submitted to Castle Biosciences for analysis using the Company’s DecisionDx-UM assay to classify as either low or high risk for metastasis. Study results showed 203 of the 210 tumors (97%) were successfully identified as either Class 1A (low risk), Class 1B (intermediate risk), or Class 2 (high risk). According to the Kaplan-Meier survival analysis, the metastatic-free survival rates were 95% for Class 1A patients, 90% for Class 1B patients, and 27% for Class 2 patients at 5 years.
“In our study, the uveal melanoma gene expression profile test showed a high rate of technical success,” said Dr. Demirci, lead study investigator. “The validity and accuracy of the test provides clinicians with the opportunity to implement risk-appropriate management strategies for patients with uveal melanoma.”
These data parallel the results of the previously reported prospective, multicenter Cooperative Ocular Oncology Group study1 as well as other archival tissue studies that showed a significantly higher risk associated with a Class 2 prediction, supporting the National Cancer Institute/National Comprehensive Cancer Network Level of Evidence 1A that has been achieved with the DecisionDx-UM test.
AAO 2015 Annual Meeting
In a separate study, data were presented on November 15th at the American Academy of Ophthalmology (AAO) 2015 Annual Meeting highlighting a new technique for choroidal melanoma biopsy designed to decrease the rate of biopsy-related vitreous hemorrhage and extraocular tumor extension. The study titled, “25-gauge vitrectomy with needle biopsy of choroidal melanoma for gene expression profiling (GEP) during brachytherapy,” was presented by Deepthi Reddy, M.D., of the Department of Ophthalmology at the University of Alabama-Birmingham.
Using the DecisionDx-UM test, which has been shown to be more accurate and require a significantly smaller sample size compared to other prognostic tests2, the study reported only 1 in 57 patients (1.8%) experienced post-operative vitreous hemorrhage and no patients reported extraocular tumor extension or local recurrence as a result of the biopsies performed.
“The strong predictive capabilities and high technical success of the DecisionDx-UM GEP test continue to be impressive. Multiple prospective validation studies have shown a high correlation between Class 1 and 2 risk prediction and outcomes for patients,” said Derek Maetzold, President and CEO of Castle Biosciences. “Our test provides clear and actionable information for physicians as they put in place the most appropriate follow-up care plans for their patients based on actual risk of their disease spreading.”
About Uveal Melanoma
Uveal melanoma is a rare malignancy, but is the most common form of eye cancer in the United States, with about 2,000 diagnoses per year. This form of eye cancer, sometimes referred to as ocular melanoma, may occur in any of the three parts of the uvea. Similar to other melanomas, uveal melanoma begins in cells called melanocytes that help produce the pigments of the skin, hair, and eyes. While most patients are middle-aged with fair skin, uveal melanoma can affect people of all complexions and ages.
Although a small percentage (3%) of patients with uveal melanoma have detectable metastatic lesions at the time of diagnosis or treatment of the primary tumor, up to 50% of patients will subsequently develop metastatic disease. That high rate of metastasis necessitates a rigorously validated, accurate, and reliable tool to identify patients likely to develop distant metastasis.
About DecisionDx-UM
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 (125 of the estimated 130 practices as of August, 2014) and 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 gene expression profile 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), cutaneous melanoma (DecisionDx-Melanoma), esophageal cancer (DecisionDx-EC), and mesothelioma (DecisionDx-Mesothelioma) among others. 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 is the trademark of Castle Biosciences, Inc.
1 Onken MD, et al. Collaborative Ocular Oncology Group report number 1: prospective validation of a multi-gene prognostic assay in uveal melanoma. Ophthalmology 2012;119(8):1596-603.
2 Onken MD, et al. An accurate, clinically feasible multi-gene expression assay for predicting metastasis in uveal melanoma. J Mol Diagn 2010;12:461-68.