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TEST:
DecisionDx®-UM

Type:
Laboratory Developed Test
Related tests:
Evidence

News

12d
Largest Prospective Study to Date Further Supports Performance of DecisionDx-UM for Metastatic Risk Stratification in Uveal Melanoma and Utility of PRAME Biomarker for Refining Risk When Considered with DecisionDx-UM Class Result (Businesswire)
P=NA | N=1,586 | "Castle Biosciences...announced new data from a study further confirming the performance of its DecisionDx-UM test as a robust independent predictor of metastasis-free survival (MFS) in patients diagnosed with UM....The data was presented at the Association for Research in Vision and Ophthalmology (ARVO) 2024 Annual Meeting....In the study, a DecisionDx-UM Class 2 result was the most robust independent predictor of MFS (HR 6.03; 95% CI, 4.49-8.09); P<0.001), followed by PRAME status (HR 1.77; 95% CI, 1.39-2.27; P<0.001). Patients with Class 2 tumors had considerably worse outcomes than those with Class 1 tumors, regardless of PRAME status; however, PRAME+ tumors fared worse within each GEP class (versus PRAME-). When considered together, five-year MFS rates were 95.6% (95% CI, 93.9-97.4) for Class 1/PRAME-, 80.6% (73.9-87.9) for Class 1/PRAME+, 57.6% (50.6-65.7) for Class 2/PRAME- and 44.8% (38.0-52.8) for Class 2/PRAME+."
Clinical data
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DecisionDx®-PRAME • DecisionDx®-UM
25d
Clinical • Next-generation sequencing • Gene Expression Profile • Gene expression profiling
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PRAME (Preferentially Expressed Antigen In Melanoma)
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DecisionDx®-UM
1m
Impact of gene expression profiling on diagnosis and survival after metastasis in patients with uveal melanoma. (PubMed)
There were no significant differences in time to metastasis diagnosis and survival outcomes in patients with and without GEP. To realize the full benefit of GEP, more sensitive techniques for detection of metastasis and adjuvant therapies are required.
Journal
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DecisionDx®-UM
7ms
Castle announces early exploratory study data for potential development of a complementary test to accompany DecisionDx®-UM that could aid in the early detection of uveal melanomas (Castle Biosciences Press Release)
"Castle Biosciences, Inc...announced new discovery data from an ongoing study exploring the potential for developing a complementary, minimally invasive test to evaluate small, suspicious lesions of uncertain malignant potential in patients eyes."
Clinical data
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DecisionDx®-UM
9ms
Journal • Gene Expression Profile
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DecisionDx®-UM
12ms
Castle Biosciences to share new data on DecisionDx®-Melanoma and DecisionDx®-UM at the 2023 ASCO annual meeting (Castle Biosciences Press Release)
"Castle Biosciences, Inc...announced that new data on DecisionDx®-Melanoma and DecisionDx®-UM will be shared during the 2023 American Society of Clinical Oncology (ASCO) Annual Meeting, taking place June 2-6."
Clinical data
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DecisionDx®-Melanoma • DecisionDx®-UM
1year
Long-term outcomes in a population-based cohort of 2,967 uveal melanoma patients clinically tested with the 15-gene expression profile: A collaborative study with the National Cancer Institute (NCI) Surveillance, Epidemiology, and End Results (SEER) Program Registries. (ASCO 2023)
In this analysis, the 15-GEP accurately stratified risk of death from UM in a clinically tested, population-based cohort of patients, confirming previous studies. Socioeconomic status did not impact the likelihood of getting a high-risk result, suggesting equitable access to care for patients who receive 15-GEP testing. Ongoing analyses of SEER-linked UM data will include patients who received a PRAME test result, allowing for assessment of this adjunctive biomarker in combination with the 15-GEP result.
Clinical • Gene Expression Profile
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PRAME (Preferentially Expressed Antigen In Melanoma)
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DecisionDx®-UM
1year
Adjuvant polypeptide vaccines for high-risk uveal melanoma. (ASCO 2023)
Melanoma polypeptide vaccines are immunogenic and safe in patients with uveal melanoma. Our early data suggests the possibility of early benefit with direct antigen response, though longer follow up and further study will be needed to investigate these findings.
Clinical
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IFNG (Interferon, gamma) • PRAME (Preferentially Expressed Antigen In Melanoma)
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DecisionDx®-UM
over1year
Research Published in Melanoma Management Finds that 99% of Patients with Uveal Melanoma Tested with DecisionDx-UM Gain Value from the Results (Castle Biosciences Press Release)
"Castle Biosciences, Inc...announced the publication of a study completed in collaboration with the Melanoma Research Foundation (MRF) in which most patients diagnosed with uveal melanoma (UM) indicated their desire for prognostic testing at diagnosis, reported finding value in their test result and experienced lower decision regret, regardless of whether their test result indicated that their UM tumor was at a high or low risk of metastasis...Highlights from the study include the following...Patients who received a low-risk (Class 1A) DecisionDx-UM result were 10 times more likely than those who received a high-risk (Class 2) result to report gaining a 'sense of relief from uncertainty about the future.' (X2=11, df=1, p=0.0009). Conversely, a majority of patients who received a high-risk (Class 2) result reported that their test result provided them 'increased knowledge and understanding' about their disease (X2=17.48, df=3, p=0.0006)."
Clinical data
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DecisionDx®-UM
over1year
Castle Biosciences Presents New Data from Collaboration with the National Cancer Institute’s (NCI) Surveillance, Epidemiology and End Results (SEER) Program (Businesswire)
P=NA | N=4,687 | "In the study, DecisionDx-Melanoma was a statistically significant and independent predictor of melanoma-specific survival (MSS), consistent with previously published retrospective and prospective studies. Patients with stage IIB or IIC melanoma and a low-risk (Class 1A) DecisionDx-Melanoma test result had higher three-year MSS than patients with a high-risk (Class 2B) result (Class 1A: 100% vs. Class 2B: 88.3%, p=0.04); similar results were observed for patients with stage III CM (Class 1A: 96.1% vs. Class 2B; 79.6%, p=0.03). Additionally, DecisionDx-Melanoma was a statistically significant and independent predictor of MSS across all stages of disease, with a hazard ratio of 7.00 for the Class 2B result."
Clinical data
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DecisionDx®-Melanoma • DecisionDx®-UM
over1year
Characterizing metastatic uveal melanoma patients who develop symptomatic brain metastases. (PubMed, Front Oncol)
Since most patients in this cohort were symptomatic, the incidence of asymptomatic BM remains unknown. These data suggest the use of routine brain imaging in all mUM patients at risk for developing BM for early detection.
Journal
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DecisionDx®-UM
over1year
Uveal melanoma patient attitudes towards prognostic testing using gene expression profiling. (PubMed, Melanoma Manag)
Decision regret did not differ based on GEP class. Most uveal melanoma patients desire prognostic testing and gain value from the GEP, independent of a high- or low-risk result.
Journal • Prognostic test
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DecisionDx®-UM
almost2years
Patients with uveal melanoma tested with DecisionDx®-UM report gaining value from test results in study conducted in collaboration with the Melanoma Research Foundation’s CURE OM initiative (Castle Biosciences Press Release)
"Castle Biosciences, Inc...announced findings from a study that evaluated uveal melanoma (UM) patients’ attitudes toward prognostic testing and specifically with respect to DecisionDx-UM®. Highlights from the study were shared in a poster presentation at the 20th congress of the International Society of Ocular Oncology (ISOO), recently held in Leiden, The Netherlands."
Clinical data
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DecisionDx®-UM
2years
Enrollment change • Trial completion
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DecisionDx®-UM
2years
Randomized phase II study of adjuvant sunitinib or valproic acid in high-risk patients with uveal melanoma: The final analysis of cohort 1. (ASCO 2022)
Six months of adjuvant sunitinib or VPA resulted in 2-year OS of 95.6% and 90.7%, respectively, meeting the primary endpoint of the study. Sunitinib showed a tendency for a better outcome until 3 years after randomization, thus Cohort 2 was created to investigate the safety and prolonged improvement of RFS and OS with 12 months of sunitinib. Additionally, Cohort 3 with adjuvant sunitinib in combination with VPA for 12 months is currently ongoing.
P2 data • Clinical
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HLA-A (Major Histocompatibility Complex, Class I, A)
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HLA-A*02:01 • HLA-A*02
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DecisionDx®-UM
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sunitinib
over2years
Data published in Ocular Oncology and Pathology demonstrates highly accurate performance of DecisionDx®-UMSeq for patients with uveal melanoma (Castle Biosciences Press Release)
"Castle Biosciences...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)...The 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."
Clinical data
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DecisionDx®-UM
over2years
CLEAR: 5 Year Registry Study to Track Clinical Application of DecisionDx-UM Assay Results and Associated Patient Outcomes (clinicaltrials.gov)
P=N/A; Trial completion date: Oct 2020 --> Feb 2022 | Trial primary completion date: Oct 2020 --> Feb 2022
Trial completion date • Trial primary completion date • Clinical
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DecisionDx®-UM