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TEST:
DecisionDx®-Melanoma

Type:
Laboratory Developed Test
Related tests:
Evidence

News

5d
Patients who forego sentinel lymph node biopsy after 31-GEP testing are not harmed: A prospective, multicenter analysis (EADO 2024)
The 31-GEP identified patients at low risk of SLN positivity who may safely forego SLNB, reducing healthcare costs and procedure complications. Longer follow-up may be needed to further validate this conclusion
Clinical • Biopsy
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DecisionDx®-Melanoma
5d
The health economic impact of the 31-gene expression profile test for treatment and surveillance management plans in patients with cutaneous melanoma (EADO 2024)
Importantly, >90% of savings occurred during the first year post-diagnosis. Conclusions For patients with stage I-IIIA CM, 31-GEP-guided clinical management decisions result in substantial cost savings, especially in the first year, for commercial payors compared to AJCC-guided care.
Clinical • HEOR • Gene Expression Profile • Gene expression profiling
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DecisionDx®-Melanoma
7d
Long-term outcomes data shared at SSO 2024 show that patients with a low-risk DecisionDx®-Melanoma test result were recurrence free at three years, including those who utilized the test to help guide the decision to avoid an SLNB (Castle Biosciences Press Release)
"Castle Biosciences...announced that new data highlighting the performance of its DecisionDx-Melanoma test in predicting risk of sentinel lymph node (SLN) positivity in patients with CM is being presented at the Society of Surgical Oncology 2024 (SSO 2024) Annual Meeting, being held March 20-23 in Atlanta."
Clinical data
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DecisionDx®-Melanoma
21d
Castle Biosciences to present new data highlighting the clinical value of its dermatologic tests for patients with skin cancer at the 2024 American Academy of Dermatology (AAD) annual meeting (Castle Biosciences Press Release)
"Castle Biosciences...announced that it will share data across its dermatologic portfolio of gene expression profile (GEP) tests via oral and electronic poster presentations at the 2024 AAD Annual Meeting, taking place March 8-12 in San Diego."
Clinical data
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DecisionDx®-Melanoma • DecisionDx®-SCC • myPath Melanoma
1m
Study Finds DecisionDx-Melanoma Significantly Improves the Risk Stratification of Patients with Stage I Melanoma Compared to American Joint Committee on Cancer 8th Edition Staging (Businesswire)
P=NA | N=7,000 | "Castle Biosciences, Inc...announced the publication of a study in Cancers1 demonstrating that DecisionDx-Melanoma provided significantly better risk stratification than American Joint Committee on Cancer 8th Edition (AJCC8) staging in patients with stage I cutaneous melanoma (CM)....In both cohorts, DecisionDx-Melanoma provided greater separation between patients with high- and low-risk test results than seen between AJCC8 stage IA and IB, demonstrating the ability of the test to provide improved risk stratification over staging. In the combined cohort, multivariable analysis showed that a DecisionDx-Melanoma Class 2B test result was the strongest predictor of recurrence in stage I CM (HR = 5.16, p < 0.001); similarly, in the SEER cohort, multivariable analysis indicated that a high-risk test result was the only significant predictor of melanoma-specific mortality in stage I patients (HR = 9.23, p < 0.001)."
Clinical data
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DecisionDx®-Melanoma
1m
31-GEP testing is associated with improved melanoma-specific survival relative to untested patients: an analysis of patients <65 years old (AAD 2024)
In this unselected, clinically tested cohort of CM patients <65 years old, the 31-GEP stratified risk of dying from melanoma and was associated with improved survival relative to untested patients.
Clinical
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DecisionDx®-Melanoma
2ms
The 31-Gene Expression Profile Test Outperforms AJCC in Stratifying Risk of Recurrence in Patients with Stage I Cutaneous Melanoma. (PubMed, Cancers (Basel))
The 31-GEP test significantly improved patient risk stratification, independent of AJCC8 staging in patients with stage I CM. The 31-GEP provided greater separation between high- (Class 2B) and low-risk (Class 1A) groups than seen between AJCC stage IA and IB. These data support integrating the 31-GEP into clinical decision making for more risk-aligned management plans.
Journal • Gene Expression Profile
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DecisionDx®-Melanoma
2ms
Castle Biosciences Presents Data Supporting the Utility of Its Tests in the Clinical Care of Patients with Skin Cancers at the 2024 Winter Clinical Dermatology Conference - Hawaii (Businesswire)
P=NA | N=NA | "The study confirmed the independent and significant risk-stratification provided by DecisionDx-Melanoma and its integrated i31-GEP ROR algorithm, identifying patients at high risk of melanoma recurrence to guide important, risk-appropriate interventions, such as imaging surveillance and immunotherapy, that can potentially improve patient outcomes....Within a cohort of SCC patients considered lower risk by current staging alone, DecisionDx-SCC identified those at a substantially higher risk of metastasis. These results represent a clinically significant improvement in risk assessment for SCC patients with observed rates of metastasis over 10% and 20%, respectively, which are clinically actionable for nodal staging or post-operative adjuvant radiation."
Clinical data
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DecisionDx®-Melanoma • DecisionDx®-SCC • myPath Melanoma
3ms
Clinical Utility of the 31-Gene Expression Profile Test on the Management of Cutaneous Melanoma by Nurse Practitioners and Physician Assistants. (PubMed, J Adv Pract Oncol)
The 31-GEP test significantly impacts treatment plans in CM, particularly for thin and stage I melanomas. Importantly, even nonusers stated that 31-GEP test results would impact treatment plans as well as recommendations to a friend or family member.
Journal • Gene Expression Profile
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DecisionDx®-Melanoma
3ms
Prospective validation of the integrated 31-gene expression profile test for cutaneous melanoma to select patients who may consider foregoing sentinel lymph node biopsy (SSO 2024)
In this prospective study, no patient with an i31-GEP for SLNB and predicted risk of < 5% had a positive SLN. The i31-GEP for SLNB identified a group of patients with T1-T2 cutaneous melanoma with < 5% risk of SLNB who should consider foregoing the procedure.Learning Objectives: Upon completion, participant will be able to understand how the integrated-31-gene expression profile test can identify patients with low risk of sentinel lymph node positivity. Upon completion, participant will be able to describe the results of DECIDE, a prospective multicenter study to assess the effect of 31-GEP results on sentinel lymph node biopsy decisions.
Clinical • Gene expression profiling • Gene Expression Profile • Biopsy
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DecisionDx®-Melanoma
4ms
Study Finds Nurse Practitioners and Physician Assistants Would Alter Patient Care Decisions Based on DecisionDx-Melanoma Test Results (Businesswire)
P=NA | N=NA | "Castle Biosciences, Inc...announced the publication of a study in the Journal of the Advanced Practitioner in Oncology (JADPRO) that assessed the viewpoints of NPs/PAs toward the clinical use of DecisionDx®-Melanoma in patients diagnosed with cutaneous melanoma.... NPs and PAs who attended one of three selected conferences in 2020 and 2021 were asked to complete an 18-question online survey about their viewpoints and clinical use of DecisionDx-Melanoma. Of the 369 NPs/PAs who completed the survey, 176 (47.7%) reported using the DecisionDx-Melanoma test in the prior 12 months."
Clinical data
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DecisionDx®-Melanoma
4ms
Castle Biosciences announces multiple data presentations at the 2023 American Society for Dermatologic Surgery annual meeting (Castle Biosciences Press Release)
"Castle Biosciences, Inc...announced that data spanning its dermatologic portfolio of gene expression profile (GEP) tests was recently presented at the 2023 American Society for Dermatologic Surgery (ASDS) Annual Meeting in Chicago."
Clinical data
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DecisionDx®-Melanoma • DecisionDx®-SCC • myPath Melanoma
5ms
New data highlights clinical utility and performance of Castle Biosciences’ dermatologic test portfolio at the 2023 fall clinical dermatology conference (Castle Biosciences Press Release)
"Castle Biosciences, Inc...announced that it will share new data across its dermatologic portfolio of gene expression profile (GEP) tests at the 2023 Fall Clinical Dermatology Conference® (FC23), taking place Oct. 19-22, 2023, in Las Vegas."
Clinical data
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DecisionDx®-Melanoma • DecisionDx®-SCC • myPath Melanoma
6ms
DecisionDx®-Melanoma outperforms memorial sloan kettering cancer center (MSKCC) nomogram in predicting sentinel lymph node positivity in patients with cutaneous melanoma (Castle Biosciences Press Release)
"Castle Biosciences, Inc...announced a new study demonstrating DecisionDx®-Melanoma outperforms a nomogram developed at the Memorial Sloan Kettering Cancer Center (MSKCC) in predicting the risk of sentinel lymph node (SLN) positivity in patients with cutaneous melanoma (CM)."
Clinical data
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DecisionDx®-Melanoma
6ms
The Integrated i31-GEP Test Outperforms the MSKCC Nomogram at Predicting SLN Status in Melanoma Patients. (PubMed, Anticancer Res)
Integrating the 31-GEP with traditional factors outperformed a nomogram that uses clinicopathologic factors alone to predict SLN status. Incorporating the i31-GEP into clinical practice could improve identification of patients for SLNB, resulting in better risk-aligned management.
Journal
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DecisionDx®-Melanoma
6ms
The 31-gene expression profile test stratifies recurrence-free and melanoma-specific survival in patients with stage IB-IIA and stage IIB cutaneous melanoma (SITC 2023)
The 31-GEP provided significant risk stratification for both recurrence and melanoma-specific mortality in patients with stage IB-IIA CM, a group that can have a nearly 40% recurrence rate but is not currently eligible for adjuvant immunotherapies. The 31-GEP provides personalized, independent risk stratification, which enhances adjuvant therapy selection in future clinical trials in this population.
Clinical • Gene expression profiling • Gene Expression Profile • IO biomarker
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DecisionDx®-Melanoma
6ms
The 31-gene expression profile test (31-GEP) predicts risk of death in a large, unselected population of Medicare-eligible patients: a Surveillance, Epidemiology and End Results (SEER) collaboration (ASDP 2023)
Conclusions : The 31-GEP stratified OS/MSS in patients 65 years. The 31-GEP provides valuable information about patient prognosis, independent of risk factors used in staging, that can help guide personalized, risk-aligned clinical management decisions for older patients with CM. Poster type: Poster Defense
Medicare • US reimbursement • Reimbursement • Clinical • Gene expression profiling • Gene Expression Profile
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DecisionDx®-Melanoma
6ms
Performance of the 23-gene expression profile (23-GEP) test by histopathological evaluation in an independent, multi-center performance cohort of cutaneous melanocytic neoplasms (ASDP 2023)
These data demonstrate that the 23-GEP has an overall accuracy of 91.2% (89.0–93.1%), further supporting its use as an ancillary test that can be integrated with clinical and histopathologic information to guide final diagnosis. Poster type: Poster Defense
Clinical • Gene expression profiling • Gene Expression Profile
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DecisionDx®-Melanoma
9ms
31-Gene Expression Profile Testing in Cutaneous Melanoma and Survival Outcomes in a Population-Based Analysis: A SEER Collaboration. (PubMed, JCO Precis Oncol)
In a population-based, clinically tested melanoma cohort, the 31-GEP stratified patients by their risk of dying from melanoma.
Journal • Gene Expression Profile
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DecisionDx®-Melanoma
9ms
Study Data from Castle Biosciences’ Collaboration with the National Cancer Institute’s SEER Program Registries Published in JCO Precision Oncology (Businesswire)
P=NA | N=3,258 | "Castle Biosciences, Inc...announced the publication of a study in JCO Precision Oncology1 in which DecisionDx®-Melanoma provided significant, independent risk stratification of patients with cutaneous melanoma (CM), beyond American Joint Committee on Cancer Eighth Edition (AJCC8) stage, which may help inform more personalized patient management decisions....DecisionDx-Melanoma was an independent predictor of patient outcomes; a Class 2B (high risk) DecisionDx-Melanoma test result was an independent predictor of melanoma-specific survival (HR= 7.00, 95% CI 2.70-18.00) and overall survival (HR= 2.39, 95% CI 1.54-3.70)....DecisionDx-Melanoma testing was associated with 29% lower melanoma-specific mortality (HR=0.71, 95% CI 0.53-0.94) and 17% lower overall mortality (HR=0.83, 95% CI 0.70-0.99) relative to patients who did not receive DecisionDx-Melanoma testing."
Clinical data
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DecisionDx®-Melanoma
10ms
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
11ms
Study Demonstrates Use of DecisionDx-Melanoma to Guide Treatment Decisions Resulted in Earlier Detection of Melanoma with Decreased Metastatic Tumor Burden Compared to Patients Without Surveillance Imaging Studies (Businesswire)
P=NA | N=NA | "Castle Biosciences, Inc...announced the publication of an independent, multi-center study in the Archives of Dermatological Research providing a direct chain of evidence that use of DecisionDx®-Melanoma test results to guide radiological surveillance could lead to improved patient outcomes....Patients in the experimental group who received DecisionDx-Melanoma testing and surveillance imaging had melanoma recurrences detected approximately ten months earlier than patients in the control group (p=0.049). The average tumor burden detected at patients’ melanoma recurrence was significantly lower in the experimental group compared to the control group (27.6 mm vs. 73.1 mm; p=0.027)....Of the patients with a recurrence, 82% in the experimental group and 71% in the control group started immunotherapy."
Clinical data
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DecisionDx®-Melanoma
11ms
Integrating the 31-gene expression profile test into clinical decision-making to guide risk-aligned care decisions for patients with stage I-III cutaneous melanoma: NCI-SEER Analysis. (ASCO 2023)
Because of recognized disease risk and drug efficacy, pembrolizumab immunotherapy has been approved for stage IIB-C patients... The SEER database allowed a non-biased analysis of a large cohort of patients with stage I-III CM who were tested with the 31-GEP. The 31-GEP identifies patients, including those with stage IIB-C disease, with favorable outcomes and could help physicians and patients decide whether to pursue adjuvant therapy. Moreover, the 31-GEP identities high-risk patients, including those with stage I disease, for whom more aggressive follow-up and early intervention should be considered.
Clinical • PD(L)-1 Biomarker • Gene Expression Profile • IO biomarker
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DecisionDx®-Melanoma
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Keytruda (pembrolizumab)
11ms
DecisionDx-Melanoma Provides Improved Risk Stratification Over American Joint Committee on Cancer (AJCC) Staging Alone in Stage I Melanoma Patients (Businesswire)
P=NA | N=NA | "Castle Biosciences, Inc...announced new data showing DecisionDx®-Melanoma can improve risk stratification over American Joint Committee on Cancer (AJCC) staging alone in patients with stage I cutaneous melanoma (CM)....In the study, DecisionDx-Melanoma provided significant and independent risk stratification of patients with stage I CM. Additionally, as reported in the study, the test added valuable prognostic information to AJCC staging to better stratify recurrence-free survival (RFS) and melanoma-specific survival (MSS) among patients with stage I CM....Importantly, the data demonstrate that patients with AJCC stage I CM who had a high-risk (Class 2B) DecisionDx-Melanoma test result were 5.4 times more likely to die from melanoma compared to patients staged as IB according to AJCC staging."
Clinical data
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DecisionDx®-Melanoma
11ms
The 31-gene expression profile outperforms AJCC and CP-GEP in stratifying risk of recurrence in patients with stage I cutaneous melanoma (EADO 2023)
In stage I CM patients, the 31-GEP provided more prognostic stratification of 5-year RFS and MSS than AJCC staging alone, while the CP-GEP test did not provide more stratification. Incorporating the 31-GEP into clinical practice can help guide risk-aligned care in a low-risk population by identifying high-risk patients who may be missed using AJCC staging alone.
Clinical • Gene Expression Profile
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DecisionDx®-Melanoma
1year
Routine imaging guided by a 31-gene expression profile assay results in earlier detection of melanoma with decreased metastatic tumor burden compared to patients without surveillance imaging studies. (PubMed, Arch Dermatol Res)
A higher percentage of experimental patients started immunotherapy when offered (76.3% and 67.9%). Patients who received routine imaging after high-risk GEP test scores had an earlier recurrence diagnosis with lower tumor burden, leading to better clinical outcomes.
Journal • Gene Expression Profile • IO biomarker • Metastases
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DecisionDx®-Melanoma
1year
Castle Biosciences to Highlight Clinical Value of Its Skin Cancer Tests at the 2023 American Academy of Dermatology (AAD) Annual Meeting (Businesswire)
"Castle Biosciences, Inc...announced that new data supporting its portfolio of skin cancer gene expression profile (GEP) tests will be showcased in one late-breaking oral presentation and three ePosters at the 2023 American Academy of Dermatology (AAD) Annual Meeting, being held March 17-21 in New Orleans."
Clinical data
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DecisionDx®-Melanoma • DecisionDx®-SCC • myPath Melanoma
1year
Recommendations by Expert Consensus Panel Relating to Risk-Stratification Tests and Tools for Use in Cutaneous Melanoma Have Been Adopted as an Official Policy Recommendation of the National Society for Cutaneous Medicine (Businesswire)
"Castle Biosciences, Inc...announced the publication of a consensus panel report from the National Society for Cutaneous Medicine recommending use of gene expression profile (GEP) testing in the clinical assessment and management of cutaneous melanoma (CM). The report provides usage guidelines and a framework for clinicians to integrate GEP testing into their CM patient management. Additionally, the consensus report endorses Castle’s DecisionDx®-Melanoma GEP risk stratification test as offering more utility than other existing CM GEP assays or nomograms, supported by extensive, evidence-driven data in current literature."
Clinical guideline
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DecisionDx®-Melanoma
1year
The 31-gene expression profile test for cutaneous melanoma identifies patients with stage IB-IIA disease who have recurrence risk similar to that of stage IIB-IIC disease (AAD 2023)
In patients with stage IB–IIA CM, i31-GEP identified those with high risk of recurrent disease, similar to that of stage IIB–IIC CM, for whom adjuvant therapy is approved. The i31-GEP can provide independent risk stratification to guide adjuvant therapy selection in future clinical trials in this population.
Clinical • Gene Expression Profile • IO biomarker
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DecisionDx®-Melanoma
1year
Real-world evidence • Clinical • Gene Expression Profile • Real-world • Biopsy
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DecisionDx®-Melanoma
1year
Data presentation at 2023 winter clinical - Miami highlights use of DecisionDx-Melanoma to guide SLNB surgery decisions in head and neck tumors (Castle Biosciences Press Release)
"Castle Biosciences, Inc...announced that new data on DecisionDx-Melanoma and the Company’s pipeline test for inflammatory skin diseases was presented at the recent 2023 Winter Clinical - Miami conference...The poster presentation for DecisionDx-Melanoma strengthens the evidence supporting use of the test to provide risk stratification for patients in order to guide risk-appropriate sentinel lymph node biopsy (SLNB) surgery decisions."
Clinical data
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DecisionDx®-Melanoma
1year
Prospective, multicenter study demonstrates that DecisionDx®-Melanoma test results can significantly reduce the number of Sentinel Lymph Node Biopsy (SLNB) procedures performed when used within the context of current guidelines (Castle Biosciences Press Release)
"Castle Biosciences announced the publication of data from a prospective, multicenter study, called DECIDE. In the study, DecisionDx®-Melanoma test results influenced 85% of clinicians’ decisions regarding the sentinel lymph node biopsy (SLNB) surgical procedure. Additionally, use of the tests’ results within current guideline recommendations led to a significant reduction in SLNB procedures performed, demonstrating the potential clinical value of the test to guide risk-aligned patient care."
Clinical data
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DecisionDx®-Melanoma
1year
Real-world evidence • Clinical • Gene Expression Profile • Real-world • Biopsy
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DecisionDx®-Melanoma
1year
Castle Biosciences’ Medical Director to Present at the Precision Medicine World Conference 2023 (Castle Biosciences Press Release)
"Castle Biosciences, Inc...announced that the Company’s medical director, Matthew Goldberg, M.D., F.A.A.D., board-certified dermatologist and dermatopathologist, will present at the Precision Medicine World Conference (PMWC®) 2023, being held Jan. 25-27 in Santa Clara, California....Dr. Goldberg will highlight several tests within Castle’s skin cancer and gastroenterology portfolios, including DecisionDx®-Melanoma, DecisionDx®-SCC and the TissueCypher® Barrett’s Esophagus test, and demonstrate how the personalized information the tests provide can help clinicians make more informed treatment decisions in the care of their patients to potentially improve patient outcomes."
Clinical data
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DecisionDx®-Melanoma • DecisionDx®-SCC
1year
Data presentations at 2023 winter clinical dermatology conference - Hawaii® support clinical value of castle biosciences’ skin cancer test portfolio (Castle Biosciences Press Release)
"Castle Biosciences, Inc...announced that new data supporting the clinical value of the Company’s skin cancer test portfolio is being shared in poster presentations at the 2023 Winter Clinical Dermatology Conference - Hawaii®, being held Jan. 13-18 in Kohala Coast, Hawaii."
Clinical data
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DecisionDx® DiffDx-Melanoma • DecisionDx®-Melanoma • DecisionDx®-SCC • myPath Melanoma
1year
The 31-gene expression profile test informs sentinel lymph node biopsy decisions in patients with cutaneous melanoma: results of a prospective, multicenter study. (PubMed, Curr Med Res Opin)
Overall, 85.3% of decisions relating to SLNB were influenced by 31-GEP results. In this prospective, multicenter study, clinicians demonstrated clinically meaningful use of the 31-GEP test to forego or pursue SLNB in patients with T1-T2 tumors resulting in a significant, risk appropriate decrease in SLNBs.
Journal • Clinical • Gene Expression Profile • Biopsy
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DecisionDx®-Melanoma
over1year
Clinical Utility of Dermoscopy and 31-Gene Expression Profiling by Dermatology Providers in Melanoma Management Care. (PubMed, J Drugs Dermatol)
This study represents our experience and understanding of the dermatologist’s role ordering 31-GEP in the care pathway of melanoma patients and we recommend that dermatology providers consider ordering the test for newly diagnosed CMM patients. J Drugs Dermatol. 2022;21(12): doi:10.36849/JDD.6889.
Journal
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DecisionDx®-Melanoma
over1year
Using Gene Expression Profiling to Personalize Skin Cancer Management. (PubMed, J Clin Aesthet Dermatol)
For patients with cutaneous squamous cell carcinoma who have at least one risk factor, the 40-GEP test allows for better risk stratification by identifying the high-risk patients who are most likely to develop metastasis. These tests can be easily integrated into clinical practice to help guide treatment choices.
Review • Journal
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DecisionDx®-Melanoma • DecisionDx®-SCC
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
New data from DECIDE study show the significant role of DecisionDx®-Melanoma test results and patient preference in decisions to perform the Sentinel Lymph Node Biopsy (SLNB) surgical procedure (Castle Biosciences Press Release)
"Castle Biosciences, Inc...announced new data from its prospective, multicenter DECIDE1 study in which DecisionDx®-Melanoma test results influenced 85% of clinicians’ decisions regarding the sentinel lymph node biopsy (SLNB) surgical procedure, demonstrating the role of the test’s results in guiding risk-aligned patient management decisions."
Clinical data
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DecisionDx®-Melanoma