TEST:

DecisionDx®-Melanoma

"The authors evaluated peer-reviewed articles that analyzed DecisionDx-Melanoma risk class data alongside at least one survival-based metric with a minimum of three years of follow-up...Across all studies, the DecisionDx-Melanoma test consistently stratified patients into risk groups with significantly different outcomes. The five-year melanoma-specific survival rates were: 99.8% (95% CI: 98–100%) for patients with a Class 1A/lowest risk test result, 97.6% (95% CI: 92.4–99.3%) for patients with a Class 1B/2A/increased risk test result and 83.4% (95% CI: 66.5–92.7%) for patients with a Class 2B/highest risk test result. Similar trends were observed for recurrence-free and distant metastasis-free survival, showing a significant separation of risk between patients with Class 1A and Class 2B test results."

This meta-analysis supports the prognostic utility of the 31-GEP test in cutaneous melanoma prognostication. The test consistently stratified patients into clinically meaningful risk groups across multiple survival metrics. These findings support the potential clinical utility of the 31-GEP test in enhancing current staging systems and informing personalized management strategies for melanoma patients.

P=NA | N=NA | "The study showed that integrating DecisionDx-Melanoma test results into SLNB decisions resulted in 25% fewer SLNBs performed compared to a matched patient cohort (p<0.001). Further, no patients with a DecisionDx-Melanoma-predicted risk of SLN positivity of less than 5% who decided to have an SLNB had a positive SLN (0/58 patients). Further, 9.8% of patients with a DecisionDx-Melanoma-predicted risk of SLN positivity of 5% or more who had the procedure did have a positive SLN."

P=NA | N=876 | "The data show DecisionDx-Melanoma stratified patients by their risk of recurrence and was a significant predictor of recurrence; patients with Class 1A (lowest risk) test results had significantly higher three-year recurrence-free survival than those with a Class 1B/2A (increased risk) or Class 2B (highest risk) test result (p<0.001). Importantly, the test added significant predictive value to American Joint Committee on Cancer (AJCC) staging, considered the standard of care in melanoma management. These findings provide evidence that use of the test with melanoma patients enables better risk-aligned care decisions, which have been shown to lead to improved patient outcomes."

In assessing if a CM gene expression panel could aid in the risk stratification of patients with CJM, we found that the uveal melanoma-relevant gene, BAP1, may be important. Additional studies with larger sample sizes are needed to determine the relevance of this and other differentially expressed genes in CJM prognostication.

Ethics Approval The study was IRB approved by WCG-IRB. All participating sites obtained institutional review board approval for this study, and patients provided written informed consent.

Due to the high-risk 31-GEP result, the patient was treated off-label with nivolumab for 1 year and received follow-up surveillance scans every 3 months for 3 years...The patient continues dermatologic screening every 6 months. The 31-GEP test provides valuable additional information to help clinicians make personalized, risk-based treatment and surveillance plans for patients with CM.

"Castle Biosciences, Inc...announced the publication of a new study further demonstrating that DecisionDx-Melanoma can precisely predict sentinel lymph node (SLN) positivity risk to help guide risk-aligned SLNB decisions, potentially reducing the number of unnecessary procedures and increasing the SLNB positivity yield if the procedure is performed."

The 2-GEP test and EIS can aid in the precise diagnosis of clinically indeterminate lesions and the 23-GEP test can be used when histopathology is equivocal. The 31-GEP test can enhance prognostic assessment beyond AJCC8 staging and improve clinical decision-making. J Drugs Dermatol. 2024;23(9):774-781. doi:10.36849/JDD.8365R1.

The i31-GEP identified patients with < 5% risk of SLN positivity who could safely forego SLNB. Combining the 31-GEP with clinicopathologic features for a precise risk estimate can help guide risk-aligned patient care decisions for SLNB to reduce the number of unnecessary SLNBs and increase the SLNB positivity yield if the procedure is performed.

The 31-GEP test has a limited impact on clinical management decisions and shows limited prognostic value.

The linkages of cancer cases from SEER registries with genomic test results obtained from molecular laboratories offer an effective approach for data collection in cancer surveillance. By providing de-identified data to the research community, the NCI's SEER Program enables scientists to investigate numerous research inquiries.

"Castle Biosciences...announced that it will present new data related to its DecisionDx-Melanoma and DecisionDx-UM tests at the 2024 American Society of Clinical Oncology (ASCO) Annual Meeting, being held May 31-June 4, 2024, in Chicago."

Under multivariable analysis, the 31-GEP was the only significant predictor of CNS metastasis, and CNS metastasis occurred early (1.5 yrs). Patients with early-stage I-II CM and a Class 2B result should be considered for CNS imaging to enable asymptomatic detection of CNS metastasis and, thus, improve survival relative to symptomatic CNS metastasis.

P=NA | N=760 | "Castle Biosciences...will share new data at the 20th European Association of Dermato-Oncology (EADO) Congress, being held April 4-6, 2024....Abstract: A-128:...This study evaluated the performance of a risk-stratification nomogram developed in Europe (Rentroia-Pacheco, et al, 2023) in a U.S. cohort of high-risk SCC patients (n=760) and the additional prognostic value provided by the DecisionDx-SCC test. In the study, the nomogram misclassified nine out of 10 tumors that metastasized as low risk. When the same tumors were tested using DecisionDx-SCC, 42% of those that the nomogram classified as low risk of metastasis were classified as high risk by the test, as well as 70% of all tumors that metastasized. These data demonstrate that DecisionDx-SCC improves the accuracy of risk assessment based solely on clinicopathological risk factors, leading to more appropriate risk-aligned management plans for patients with high-risk SCC."

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.

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

"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."

"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."

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)."

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.

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.

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."

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.

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.

No abstract available

No abstract available

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."

"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."

"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."

"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)."

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.

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.

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

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

In a population-based, clinically tested melanoma cohort, the 31-GEP stratified patients by their risk of dying from melanoma.

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."

"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."

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."

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.

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."

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.