TEST:

DecisionDx®-SCC

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."

ART guidance is not determined by the presence of specific clinicopathologic factors, with treated and untreated patients sharing the same risk factor profiles. cSCC risk determination based on NCCN recommendations for clinical factor assessment results in inconsistent use of ART. Including tumor biology-based prognostic information from the 40-GEP refines risk and identifies patients who are most appropriate and likely to benefit from ART, and those that can consider deferring ART.

However, the 40-GEP classified 70% of tumors missed by the nomogram as high-risk Class 2. These data demonstrate that 40-GEP improves risk stratification of NCCN high or very high-risk patients who were categorized as low-risk by this nomogram.

"Castle Biosciences, Inc...announced the publication of an expert consensus article in the Journal of Clinical and Aesthetic Dermatology (JCAD) related to the utility of its DecisionDx-SCC test in clinical decision-making regarding the use of ART. The consensus guidelines outline a recommended risk-based workflow that integrates DecisionDx-SCC and AJCC8 staging into current National Comprehensive Cancer Network (NCCN) guidelines to improve precision in ART recommendations based on which patients are at the highest risk for metastasis and most likely to benefit from treatment....A DecisionDx-SCC Class 2A or 2B result, indicating a higher or highest risk of metastasis, in each AJCC8 tumor stage serves as a high- or very high-risk feature for consideration in recommending ART."

The panel identified gaps in clinical practice in which 40-GEP testing has particular utility: in escalation of care for lower-stage patients with high-risk tumors; in de-escalation of care for patients for whom the risks of ART may outweigh the benefits; and in decision-making regarding elective radiation to the nodal basin. The expert panel developed a risk-based clinical workflow for ART in patients with cSCC, utilizing 40-GEP testing within NCCN management guidelines and AJCC-8 staging.

"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."

"Castle Biosciences...announced the publication of a new multi-center performance study of its DecisionDx-SCC risk stratification test. The study, published in Dermatology and Therapy and available here , analyzed the independent performance of DecisionDx-SCC from risk factors and traditional staging systems (i.e., Brigham and Women’s Hospital (BWH) and American Joint Committee on Cancer Staging Manual 8th Edition (AJCC8) staging), and demonstrated significantly improved predictive accuracy when the test’s results were integrated with the staging systems and National Comprehensive Cancer Network® (NCCN) guidelines to guide risk-appropriate treatment pathway decisions that can improve patient outcomes."

The 40-GEP test demonstrates accurate, independent, clinically actionable stratification of metastatic risk and improves predictive accuracy when integrated into risk classification systems. The improved accuracy of risk assessment when including tumor biology via the 40-GEP test ensures more risk-aligned, personalized patient management decisions.

Notably, 20% of all T1 cases had a 40-GEP Class 2A or 2B result, indicating the ability of the test to identify cases with a high biologic risk of developing metastasis that are considered low-risk cases by AJCC8/BWH staging. This analysis demonstrates clinicians' understanding of the test's appropriate application, allowing for improvement in the selection of risk-appropriate treatment options.

 The 40-GEP test provides accurate and independent prognostic information beyond standard staging systems that only incorporate pathologic data. Incorporation of GEP testing into national guidelines can help further stratify patients based on risk of metastasis and thus may improve morbidity and mortality. J Drugs Dermatol. 2023;22(12):54-60.   doi:10.36849/JDD.7691.

Potential limitations include a need for more comprehensive patient information and the cost of ART-related complications. Utilizing the 40-GEP test results to guide ART decision-making would result in material savings to Medicare.

High level evidence for appropriate risk prediction of occult regional nodal disease in cSCC is lacking. This prospective study of SLNB in high-risk cSCC is designed to quantify the risk of and clinicopathologic predictors of occult regional metastasis.

"Castle Biosciences...announced the publication of a new study1 in The Journal of Clinical and Aesthetic Dermatology (JCAD) which found that using its DecisionDx-SCC test to guide ART decisions for patients with SCC could result in substantial Medicare healthcare savings of up to approximately $972 million annually."

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 40-GEP test provides accurate and independent prognostic information beyond standard staging systems that only incorporate pathologic data. Incorporation of GEP testing into national guidelines can help further stratify patients based on risk of metastasis and thus may improve morbidity and mortality. J Drugs Dermatol. 2023;22(12): doi:10.36849/JDD.7691e.

"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."

Within this eligible for ART population, patients with Class 2A or 2B 40-GEP results have inferior rates of MFS, while Class 1 patients have 10% risk of metastasis) could be considered for adjuvant therapy.

P=NA | N=489 | "Castle Biosciences, Inc...will share new data demonstrating the ability of its DecisionDx^®-SCC test to identify node-negative cutaneous squamous cell carcinoma (SCC) patients at a higher risk of metastasis who may benefit from adjuvant radiation therapy (ART). The data will be shared in an oral presentation during the American Society for Radiation Oncology (ASTRO) 2023 Annual Meeting, being held Oct. 1-4 in San Diego....DecisionDx-SCC significantly stratified the cohort according to risk of metastasis, with metastasis-free survival (MFS) rates of 92.4%, 76.1% and 59.4% for patients with Class 1 (low biological risk of metastasis), Class 2A (moderate risk) and Class 2B (high risk) test results, respectively (p<0.0001). Cox regression analysis demonstrated a significant difference in Class 2A and 2B MFS compared to Class 1, with a 3.2-fold and 6.4-fold increase in metastasis, respectively (p<0.0001)."

In this expanded cohort, the 40-GEP provides objective information in situations where the distinction between poorly and moderately differentiated grading impact staging and, therefore, could enhance current risk-aligned patient management decisions.  Poster type: Poster Defense

P=N/A; Trial primary completion date: Oct 2023 --> Sep 2024

P=N/A; N=470; Not yet recruiting; Sponsor:Johns Hopkins University

P=NA | N=NA | "Castle Biosciences, Inc...announced new data demonstrating the ability of the DecisionDx^®-SCC test to identify cutaneous squamous cell carcinoma (cSCC) tumors at a biologically high risk of metastasis in a subset of patients considered to be at a low risk of metastasis by traditional staging (i.e., patients with T1 tumors under the American Joint Committee on Cancer Eighth Edition (AJCC8) and Brigham and Women’s Hospital (BWH) staging systems)....In the study, the DecisionDx-SCC test was able to significantly stratify three-year metastasis free survival rates within the AJCC8 and BWH T1 populations of the cSCC cohort. Approximately 70% of the AJCC8- and BWH-staged T1 tumors that metastasized were identified as being biologically high-risk by the DecisionDx-SCC test."

"Castle Biosciences, Inc...announced the publication of a paper in Clinical, Cosmetic and Investigational Dermatology highlighting a clinician-derived, real-world algorithm that provides a framework to incorporate DecisionDx^®-SCC test results into clinical practice within National Comprehensive Cancer Network (NCCN) guideline recommendations....In all three cases presented in the study, use of the algorithm incorporating DecisionDx-SCC test results led to no evidence of disease recurrence or metastasis post-treatment, based on the timing described in the study. The study findings support the use of DecisionDx-SCC test results within established guidelines to enable personalized, risk-aligned management of high-risk cSCC patients and the allocation of healthcare resources to patients at the highest risk of a poor outcome."

Discussion- In a novel cohort, the 40-GEP demonstrates consistent significant risk stratification in high-risk cSCC patients. The test provides independent value in predicting regional/distant metastasis and significantly enhances risk assessment accuracy over clinicopathologic staging alone.

The integration of 40-GEP with staging systems can improve the identification of cSCC patients at high risk of metastasis, potentially leading to improved care and outcomes, especially in the high-risk class 2B group.

The 40-GEP has demonstrated significant risk stratification in a high-risk cSCC immunosuppressed population. Use of the test provides improvement and greater clarity to risk-aligned treatment decisions by offering personalized metastatic risk assessment

The morphological features and patterns identified by cSCCnet are different from established histopathological high-risk criteria, indicating that this technology can enhance current practice. Although further validation in a prospective cohort is pending, this is an important step toward creating a risk stratification tool that can be incorporated into routine pathology workflows, significantly improving patient outcomes for this common cancer.

In a novel cohort, the 40-GEP demonstrates consistent significant risk stratification in high-risk cSCC patients. The test provides independent value in predicting regional/distant metastasis and significantly enhances risk assessment accuracy over clinicopathologic staging alone.

"Castle Biosciences, Inc...shared new performance data from a novel, multi-center, independent cohort demonstrating how the independent risk-stratification of DecisionDx®-SCC (the Company’s 40-gene expression profile (GEP) test) can significantly improve metastatic risk predictions by complementing current staging systems (AJCC81 and BWH2). Additionally, consistent with previous studies,3,4 DecisionDx-SCC independently and significantly stratified a novel cohort according to patients’ biologic metastatic risk (p<0.0001)."

"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."

No abstracts available

Clinicians are submitting clinical orders for the 40-GEP that are consistent with the intended use population for which the test was validated, signifying their understanding of the appropriate use of the test. As previously published, integrating 40-GEP results along with current assessment of a patient's metastatic risk may improve risk-appropriate treatment choices.

No abstracts available

"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."

"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."

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.

"Castle Biosciences, Inc...announced new data showing how the Company’s DecisionDx-SCC test can provide objective, independent and significant risk-stratification for cutaneous squamous cell carcinoma (cSCC) tumors with uncertainty in differentiation status. The data were shared in an oral presentation given at the American Society of Dermatopathology (ASDP) 59th Annual Meeting...The study data showed that: For 40% of patients in the sub-cohort, the BWH stage changed based upon the alteration of differentiation status, which could impact treatment decisions. DecisionDx-SCC independently and significantly stratified the sub-cohort according to metastatic risk; patients with a low-risk (Class 1) result had a statistically significant higher three-year metastasis free survival than both moderate-risk (Class 2A) and high-risk (Class 2B) patients (90.1% vs. 78.6% and 62.5%, respectively; p=0.02)."

The 40-gene expression profile (40-GEP) test was developed to augment metastatic risk prediction of high-risk cSCC patients and has been validated in two independent, multi-center studies involving over 1,000 patients. This study substantiates that the 40-GEP is appropriately utilized by clinicians and that the personalized risk-stratification results are impactful in guiding risk-aligned patient management.

"Real-world data involving healthcare providers who have clinical experience with DecisionDx-SCC indicates that patient management decisions can be impacted when the test’s results are considered....Overall, the study data support the positive impact that DecisionDx-SCC’s personalized, risk-stratification results can have on patient management plans, including: Helping avoid the overtreatment of patients: As an example, in Case 1 (which had the highest level of baseline overall management strategy), between 44 and 58% of clinicians who responded to the survey chose to de-escalate their overall management strategy and reduce their likelihood of performing adjuvant radiation therapy, SLNB, imaging (nodal assessment and surveillance) after receiving a low-risk (Class 1) test result, demonstrating the potential of the test to help avoid the overtreatment of patients."

P=NA | N=59 | "Castle Biosciences, Inc...announced new data from UTILISE (Clinical Utility and Health Outcomes Study), a prospective, multi-center, clinical utility study of DecisionDx^®-SCC, designed to capture the real-world impact of DecisionDx-SCC test results on the management of patients with cutaneous squamous cell carcinoma (cSCC) and one or more risk factors....In this analysis of Medicare-eligible patients with high-risk cSCC (n=59), clinicians indicated that the DecisionDx-SCC test result was the most influential factor impacting their management plans for 42% of the patients. Additionally, DecisionDx-SCC test results positively impacted patient management in over 80% of patients in the cohort, with clinicians reporting increased confidence in the recommended treatment plan (59%) and risk-aligned management changes based on the tests’ results (24%)."

No abstracts available