COMPANY:

Castle Biosci

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."

"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, 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."

"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."

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)."

"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."

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 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."

"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)."

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)."

"Castle Biosciences, Inc...announced that the Company has received its Clinical Laboratory Permit from the New York State Department of Health for its laboratory in Pittsburgh."

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."

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."

"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."

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."

"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."

"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."

"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."

"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."

"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."

"Castle Biosciences, Inc...today announced that the Accreditation Committee of the College of American Pathologists (CAP) has accredited its clinical laboratory facility in Pittsburgh. This achievement follows a recent on-site inspection as part of the CAP’s Laboratory Accreditation Program."

"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)."

"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)."

"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=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."

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%)."

"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."

"Castle Biosciences, Inc....announced a recent poster presentation showcasing the performance of its diagnostic gene expression profile (GEP) test, DiffDx^®-Melanoma....In the case study presented during the College of American Pathologists 2022 (CAP22) Annual Meeting, DiffDx-Melanoma supported the need to perform a local excision on a difficult-to-diagnose melanocytic lesion after clinicopathological correlation was not achieved by dermoscopy, reflectance confocal microscopy and/or histopathological assessment alone."

"Castle Biosciences, Inc...is presenting data highlighting its portfolio of skin cancer gene expression profile (GEP) tests at the 2022 American Society for Dermatologic Surgery (ASDS) Annual Meeting, being held Oct. 6-10 in Aurora, Colorado, including new data highlighting impactful changes in risk-aligned patient management strategies after clinicians received DecisionDx^®-SCC test results....Study highlights: 97% of respondents were at least somewhat familiar with or had used the DecisionDx-SCC test; Several National Comprehensive Cancer Network (NCCN) high- or very-high risk factors, such as perineural involvement, lymphatic or vascular involvement, poor differentiation and more, that the clinicians believed were the most influential in the development of metastasis were also considered reasons to use DecisionDx-SCC....42% of Mohs surgeons reported increased confidence in management decisions when DecisionDx-SCC test results were provided."

"Castle Biosciences, Inc...announced the publication of a study in the Journal of the American Academy of Dermatology validating the performance of DecisionDx^®-Melanoma’s proprietary algorithm, i31-ROR....Study highlights: In the study, DecisionDx-Melanoma’s i31-ROR algorithm identified patients at the highest and lowest risk for recurrence or metastasis; patients with a low-risk i31-ROR result had significantly higher RFS (91% vs. 45%, P<0.001), DMFS (95% vs. 53%, P<0.001) and MSS (98% vs. 73%, P<0.001) than patients with a high-risk i31-ROR result....The i31-ROR also had higher sensitivity and higher negative predictive value (NPV) for RFS, DMFS and MSS than SLN status alone (sensitivity of i31-ROR vs. SLN status alone: RFS (66% vs. 46%), DMFS (78% vs. 49%) and MSS (71% vs. 57%); NPV of i31-ROR vs. SLN status alone: RFS (93% vs. 89%), DMFS (97% vs. 93%) and MSS (98% vs. 97%))."

"Castle Biosciences, Inc...provided a proposed framework of the Company’s diagnostic gene expression profile (GEP) tests, MyPath^® Melanoma and DiffDx^®-Melanoma, for use in clinical practice to help achieve personalized management and treatment plans....Additionally, the poster shares impactful data demonstrating how benign and malignant diagnostic GEP test results can alter patient management plans, including: a 76.7%-80.5% reduction in excisions for patients with benign test results, and a 75% increase in excisions for patients with malignant results; and; 74.1% of dermatologists reducing office visits for patients with benign test results, and 95.2% of dermatologists increasing office visits for patients with malignant results."

"Castle Biosciences, Inc...announced an upcoming presentation on DecisionDx®-Melanoma, the Company’s risk stratification gene expression profile (GEP) test, at the 2022 American Academy of Dermatology (AAD) Innovation Academy, being held in Vancouver, Canada, July 21-24...Integrating a patient’s tumor biology and their clinicopathologic features, DecisionDx-Melanoma provides comprehensive and actionable results to guide risk-aligned patient care."

"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."

"Castle Biosciences, Inc...announced new data demonstrating the clinical value of the Company’s tests for skin cancer in guiding more informed disease management decisions. Data on each of Castle’s skin cancer tests, as outlined below, was shared during the recent Society of Dermatology Physician Assistants (SDPA) Annual Summer Dermatology Conference 2022."