COMPANY:

Castle Biosci

"Castle Biosciences, Inc...announced it has signed a definitive agreement to acquire Capsulomics, Inc., d/b/a Previse. Previse is a gastrointestinal health company with a primary focus on chronic acid reflux related diseases, including esophageal cancer. The terms of the agreement are undisclosed....The transaction is expected to close in the coming weeks, subject to the customary closing conditions."

"Castle Biosciences, Inc...today announced its achievement of surpassing a significant milestone of 200,000 DecisionDx-Melanoma clinical test orders. DecisionDx-Melanoma is a 31-gene expression profile test that provides comprehensive, personalized results designed to improve risk-aligned management decisions for patients with stage I-III cutaneous melanoma."

"Castle Biosciences, Inc...today announced the publication of a new study in Cancer Diagnosis & Prognosis demonstrating that DecisionDx-Melanoma outperforms both American Joint Committee on Cancer (AJCC) staging and the CP-GEP test (clinicopathological and gene expression profiling model) in identifying patients at low risk of SLN positivity who may consider forgoing SLNB surgery."

"Castle Biosciences, Inc...will share new data on its TissueCypher Barrett’s Esophagus test via two posters at the Digestive Disease Week® (DDW 2025) Annual Meeting, being held May 3-6 in San Diego. In addition to the product theater, Castle is collaborating with renowned gastrointestinal (GI) experts and the American Society for Gastrointestinal Endoscopy (ASGE) on several educational sessions highlighting the use of TissueCypher to improve the risk stratification and subsequent management of patients with Barrett’s esophagus (BE)."

"Castle Biosciences...innovative tests that guide patient care, is supporting key educational programs and initiatives throughout the month of April in recognition of Esophageal Cancer Awareness Month. The Company is proudly collaborating with the Esophageal Cancer Action Network (ECAN), the American Foregut Society (AFS) and The Gut Doctor PodcastLLC to promote esophageal cancer prevention, education and advocacy."

"Castle Biosciences...will share data via two poster presentations at the 11th World Congress of Melanoma and 21st European Association of Dermato-Oncology (EADO) Congress, being held April 3-5, 2025, in Athens, Greece. The posters demonstrate the ability of the DecisionDx-Melanoma test to guide more informed, risk-aligned management decisions through the precise risk-stratification of patients with melanoma."

"Castle Biosciences, Inc...today announced the recent publication of two papers in the World Journal of Surgical Oncology and Cancer Medicine sharing reports from the prospective, multicenter DECIDE study demonstrating the significant impact of the Company’s DecisionDx-Melanoma test on SLNB decision-making for patients with melanoma."

"Castle Biosciences...will share new data on its risk-stratification tests for patients with skin cancers, DecisionDx-SCC and DecisionDx-Melanoma, via two poster presentations at the NCCN 2025 Annual Conference, being held March 28-30 in Orlando, Florida."

"Castle Biosciences, Inc...will share data supporting its dermatologic portfolio of tests for skin cancer, DecisionDx-SCC, DecisionDx®-Melanoma and MyPath® Melanoma, through poster presentations at the annual Maui Derm Hawaii meeting, being held Jan. 20-24, 2025, in Maui, Hawaii."

"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."

"Castle Biosciences...will share new data highlighting the clinical performance of its DecisionDx-Melanoma and MyPath Melanoma tests at the American Society of Dermatopathology (ASDP) 61 st Annual Meeting, being held Nov. 7-10, in Chicago."

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."

"Castle Biosciences, Inc...today announced the publication of two recent studies that provide further support for the clinical need of its MyPath® Melanoma gene expression profile (GEP) test, designed to aid in providing an accurate diagnosis for ambiguous melanocytic lesions of uncertain malignant potential."

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."

"Castle Biosciences, Inc...today announced that it will present new data related to its DecisionDx-Melanoma and DecisionDx® -UM tests for patients with cutaneous melanoma (CM) and uveal melanoma (UM), respectively, at the 21st International Congress of the Society for Melanoma Research (SMR), taking place Oct. 10-13, 2024, in New Orleans."

P=NA | N=954 | "The data will be shared in an oral presentation at the American Society for Radiation Oncology (ASTRO) 2024 Annual Meeting....Patients with T1 tumors had similar metastasis-free survival (MFS) rates regardless of immune status yet were further stratified by their DecisionDx-SCC test result (3-year MFS: Class 1 test result: 96.9% vs. Class 2A/2B test result: 88.6%, p<0.001). Immune suppressed patients with T2a tumors had significantly worse MFS than immune competent patients with T2a tumors (71.4% vs. 91.2%, p<0.001). DecisionDx-SCC further stratified immune suppressed patients with T2a tumors into those with more favorable (Class 1 test result; 3-yr MFS of 83%) and less favorable survival (Class 2A/2B test result; 3-yr MFS of 57%)."

"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."

P=NA | N=399 | "Castle Biosciences, Inc...today announced the publication of a new study in Future Oncology further substantiating use of its DecisionDx-SCC test in guiding patient selection and decision-making related to the use of ART in patients with high-risk SCC based on the ability of the test to identify patients likely to benefit from treatment...'In this study, we were successful in validating, in an independent SCC patient cohort, that DecisionDx-SCC can objectively inform these challenging decisions by identifying patients for whom ART would be beneficial, as well as those who may be best served by avoiding it. In the study, a novel, independent cohort of patients with high-risk SCC tumors (399 patients; 423 tumors) from two academic centers were tested using DecisionDx-SCC and analyzed for five-year metastasis-free survival and projected time to metastasis."

"Castle Biosciences, Inc...today announced that its executive management is scheduled to present a company overview at the Canaccord Genuity 44 th Annual Growth Conference on Tuesday, Aug. 13, 2024, at 12:30 p.m. Eastern time."

"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."

P=NA | N=920 | "Castle Biosciences...announced the publication of a study in the International Journal...demonstrating the ability of the DecisionDx-SCC test to identify high-risk cutaneous squamous cell carcinoma (SCC) patients at the highest risk of metastasis who will benefit the most from ART to reduce metastatic disease progression, as well as high-risk patients who the test identified as having a lower risk of metastasis who may consider deferring treatment....Key findings of the study (n=920 patients) include: The DecisionDx-SCC test identified patients projected to receive the greatest benefit from ART to reduce metastatic disease progression. Patients with a Class 2B (highest metastatic risk) test result who were treated with ART had 50% higher MFS rates, on average, than Class 2B patients who did not receive ART at five years post-diagnosis."

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+."

P=NA | N=417 | "Castle Biosciences, Inc...announced that new data supporting the utility of its DecisionDx-SCC test in patients with high-risk cutaneous squamous cell carcinoma (SCC) tumors located on the head and neck (H&N) will be shared at the 56th American College of Mohs Surgery (ACMS) Annual Meeting, being held May 2-5 in Phoenix....DecisionDx-SCC testing of the tumor tissue before removal significantly increased the prediction accuracy of metastatic events, when used alone and when combined with National Comprehensive Cancer Network (NCCN) guidelines, Brigham and Women’s Hospital (BWH) staging or American Joint Committee on Cancer Staging Manual, 8th Edition (AJCC8) staging, to better guide risk-aligned patient care decisions regarding metastatic surveillance or the use of adjuvant treatments like radiation."

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."