COMPANY:

Castle Biosci

"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."

"Castle Biosciences, Inc...announced a poster presentation on DecisionDx®-Melanoma at the recent 2022 Fall Clinical Dermatology Conference for PAs & NPs. The poster, titled 'Attitudes of Patients with Cutaneous Melanoma Towards Prognostic Testing Using Gene Expression Profiling,' shares results from a survey of 120 melanoma patients regarding prognostic testing with DecisionDx-Melanoma."

"Castle Biosciences, Inc...announced that an abstract demonstrating the ability of the Company’s DecisionDx®-Melanoma test to risk-stratify patients with cutaneous melanoma according to their survival likelihood will be available online during the upcoming 2022 American Society of Clinical Oncology (ASCO) Annual Meeting, being held virtually and in Chicago, June 3-7, 2022."

"Research to Prevent Blindness (RPB) and Castle Biosciences today announced that they are partnering to increase opportunities for medical students to gain research experiences, specifically in the field of ocular cancer. Ocular cancers, such as uveal melanoma (UM), are rare, affecting approximately 2,000 people per year in the U.S., but can be particularly devastating in terms of their effect on sight and on overall health. For these reasons, it is important to incentivize new research in this area and to bring new talent into the ocular cancer field."

"Castle Biosciences, Inc...announced new data showing that DecisionDx-SCC can independently risk-stratify patients with cutaneous squamous cell carcinoma...Kaplan-Meier analysis showed a statistically significant difference in metastasis-free survival (MFS) rates between DecisionDx-SCC Class 1, Class 2A and Class 2B results (p<0.0001, log-rank), demonstrating the ability of the test to risk-stratify patients according to their biologic metastatic risk. As demonstrated by univariate Cox regression analysis, DecisionDx-SCC Class 2A, Class 2B, traditional high-risk clinicopathologic risk factors, American Joint Committee on Cancer Eighth Edition (AJCC8) T3/T4 stages and Brigham and Women’s Hospital (BWH) T2b/T3 stages were all statistically associated with metastatic risk."

"Castle Biosciences, Inc...announced that for the second year, it is a national sponsor of The Sun Bus, a mobile clinic that provides free skin checks and sun safety education across numerous U.S. states...The Sun Bus plans to provide over 360 hours of free skin screening services and sun safety education at more than 50 locations across Texas, Georgia, Iowa, Kansas, Missouri, Wyoming, Colorado, New Mexico and Arizona during its expanded and extended 2022 tour. This includes a stop at Castle’s headquarters in Friendswood, Texas, on Monday, May 16."

"Castle Biosciences, Inc. (Nasdaq: CSTL), a company improving health through innovative tests that guide patient care, today announced that its current U.S. Federal Supply Schedule (FSS) contract with the Veterans Health Administration (VHA) has been expanded to include coverage for the Company’s entire skin cancer test portfolio, effective as of April 15, 2022...The VHA is a component of and implements the healthcare program for U.S. veterans through the U.S. Department of Veterans Affairs (VA). Castle’s current five-year FSS contract went into effect on Aug. 15, 2021, and included coverage for the Company’s DecisionDx®-Melanoma gene expression profile test. Effective April 15, 2022, the expanded contract includes coverage for the remaining four tests in Castle’s dermatologic cancer test portfolio: DecisionDx®-SCC, DecisionDx® DiffDx™-Melanoma, myPath® Melanoma and DecisionDx®-CMSeq."

"Castle Biosciences, Inc...announced new data from a recent study in which patients tested with DecisionDx®-Melanoma in addition to traditional clinicopathologic factors had improved survival compared to patients with only traditional clinicopathologic factors available to determine their treatment and follow-up plan. The study is part of the Company’s ongoing collaboration with the National Cancer Institute (NCI) to link DecisionDx®-Melanoma testing data with data from the Surveillance, Epidemiology and End Results (SEER) Program’s registries on cutaneous melanoma (CM) cases. The data will be shared in a poster presentation at the 18th European Association of Dermato Oncology (EADO) Congress, being held virtually and in Seville, Spain, April 21-23, 2022."

"Castle Biosciences, Inc...announced that data on its portfolio of skin cancer gene expression profile (GEP) tests will be shared via poster presentations during the 18th European Association of Dermato Oncology (EADO) Congress, being held virtually and in Seville, Spain, April 21-23, 2022."

"Castle Biosciences, Inc...today announced upcoming presentations on two of its skin cancer gene expression profile (GEP) tests at the 2022 American Academy of Dermatology (AAD) Annual Meeting, being held in Boston, March 25-29, 2022."

"Castle Biosciences, Inc...announced new data further demonstrating the performance of DecisionDx®-Melanoma and i31-SLNB to provide improved risk prediction of sentinel lymph node (SLN) positivity, compared to using T-stage factors alone, in patients with cutaneous melanoma. The data will be shared in a poster presentation at the Society of Surgical Oncology (SSO) 2022 International Conference on Surgical Cancer Care, being held in Dallas and virtually, March 9-12, 2022."

"Castle Biosciences, Inc...announced a collaboration with the National Cancer Institute (NCI) to link DecisionDx®-Melanoma testing data with data from the Surveillance, Epidemiology and End Results (SEER) Program’s registries on cutaneous melanoma (CM) cases...CM cases in the SEER registries that were diagnosed between 2013-2018 were linked with DecisionDx-Melanoma results and additional clinicopathologic information from patients tested between 2013-2018. The Company expects to continue collaborating with the NCI to link the SEER registries’ CM cases diagnosed post-2018 with DecisionDx-Melanoma test results."

"Castle Biosciences, Inc...will present data highlighting its portfolio of skin cancer tests at Maui Derm for Dermatologists 2022, being held Jan. 24-28, 2022, in Maui, Hawaii...Title: Integrating the 31-gene expression profile and clinicopathologic data to determine the risk of sentinel lymph node positivity and recurrence-free survival in cutaneous melanoma...Title: Appropriate utilization of the prognostic 40-gene expression profile (40-GEP) test for cutaneous squamous cell carcinoma (cSCC) demonstrated by clinical reports and physician evaluation of real-world cases."

"Castle Biosciences, Inc...announced the publication of clinical performance study data demonstrating that DecisionDx®-SCC provides significant and independent prognostic value for stratifying metastasis risk in patients with cutaneous squamous cell carcinoma (SCC) with one or more risk factors (high risk). The study, titled 'Enhanced Metastatic Risk Assessment in Cutaneous Squamous Cell Carcinoma with the 40-Gene Expression Profile Test' is available online in Future Oncology."

"Castle Biosciences...announced the publication of a study demonstrating that the combined application of DecisionDx®-UM, DecisionDx®-PRAME and DecisionDx®-UMSeq allows for highly accurate analysis of RNA and DNA from a single biopsy sample for patients with uveal melanoma (UM)...The study titled, 'Analytical validation and performance of a 7-gene next-generation sequencing panel in uveal melanoma' was recently published in the peer-reviewed journal Ocular Oncology and Pathology."

P=NA, N=328; "Patients receiving a DecisionDx-SCC Class 2B result had a high metastasis rate of 58.8%, suggesting that this set of patients may benefit from additional adjuvant treatment after MMS...Univariate and multivariate Cox regression analysis showed that DecisionDx-SCC provides independent prognostication for metastasis (hazard ratio of 15.12 and a p value of <0.001 for multivariate Class 2B results) when compared to traditional high-risk clinicopathological factors, such as presence of perineural invasion, poor differentiation and deep invasion."

"Castle Biosciences, Inc...announced the publication of a study of patients with stage I-III cutaneous melanoma. Data demonstrated that DecisionDx®-Melanoma is a significant independent predictor of metastatic recurrence...The study, titled 'The 31-gene expression profile stratifies recurrence and metastasis risk in patients with cutaneous melanoma,' analyzed 438 patients who were tested with DecisionDx-Melanoma as part of their clinical care."

"Castle Biosciences, Inc...announced the publication of a study validating performance of a novel algorithm designed to integrate the DecisionDx®-Melanoma gene expression profile (GEP) test with clinicopathologic features (i31-GEP SLNB) to determine sentinel lymph node biopsy (SLNB) positivity risk in patients with cutaneous melanoma...The article, titled 'Integrating 31-Gene Expression Profiling with Clinicopathologic Features to Optimize Cutaneous Melanoma Sentinel Lymph Node Metastasis Prediction,' was published in the peer-reviewed journal JCO® Precision Oncology..."

"Castle Biosciences, Inc...announced its agreement with ModMed to establish an interface with ModMed’s electronic health records system, EMA®. The interface is designed to enable dermatologic clinicians to order Castle’s DecisionDx® skin cancer tests from directly within a patient’s medical record in EMA...Castle’s full suite of skin cancer tests will be available to order within EMA: DecisionDx®-Melanoma for cutaneous melanoma, DecisionDx®-SCC for cutaneous squamous cell carcinoma and the Company’s Comprehensive Diagnostic Offering for difficult-to-diagnose melanocytic lesions (comprised of myPath® Melanoma and DecisionDx® DiffDx™-Melanoma)."

"Castle Biosciences, Inc...announced that the DecisionDx®-Melanoma integrated test result (ITR) now includes i31-GEP for Risk of Recurrence (i31-ROR). Designed to improve the precision of treatment plans for better patient care, the i31-ROR predicts patient-specific five-year outcomes for melanoma-specific survival (MSS), distant metastasis-free survival (DMFS) and recurrence-free survival (RFS)."

"Castle Biosciences, Inc...announced recent poster presentations on the Company’s suite of dermatologic cancer gene expression profile (GEP) tests, as well as a poster describing the study design for its inflammatory skin disease pipeline initiative at the 2021 Fall Clinical Dermatology Conference, held Oct. 21-24."

"Castle Biosciences, Inc...announced that it has been awarded a five-year U.S. Federal Supply Schedule (FSS) contract from the Veterans Health Administration (VHA) for its DecisionDx®-Melanoma gene expression profile test...The contract became effective on Aug. 15, 2021, and provides greater access to DecisionDx®-Melanoma for veterans being treated through the VHA, the largest integrated health care system in the U.S., as well as active-duty service members and their families seeking medical treatment through the Military Health System (MHS)."