Additionally, an expert physician panel convened by EndoscopyNow will host a product theater on Sunday, May 4, at 2:45 p.m. Pacific Time, titled, “The Time is Now: A Clinical Practice Model to Help Prevent Progression from Barrett's to EAC” FRIENDSWOOD, Texas, May 02, 2025 (GLOBE NEWSWIRE) -- Castle Biosciences, Inc. (Nasdaq: CSTL), a company improving health through innovative tests that guide patient care, will share new data on its TissueCypher Barrett’s Esophagus test via two posters at the Digestive Di ...

Patients identified as low risk by DecisionDx-Melanoma had a 2.8% sentinel lymph node (SLN) positivity rate, well below the National Comprehensive Cancer Network® (NCCN) guidelines’ 5% threshold to forgo sentinel lymph node biopsy (SLNB) surgery FRIENDSWOOD, Texas, April 30, 2025 (GLOBE NEWSWIRE) -- Castle Biosciences, Inc. (Nasdaq: CSTL), a company improving health through innovative tests that guide patient care, today announced the publication of a new study in Cancer Diagnosis & Prognosis demonstrating ...

FRIENDSWOOD, Texas, April 25, 2025 (GLOBE NEWSWIRE) -- Castle Biosciences, Inc. (Nasdaq: CSTL), a company improving health through innovative tests that guide patient care, will share new research intended to improve the care of patients with cutaneous and uveal melanoma (CM and UM, respectively) via poster presentations at the American Association for Cancer Research® (AACR) Annual Meeting 2025, being held April 25-30 in Chicago. "At Castle Biosciences, our commitment to advancing care for melanoma patient ...

FRIENDSWOOD, Texas, April 14, 2025 (GLOBE NEWSWIRE) -- Castle Biosciences, Inc. (NASDAQ:CSTL), a company improving health through innovative tests that guide patient care, today announced that it will release its financial results for the first quarter ended March 31, 2025, after the close of market on Monday, May 5, 2025. Company management will host a conference call and webcast to discuss its financial results at 4:30 p.m. Eastern time on the same day. Conference Call and Webcast DetailsA live webcast of ...

FRIENDSWOOD, Texas, April 08, 2025 (GLOBE NEWSWIRE) -- Castle Biosciences, Inc. (NASDAQ:CSTL), a company improving health through 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 ...

Company Overview - Castle Biosciences, Inc. is a diagnostics company focused on improving health through innovative tests that guide patient care [4] - The company has a portfolio that includes tests for skin cancers, Barrett's esophagus, mental health conditions, and uveal melanoma, with ongoing research for additional tests [5] Awards and Recognition - Castle Biosciences has received the Top Workplaces USA Award for the fourth consecutive year, ranking 30th among 358 participating U.S. companies with 500-999 employees [1] - The award is based on employee feedback collected through a third-party engagement survey, with Castle achieving a participation rate of 95% and an engagement score of 85%, both exceeding industry benchmarks [2] Leadership and Culture - The CEO of Castle Biosciences emphasized the importance of a people-first culture that values and empowers employees, which is reflected in the company's recognition [2] - Energage, the organization behind the award, highlighted that companies earning this recognition are seen as having a strong employee voice and culture, which is crucial in today's market [3]

Core Insights - Castle Biosciences' DecisionDx-Melanoma test effectively identifies patients with less than 5% risk of sentinel lymph node (SLN) positivity, allowing them to safely forgo sentinel lymph node biopsy (SLNB) [1][2][3] - The DECIDE study demonstrated that all patients with a low-risk DecisionDx-Melanoma test result (Class 1A) were recurrence-free, indicating the test's reliability in predicting long-term outcomes [1][2][3] - The test significantly influences clinical decision-making, with 85% of SLNB decisions being affected by its results, thereby reducing unnecessary procedures and associated costs [2][3] Company Overview - Castle Biosciences, Inc. (Nasdaq: CSTL) focuses on innovative diagnostic tests that enhance patient care, with a portfolio that includes tests for skin cancers and other conditions [5][6] - The DecisionDx-Melanoma test has been ordered approximately 191,800 times for patients diagnosed with cutaneous melanoma, reflecting its widespread adoption and clinical relevance [4][6] - The company aims to transform disease management by prioritizing the needs of patients, clinicians, employees, and investors [5]

Core Insights - Castle Biosciences, Inc. will present data on the DecisionDx-Melanoma test at the 11th World Congress of Melanoma and the 21st European Association of Dermato-Oncology Congress, highlighting its role in risk stratification for patients with stage IIB-IIC cutaneous melanoma [1][2] Group 1: DecisionDx-Melanoma Test - The DecisionDx-Melanoma test provides significant biological insights that enhance traditional staging, allowing clinicians to tailor surveillance and treatment plans based on individual risk of metastasis [2] - The test has been shown to improve melanoma outcomes by identifying patients who may benefit from intensified monitoring and adjuvant therapy [2][6] - DecisionDx-Melanoma has been ordered over 191,000 times for patients diagnosed with cutaneous melanoma, demonstrating its clinical value supported by more than 50 peer-reviewed studies [6][7] Group 2: Research Findings - A study presented at EADO indicates that DecisionDx-Melanoma effectively stratifies melanoma-specific survival and overall survival in patients with stage IIB-IIC cutaneous melanoma, with a p-value of less than 0.001 [5] - Another study shows that the test can identify patients with localized cutaneous melanoma at high risk of CNS metastasis within the first three years post-diagnosis, with a hazard ratio of 9.21 [5] - The DecisionDx-Melanoma Class 2B result is a significant predictor of CNS metastasis, emphasizing the need for more frequent imaging surveillance for high-risk patients [5]

Core Insights - Castle Biosciences presented new data on its risk-stratification tests, DecisionDx-SCC and DecisionDx-Melanoma, at the NCCN 2025 Annual Conference, highlighting their significant prognostic capabilities in enhancing risk stratification for skin cancer patients [1][2] Group 1: DecisionDx-SCC - A study involving 1,412 high-risk squamous cell carcinoma (SCC) patients demonstrated that integrating DecisionDx-SCC with Brigham & Women's Hospital (BWH) staging significantly improves metastatic risk prediction, with a p-value of less than 0.001 [4] - The combination of DecisionDx-SCC with BWH staging resulted in nearly a two-fold decrease in metastatic risk for Class 1 (low risk) patients and over a five-fold increase in risk for Class 2B (highest risk) patients in lower-stage NCCN High-Risk categories [4][9] - DecisionDx-SCC is a 40-gene expression profile test that categorizes patients into risk classes to inform management decisions, showing independent predictive value when integrated with existing prognostic methods [9] Group 2: DecisionDx-Melanoma - New validation data for DecisionDx-Melanoma indicated its effectiveness in predicting mortality in a real-world cohort of nearly 7,000 early-stage cutaneous melanoma patients, identifying individuals at higher risk than traditional AJCC8 staging [5][7] - The test demonstrated significant independent risk-stratification capabilities, aiding in the identification of patients who may benefit from enhanced surveillance and management strategies [7][10] - DecisionDx-Melanoma has been ordered over 191,000 times for patients diagnosed with cutaneous melanoma, supporting its clinical value through extensive peer-reviewed studies [10] Group 3: Company Overview - Castle Biosciences is a diagnostics company focused on innovative tests that guide patient care, with a portfolio that includes tests for skin cancers and other conditions [11][12] - The company aims to transform disease management by prioritizing the needs of patients, clinicians, employees, and investors [11]

Financial Data and Key Metrics Changes - In Q4 2024, the company reported revenue of $86.3 million, a 31% increase year-over-year, and total revenue for the full year 2024 reached $332.1 million, reflecting a 51% increase compared to 2023 [10][31] - The company achieved a gross margin of 76.2% in Q4 2024, down from 77.8% in Q4 2023, while the full year gross margin improved to 78.5% from 75.4% in 2023 [33] - Net income for Q4 2024 was $9.6 million compared to a net loss of $2.6 million in Q4 2023, and for the full year, net income was $18.2 million compared to a net loss of $57.5 million in 2023 [38][39] Business Line Data and Key Metrics Changes - The dermatology business, including DecisionDx-Melanoma and DecisionDx-SCC, grew by 17% in 2024 compared to 2023, with DecisionDx-Melanoma reporting 36,008 test reports, an 8% increase [12][21] - DecisionDx-SCC saw a significant increase in test report volume, delivering 16,348 reports in 2024, a 43% increase from 2023 [21] - TissueCypher test reports surged to 20,956 in 2024, representing a 130% growth compared to 9,100 in 2023 [26] Market Data and Key Metrics Changes - The addressable market for DecisionDx-Melanoma is estimated at approximately 130,000 patients, with the company achieving about 28% market penetration by the end of 2024 [13] - For DecisionDx-SCC, the addressable market is around 200,000 patients, with an 8% market penetration [22] - The addressable market for TissueCypher is estimated at 415,000 patients per year in the U.S., with a 5% market penetration by the end of 2024 [28] Company Strategy and Development Direction - The company plans to focus on strong execution and sound capital allocation strategies, including exploring strategic opportunities for growth [42][43] - There is an emphasis on expanding the commercial team and increasing awareness and education regarding the company's tests, particularly TissueCypher [28] - The company is also considering reallocating resources towards the DecisionDx-Melanoma test in response to potential reimbursement challenges for DecisionDx-SCC [60][84] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in entering 2025 with financial and operational strength, driven by a commitment to innovation and improving patient outcomes [44] - The anticipated loss of Medicare coverage for DecisionDx-SCC is expected to impact revenue, with guidance for 2025 total revenue projected between $280 million to $295 million [32] - Management noted that while they expect some volume growth for DecisionDx-Melanoma in 2025, the first quarter may see flat or slightly down volumes due to typical seasonality [21] Other Important Information - The company ended 2024 with cash, cash equivalents, and marketable securities totaling $293.1 million, which is expected to support long-term growth initiatives [11][42] - Adjusted EBITDA for the full year 2024 was $75 million, a significant improvement from a negative $4.4 million in 2023 [40] Q&A Session Summary Question: Concerns about DecisionDx-Melanoma adoption in academic centers - Management noted that despite some hesitance in academic centers, there was substantial growth in new first-time ordering clinicians for the melanoma test [46][47] Question: Update on atopic dermatitis gene expression profile test - Management indicated that they expect to launch the test in late 2025, pending successful validation study results, and will provide clarity on reimbursement strategies in the coming months [49][52] Question: Commercial strategy for DecisionDx-SCC amid reimbursement issues - Management stated that they would likely continue offering the test to patients and clinicians while exploring options to regain Medicare coverage [58][60] Question: Strategic opportunities for capital allocation - Management is considering both existing and new verticals for investment, focusing on enhancing current commercial efforts and exploring external opportunities [63][65] Question: Adjusted EBITDA expectations for 2025 - Management reiterated that they expect to be adjusted EBITDA positive for the year but did not provide specific guidance [66] Question: Residual payments from non-Medicare payers for DecisionDx-SCC - Management indicated that there are not significant commercial payments for DecisionDx-SCC at this time [71] Question: M&A market in diagnostics - Management acknowledged that while there are many assets in the diagnostic space, they maintain a disciplined approach to acquisitions [73] Question: SG&A modeling for 2025 - Management confirmed that there would be some expansions to the TissueCypher salesforce, but no sweeping changes to the overall salesforce structure [75] Question: Impact of hurricanes and holidays on Q4 performance - Management noted that it is difficult to predict when patients will be rescheduled, but they expect typical seasonality for Q1 [78][79]