FRIENDSWOOD, Texas, Dec. 17, 2025 (GLOBE NEWSWIRE) -- Castle Biosciences, Inc. (Nasdaq: CSTL), a company improving health through innovative tests that guide patient care, today announced new data from the largest prospective, multicenter study to date comparing next-generation sequencing (NGS)-based gene mutation analysis with the combination of DecisionDx-UM and Preferentially Expressed Antigen in Melanoma (PRAME) gene expression for predicting outcomes in patients with uveal melanoma (UM). The study, tit ...

Core Insights - Castle Biosciences, Inc. announced a systematic review and meta-analysis demonstrating that the TissueCypher® Barrett's Esophagus test provides clinically validated risk stratification for patients with Barrett's esophagus, outperforming traditional pathology or clinical factors in identifying patients at increased risk of developing esophageal cancer [1][2]. Group 1: Study Findings - The systematic review and meta-analysis consolidated data from six studies, confirming that TissueCypher consistently identifies patients at greater risk of progression to high-grade dysplasia (HGD) or esophageal adenocarcinoma (EAC) [2]. - The study represents the most comprehensive validation of the TissueCypher test to date, reinforcing its value as an evidence-based tool for risk stratification in Barrett's esophagus [3][5]. - TissueCypher has been shown to be the strongest independent predictor of progression compared to traditional histopathological risk assessment, with high-risk results indicating patients are 6.7 times more likely to progress to HGD or EAC within five years than those with low-risk results [7][9]. Group 2: Clinical Implications - The findings support personalized, risk-aligned patient management aimed at preventing cancer, allowing physicians to identify which patients may benefit from earlier intervention and those who can continue routine surveillance [3][5]. - Patients with high or intermediate-risk results had an annual progression rate of 2.8%, while those with high-risk results had a rate of 5.6% per year, both exceeding the typical 1.7% annual progression rate for patients with low-grade dysplasia [9]. Group 3: Test Overview - TissueCypher is a precision medicine test designed to predict a patient's personalized risk of progression from Barrett's esophagus to high-grade dysplasia or esophageal adenocarcinoma, indicated for patients with non-dysplastic BE, indefinite for dysplasia, or low-grade dysplasia [6]. - The test utilizes an AI-driven spatialomics approach to identify molecular signatures that precede dysplasia development, enabling earlier identification and management of patients at increased risk of cancer [7].

Expert panel offers data-driven guidance for integrating DecisionDx-Melanoma into clinical decision-making for patients with melanomaFRIENDSWOOD, Texas, Dec. 09, 2025 (GLOBE NEWSWIRE) -- Castle Biosciences, Inc. (Nasdaq: CSTL), a company improving health through innovative tests that guide patient care, today announced the publication of an independent expert consensus paper titled “31-Gene Expression Profiling for Cutaneous Melanoma: An Expert Consensus Panel,” which endorses the Company’s DecisionDx-Melan ...

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Summary of Castle Biosciences FY Conference Call Company Overview - Castle Biosciences is a molecular diagnostics company focused on proprietary algorithm-driven tests aimed at improving patient management and outcomes [2][3] Industry and Market Insights - The company operates primarily in the dermatology and gastroenterology sectors, with tests designed for conditions such as melanoma, atopic dermatitis, and Barrett's esophagus [5][7] - The total addressable market (TAM) for their tests is significant, with estimates of $540 million for melanoma tests, $820 million for high-risk cutaneous squamous cell carcinoma, and $1 billion for Barrett's esophagus [9][10][11] Financial Performance - In Q3 2025, Castle Biosciences reported a revenue growth of 36% year-over-year, matching the volume growth [2] - Adjusted gross margins decreased to 77% from 82% due to the loss of coverage for squamous cell carcinoma tests [3] - The company ended the quarter with cash and cash equivalents of $287 million, indicating a strong balance sheet [3] Product Developments - The company launched a new test called Advance ADTX for guiding systemic therapy selection in patients with moderate to severe atopic dermatitis [4] - The DecisionDx-SCC test demonstrated the ability to predict the likelihood of response to adjuvant radiation therapy in high-risk cutaneous squamous cell carcinoma patients [6] - Ongoing collaboration with SciBase aims to predict flares in atopic dermatitis patients using electrical impedance spectroscopy technology [7] Clinical Study Findings - A large prospective observational study validated a 487 gene expression profile test for atopic dermatitis, identifying two key profiles: TH2 molecular profile and JAK inhibitor responder profile [12][19] - Patients with a JAK inhibitor responder profile had a 45% chance of achieving EASI-90 (90% clearance) when treated with JAK inhibitors, compared to only 8.3% with TH2 biologic therapy [19] Market Research and Adoption - Approximately 78% of clinicians surveyed indicated they would likely use the new atopic dermatitis test after a brief overview [20] - The target population for the atopic dermatitis test is around 13 million patients aged 12 and older in the U.S. [10][22] Conclusion - Castle Biosciences is positioned for growth with a strong product pipeline and significant market opportunities in dermatology and gastroenterology, supported by promising clinical data and positive clinician feedback [23]

Castle Biosciences FY Conference Summary Company Overview - **Company**: Castle Biosciences (NasdaqGM:CSTL) - **Date**: November 19, 2025 - **Key Speaker**: Derek Maetzold, CEO Key Points Financial Performance - **Q3 Revenue Growth**: Normalized pro forma revenue grew by 36% year-over-year, matching the test volume growth of 36% for core TissueCypher and melanoma tests [4][5] - **Cash Position**: Ended the quarter with approximately $289 million in cash or cash equivalents, indicating a strong balance sheet [5] - **Year-End Guidance**: Raised guidance by $16 million, now projected between $327 million and $335 million [5] Product Performance - **DecisionDx-Melanoma**: Growth reaccelerated by 12% in Q3, attributed to a sales team refocus towards melanoma tests [6] - **Clinician Engagement**: 1,816 clinicians ordered DecisionDx-Melanoma tests in Q3, indicating strong market penetration [6] - **Market Penetration**: Estimated at around 30%, with ongoing efforts to drive adoption among clinicians [8] Clinical Studies and Data - **Influential Studies**: Key studies published have shown that patients who avoided sentinel lymph node biopsy based on low-risk results from DecisionDx-Melanoma had zero recurrences, supporting the test's clinical utility [11][12] - **Histological Subtyping**: Data presented at the Fall Clinical Dermatology meeting indicated that patients with low-risk results from the test had a 98.5% chance of being alive at five years [14] Regulatory and Reimbursement Insights - **FDA Breakthrough Designation**: Received earlier in the year, with plans for submission in early 2026 [16] - **Reimbursement Potential**: Anticipated improvements in coverage eligibility under state biomarker laws post-FDA approval [17][18] Market Dynamics - **Atopic Dermatitis Test Launch**: Targeting approximately 13 million patients with moderate to severe atopic dermatitis, aiming to identify JAK inhibitor responders [46][47] - **Market Research Feedback**: Positive responses from dermatologists regarding the test's ability to reduce trial and error in treatment [52] Growth Opportunities - **TissueCypher Expansion**: Plans to enhance the test with multi-omics capabilities and a non-endoscopic self-collection device [31][33] - **Sales Team Expansion**: Increased reach in the GI market, with a focus on improving touchpoints and frequency within existing areas [30] Financial Outlook - **Gross Margin Projections**: Expected to be in the mid-70% range on an adjusted basis, with potential pressure from the atopic dermatitis launch [56] - **Operating Leverage**: Anticipated growth in revenue and profitability as the company continues to expand its product offerings [58] Strategic Initiatives - **Capital Allocation**: Plans to invest in commercial activities, clinical studies, and pipeline opportunities, including collaborations with other companies [62] Misunderstood Elements - **Market Perception**: The focus on squamous cell carcinoma coverage overshadowed the healthy growth of the overall business, particularly in the TissueCypher segment [67] Conclusion Castle Biosciences is positioned for continued growth with strong financial performance, innovative product offerings, and strategic regulatory initiatives. The company is actively working to expand its market presence and improve patient outcomes through its diagnostic tests.

Core Insights - Castle Biosciences has been recognized as a Houston Top Workplace for the fifth consecutive year, highlighting its people-focused workplace culture [1][2] - The company has also received three Culture Excellence Awards in Employee Appreciation, Employee Well-Being, and Professional Development [1][7] - Castle has maintained a strong culture of excellence while more than doubling its workforce since its first Top Workplaces designation in November 2021 [2] Company Overview - Castle Biosciences is a leading diagnostics company focused on improving health through innovative tests that guide patient care, particularly in dermatologic and gastroenterological diseases [4] - The company develops personalized, clinically actionable solutions aimed at enhancing disease management and patient outcomes [4][5] Employee Feedback and Recognition - The Top Workplaces designation is based on anonymous employee feedback collected through a third-party survey, measuring aspects such as respect, support, growth opportunities, and empowerment [3] - In 2025, Castle ranked third among recognized companies in its size bracket within the Top Workplaces Healthcare Industry category [7]

Core Insights - Castle Biosciences, Inc. announced new data showcasing the clinical value of its DecisionDx-Melanoma test in enhancing sentinel lymph node biopsy decision-making and recurrence risk prediction for patients with cutaneous melanoma [1][2] Group 1: Clinical Value of DecisionDx-Melanoma - The DecisionDx-Melanoma test helps physicians make informed decisions regarding sentinel lymph node biopsy by accurately identifying patients with low likelihood of sentinel node positivity, allowing some to safely forgo the procedure [2][4] - Current guidelines suggest considering SLNB when the estimated probability of a positive node exceeds 5%, but up to 88% of SLNB procedures yield negative results, highlighting the need for better identification tools [2][4] - The test utilizes tumor biology to generate a personalized risk assessment, combining gene-expression profiling with clinicopathologic features to support patient management decisions [2][6] Group 2: Study Findings and Presentations - At the 2nd European Congress on Dermato-Oncology, two studies will be presented, demonstrating that the i31-SLNB algorithm outperforms the MIA nomogram in predicting SLN positivity [3][4] - The i31-SLNB algorithm showed an AUC of 0.74 compared to 0.61 for the MIA nomogram, indicating superior sensitivity and specificity in identifying patients at low (<5%) and high (>10%) risk of SLN positivity [4][11] - In a multicenter study of 810 patients, the DecisionDx-Melanoma test was found to be an independent predictor of recurrence, significantly improving risk prediction beyond AJCC staging alone [11]

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Company Overview - Castle Biosciences, Inc. is a diagnostics company focused on improving health through innovative tests that guide patient care [3] - The company specializes in dermatologic and gastroenterological diseases, developing personalized and clinically actionable solutions to enhance disease management and patient outcomes [3] Upcoming Presentation - The executive management of Castle Biosciences is scheduled to present a company overview at the Piper Sandler 37th Annual Healthcare Conference on December 2, 2025, at 1:10 p.m. Eastern time [1] - A live audio webcast of the presentation will be available on the company's website, with a replay accessible after the live broadcast [2] Company Mission - Castle Biosciences emphasizes a patient-first approach, empowering patients and clinicians by informing care decisions through rigorous science and advanced molecular tests [4] - The company aims to support more confident treatment planning through its innovative diagnostic solutions [4]