Welcome to our dedicated page for Castle Biosciences news (Ticker: CSTL), a resource for investors and traders seeking the latest updates and insights on Castle Biosciences stock.
Castle Biosciences Inc (NASDAQ: CSTL) develops molecular diagnostic tests that guide cancer treatment decisions through gene expression profiling. The company's news flow centers on clinical validation studies, regulatory milestones, and commercial adoption of its diagnostic products.
Key news categories for Castle Biosciences include FDA regulatory developments such as breakthrough device designations, new test launches expanding the company's diagnostic portfolio, and peer-reviewed clinical study publications demonstrating test performance. The company regularly reports ordering volume milestones that indicate market adoption, as well as payer coverage decisions that affect reimbursement.
Quarterly earnings announcements provide insight into test volume growth across the DecisionDx-Melanoma, DecisionDx-UM, and TissueCypher product lines. Partnership and licensing agreements signal strategic expansion into new diagnostic areas. Scientific conference presentations at dermatology, oncology, and gastroenterology meetings often precede published research findings.
Follow Castle Biosciences news to track developments in precision oncology diagnostics, including clinical evidence supporting gene expression testing in melanoma and Barrett's esophagus, regulatory pathways for diagnostic devices, and the commercial trajectory of molecular testing adoption in cancer care.
Castle Biosciences, Inc. (CSTL) reported a 54% revenue increase in Q3 2021, totaling $23.5 million compared to Q3 2020. The company is on track to meet its 2021 revenue guidance of $89-93 million. Despite a 16% decline in melanoma diagnoses versus pre-COVID levels, test report volume rose to 7,352. Gross margins were 77.9%, with adjusted gross margins at 80.9%. Cash reserves stand at $363 million. Strategic acquisitions, including Cernostics, are expected to broaden market reach and support future growth.
Castle Biosciences (CSTL) released a study validating the i31-GEP SLNB algorithm, which integrates the DecisionDx®-Melanoma gene expression profile with clinicopathologic features to improve predictions of sentinel lymph node biopsy (SLNB) positivity in melanoma patients. The algorithm demonstrated a high correlation (0.999) between predicted and observed SLN positivity rates, with a sensitivity of 95.1%. This advancement may help clinicians identify patients who can safely avoid SLNB, thus optimizing treatment strategies and potentially reducing unnecessary procedures.
Castle Biosciences, Inc. (CSTL) has partnered with ModMed to create an interface for their dermatologic electronic health record system, EMA®. This integration allows dermatologic clinicians to order Castle's skin cancer tests directly from patient records, streamlining their workflow. The DecisionDx® suite of tests, which provides actionable information for melanoma and skin cancer management, will be accessible within EMA. This initiative aims to improve patient care and is expected to be operational by the end of 2021.
Castle Biosciences (NASDAQ: CSTL) has enhanced its DecisionDx-Melanoma test by integrating the new i31-GEP for Risk of Recurrence (i31-ROR) algorithm. This innovation aims to predict five-year outcomes for melanoma-specific survival, distant metastasis-free survival, and recurrence-free survival, improving treatment precision for patients. The company previously launched i31-SLNB to provide risk assessments for sentinel lymph node positivity. Both algorithms utilize tumor-specific data, with validation from over 5,700 samples, promising better patient management and treatment pathways.
Castle Biosciences (Nasdaq: CSTL) has announced new data validating its DecisionDx® DiffDx™-Melanoma test as an accurate tool for diagnosing challenging melanocytic lesions. Highlighted at the ASDP Annual Meeting (Oct. 20-24), the study demonstrated a high 96% sensitivity and 92.2% specificity, showcasing the test's reliability. When combined with myPath® Melanoma, the diagnostic workflow increased actionable results from 78% to 99%. This advancement enhances diagnostic confidence, improving patient care in uncertain cases.
Pittsburgh Life Science Greenhouse announced that Castle Biosciences (CSTL) will acquire Cernostics, a company focused on spatial biology and AI-driven tissue biopsy analysis. The acquisition involves an initial payment of $30 million, with additional potential payments of up to $50 million based on performance metrics in 2022. Cernostics is known for its TissueCypher® Barrett's Esophagus Assay, which predicts the risk of high-grade dysplasia and esophageal cancer in Barrett's esophagus patients. The deal is expected to close by year-end 2021.
Castle Biosciences, Inc. (NASDAQ: CSTL) is set to release its financial results for the third quarter and nine months ended Sept. 30, 2021, after market close on Nov. 8, 2021. Management will hold a conference call and webcast at 4:30 p.m. Eastern time to discuss these results. The company focuses on innovative diagnostics aimed at improving disease management and patient outcomes, particularly in skin cancer diagnostics.
Castle Biosciences (Nasdaq: CSTL) has announced recent presentations at the 2021 Fall Clinical Dermatology Conference, showcasing advancements in dermatologic cancer gene expression profile (GEP) tests and a pipeline initiative for inflammatory skin conditions. The company demonstrated the capabilities of its DecisionDx-Melanoma test, which provides personalized risk predictions for melanoma patients. Additionally, Castle is developing a GEP test to guide therapy selection for moderate to severe psoriasis and atopic dermatitis, addressing a significant unmet clinical need.
Castle Biosciences, Inc. (CSTL) has announced the acquisition of Cernostics, Inc., enhancing its growth strategy with the TissueCypher® platform aimed at improving the diagnosis of esophageal cancer. This acquisition is expected to expand Castle's U.S. total addressable market by approximately $1 billion. The deal includes an initial payment of $30 million, with potential milestone payments of up to $50 million based on 2022 performance. The acquisition aligns with Castle's mission to utilize innovative technology for better patient outcomes in gastrointestinal diagnostics.
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