Castle Biosciences, Inc. develops and commercializes molecular diagnostic tests used to guide care in dermatologic and gastroenterological disease. Its recurring updates focus on test report volume, revenue performance, guidance, and clinical evidence for products such as DecisionDx-Melanoma and TissueCypher.
Company news also covers studies, publications, and medical-meeting presentations involving risk stratification for cutaneous melanoma, sentinel lymph node biopsy decision support through DecisionDx-Melanoma’s i31-SLNB result, and Barrett’s esophagus progression-risk assessment with TissueCypher. Financial releases frequently discuss core revenue drivers, reimbursement effects, commercial focus, and quarterly operating results.
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Castle Biosciences, Inc. (Nasdaq: CSTL) will present at the Canaccord Genuity Virtual MedTech, Diagnostics and Digital Health & Services Forum on Thursday, Nov. 18, 2021, at 9:30 a.m. Eastern time. CEO Derek Maetzold and CFO Frank Stokes will share insights about the company’s innovative diagnostics aimed at improving patient outcomes. Live audio webcasts will be available on the company’s website, with replays accessible for two weeks post-event. Castle specializes in personalized genomic information for better treatment decisions in cancers like melanoma.
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.
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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.