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As of February 19, 2026, there were 29,731,198 shares of common stock, $0.001 par value per share, outstanding.
) and foreign countries; the performance of our third-party suppliers; the success of competing diagnostic products that are or become available; our ability to attract and retain key personnel; and our expectations regarding our ability to obtain and maintain intellectual property protection for our products and our ability to operate our business without infringing on the intellectual property rights of others.
Overview Castle Biosciences is a molecular diagnostics company offering innovative test solutions to aid clinicians in the diagnosis and treatment of dermatologic cancers, Barrett s esophagus ( BE ), atopic dermatitis ( AD ), uveal melanoma ( UM ).
For our core tissue-based tests, we use multi-analyte assays with algorithmic analysis ( MAAA ) to characterize an individual patient s biology and generate clinically actionable information.
Depending on the specific test, this information may be used to provide information to help guide treatment and patient management decisions including potential responsiveness to therapy and to assist in the diagnosis of a disease.
Test Portfolio and Market Overview Our portfolio consists of test offerings to aid clinicians in the diagnosis and treatment of cancers or precancerous diagnoses in the fields of dermatology, gastroenterology and ophthalmology, and most recently includes a test to guide systemic treatment decisions in patients with moderate-to-severe AD.
The following table summarizes our commercially available tests: Dermatology Gastroenterology Ophthalmology DecisionDx-Melanoma TissueCypher DecisionDx-UM AdvanceAD-Tx (1) DecisionDx-SCC MyPath Melanoma (1) We commenced a limited launch of our AdvanceAD-Tx TM test in November 2025.
DecisionDx-Melanoma DecisionDx-Melanoma is our proprietary risk stratification gene expression profile ( GEP ) test designed to predict the likelihood of a positive sentinel lymph node and the risk of metastasis or recurrence for patients diagnosed with invasive cutaneous melanoma ( CM ), a deadly skin cancer.
Surveillance, Epidemiology, and End Results registries and subsequently adjusted for the documented underreporting of melanoma diagnoses, which ranges from 30%-72%.
As of December 31, 2025, 58 peer-reviewed articles, five of which were published in 2025, support the clinical validity, clinical utility and impact on outcomes of our DecisionDx-Melanoma test.
REMOVED
As of February 20, 2025, there were 28,514,109 shares of common stock, $0.001 par value per share, outstanding.
We are an early, commercial-stage company and have a limited operating history, which may make it difficult to evaluate our current business and predict our future performance.
Overview Castle Biosciences is a molecular diagnostics company offering innovative test solutions to aid clinicians in the diagnosis and treatment of dermatologic cancers, Barrett s esophagus, uveal melanoma, and in the treatment of mental health conditions.
For our tissue based tests, we use multi-analyte assays with algorithmic analysis ( MAAA ) to characterize an individual patient s biology to inform specific risk of progression.
Test Portfolio and Market Overview Our portfolio consists of test offerings to aid clinicians in the diagnosis and treatment of cancers or precancerous diagnoses in the fields of dermatology, gastroenterology and ophthalmology and a pharmacogenomic ( PGx ) test to guide optimal drug treatment for patients diagnosed with depression, anxiety and other mental health conditions.
DecisionDx-Melanoma DecisionDx-Melanoma is our proprietary risk stratification gene expression profile ( GEP ) test that predicts (i) the likelihood of positive sentinel lymph node and (ii) the risk of metastasis, or recurrence, for patients diagnosed with invasive cutaneous melanoma ( CM ), a deadly skin cancer.
Surveillance, Epidemiology, and End Results registries and subsequently adjusted for the documented underreporting of melanoma diagnoses which range from 30%-72%.
Based on currently available data, we estimate the targetable clinician base treating melanoma is between 11,000 and 15,000.
As of December 31, 2024, 53 peer-reviewed articles, one of which was published in 2024, support the clinical validity, clinical utility and impact on outcomes of our DecisionDx-Melanoma test.
Based on our published data, we have shown that DecisionDx-Melanoma can be an accurate, independent predictor of the risk of metastasis or recurrence, including recurrence to the sentinel lymph node.