Customer Service: 866-788-9007

Customer Service: 866-788-9007

Customer Service: 866-788-9007

Our Approach

A Focus On Dermatologic Cancers

Our approach to product development starts by identifying cancers for which genomic information could significantly improve disease staging and/or patient management decisions. We look for opportunities where current staging does not sufficiently identify patient risk or where it would be clinically useful to understand the likely response of a tumor to standard of care. We dig deep into skin cancer clinical treatment pathways to find areas of unmet medical need where we can leverage our expertise in cancer genomics and data analytics to improve – and potentially transform – patient outcomes. Operating under CAP-accredited, CLIA-certified laboratory conditions, we focus on developing clinically impactful diagnostic, prognostic and predictive tests discovered in-house or licensed from recognized research institutions.

Pioneering Developments in Molecular Diagnostics

Our research and development efforts use state-of-the-art technology and bioinformatics working collaboratively with our scientists to build proprietary algorithms based on machine-learning techniques with artificial intelligence. The goal is to identify critical molecular characteristics that provide important diagnostic information about an individual patient’s tumor. We then partner with academic researchers to complete multi-center clinical studies that are optimally designed to validate a test’s accuracy and pave the way for broad adoption and reimbursement. Following clinical validation, we rapidly institute clinical utility studies to document and ensure appropriate use.

DecisionDx®-Melanoma meets the need for more accurate diagnostic & prognostic tools

To address the clinical need for more accurate assessment of metastatic risk in cutaneous melanoma, Castle Biosciences’ R&D team worked with academic centers around the country to develop and validate DecisionDx-Melanoma, a prognostic gene expression profile test that utilizes tumor biology to provide an individual risk of recurrence or metastasis for patients with melanoma. The performance of the test has been evaluated in several prospective and retrospective multi-center studies that have consistently demonstrated the accuracy and independence of the test compared to current clinical staging characteristics.

Predicting Individual Risk of Recurrence in Early Stage Melanoma

Nearly all treatment plan decisions made around the time of diagnosis of cutaneous melanoma rely upon the risk of recurrence. These decisions include whether to perform the invasive sentinel lymph node (SLN) biopsy surgical procedure to see whether cancer cells are found in lymph nodes, as well deciding what level of follow-up, imaging and referrals are appropriate. In the past, risk of recurrence was estimated from traditional clinical and pathologic prognostic factors. Our DecisionDx-Melanoma test assesses the risk of recurrence based on the biology of the primary tumor, enabling these treatment decisions to be made in the context of both traditional prognostic factors and the biology of an individual patient’s tumor.

DecisionDx®-SCC is now launched for high-risk cutaneous squamous cell carcinoma

Castle Biosciences’ newest test is now available, addressing clinical unmet need for patients with cutaneous squamous cell carcinoma (SCC) and one or more risk factors. DecisionDx-SCC is a prognostic, gene expression profile test that utilizes tumor biology to provide an individual risk of metastasis for patients with high-risk SCC. Validation study results indicate DecisionDx-SCC is the strongest independent predictor of metastasis and complementary to traditional risk assessment systems, which are based on clinical and pathologic factors.

Castle Biosciences also offers the DecisionDx®-UM test that stratifies low and high risk uveal melanoma tumors, and has active research programs addressing other underserved cancers.

“Our product development starts by identifying a disease where molecular information could vastly improve patient management decisions.”

Federico Monzon, M.D., FCAP
Chief Medical Officer