A Focus on Underserved Cancers

Our tests provide actionable, tumor-specific information to improve care

Our approach to product development starts by identifying underserved 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. 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.

Our research and development efforts use state-of-the-art technology and bioinformatics to identify critical molecular characteristics that provide important diagnostic information about an individual patient’s tumor. Our research team then partners 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 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 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.

The ability to accurately identify recurrence risk for patients with early stage melanoma is clinically important because follow-up plans should be individualized and based on risk of recurrence. Accurate identification and appropriate surveillance of high-risk patients is especially critical. Recent studies have shown that earlier detection of metastasis, with lower tumor burden, is associated with better response to contemporary therapies. For low-risk patients the test result can provide reassurance to those who may receive lower intensity follow up.

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.