DecisionDx-SCC is a 40-gene expression profile test that uses an individual patient’s tumor biology to predict individual risk of metastasis in patients with SCC with one or more risk factors.

Castle Biosciences, Inc’s DecisionDx-SCC can provide significant and independent prognostic value for stratifying metastasis risk in patients with cutaneous squamous cell carcinoma (SCC) with one or more risk factors (high risk), a new study shows.

The study appears in Future Oncology.

“As the criteria for high-risk SCC is broad, it can be challenging for clinicians to appropriately manage a patient’s disease using only their clinicopathologic risk factors,” says the study’s first author, Sherrif Ibrahim, M.D., Ph.D., dermatologist and Mohs surgeon at Rochester Dermatologic Surgery, Victor, New York, and associate professor, Department of Dermatology at University of Rochester Medical Center, Rochester, New York, in a news release. “DecisionDx-SCC is designed to provide powerful prognostic information regarding a patient’s risk of metastasis, based on the biology of the individual patient’s tumor. As a physician, I rely on this information to help me make informed and personalized decisions in the management and follow-up care of patients with SCC.”

DecisionDx-SCC is a 40-gene expression profile test that uses an individual patient’s tumor biology to predict individual risk of metastasis in patients with SCC with one or more risk factors. The test result, in which patients are stratified into a Class 1 (low), 2A (moderate) or 2B (high) risk category, predicts individual metastatic risk to inform risk-appropriate management decisions.

In the retrospective cohort of 420 cases of primary SCC tumors with known patient outcomes who underwent testing with DecisionDx-SCC, DecisionDx-SCC enhanced clinicopathologic risk factor-based assessment and identified a group of SCC patients within a high-risk cohort with metastasis rates similar to the general SCC population (Class 1 result with one risk factor).

Patients identified by DecisionDx-SCC as having the highest risk for metastasis (Class 2B) consistently had metastasis rates ≥50%, regardless of having one or two or more risk factors. Combining DecisionDx-SCC with clinicopathologic factor-based risk assessment, regardless of whether it is based on risk factor count or T stage, further stratified risk for metastasis in SCC patients and improved the accuracy of risk predictions to better inform risk-appropriate patient management decisions, the study showed.