Castle Biosciences, a skin cancer diagnostics company providing personalized genomic information to improve cancer treatment decisions, today announced that DecisionDx-SCC, its prognostic gene expression profile test for patients diagnosed with high-risk cutaneous squamous cell carcinoma (SCC), is now commercially available.

“We are pleased to offer DecisionDx-SCC, intended for use in adding actionable, patient-specific information to risk assessment and to help guide management decisions in SCC,” said Derek Maetzold, president and chief executive officer of Castle. “Using current SCC staging methods, about 200,000 patients annually are classified as high risk based on various clinical and pathological factors. But this relatively broad high-risk category leaves room for over- and undertreatment—a degree of uncertainty that patients and clinicians cannot afford, as death rates from SCC continue to rise. Now with the ability to add DecisionDx-SCC to commonly used clinical and pathological factors, we believe that this important innovation will improve prognostic accuracy and risk-appropriate management planning. We expect to see strong demand for DecisionDx-SCC, as we build upon our success with DecisionDx-UM and DecisionDx-Melanoma and follow our established model for commercialization.”

Ashley Wysong, M.D., University of Nebraska Medical Center, Omaha NE stated, “As SCC cancer treatment plans and their outcomes are guided by risk of metastasis, improved prognostic accuracy has direct implications on patient management. By classifying SCC patients with existing risk factors into low, moderate and high biological risk categories, we believe DecisionDx-SCC can contribute positive predictive value to follow-up and management recommendations, potentially changing or narrowing recommendations in line with individual risk. I look forward to integrating tumor biology through DecisionDx-SCC into the clinical care of my patients.”

The DecisionDx-SCC test is a qRT-PCR assay of 40 genes that uses a neural network algorithm to classify patients into risk categories. Independent validation was performed in a prospectively designed, multi-center (33 sites) study using archival tissue from 420 patients with known 3-year outcomes. The test’s validity and impact are supported by four peer-reviewed articles publications.

Source: Company Press Release