PreludeDx Genomic Breast Cancer Test Surpasses 45,000 Patient Milestone

More than 3,000 physicians across the United States have now utilized DCISionRT to guide treatment for over 45,000 patients diagnosed with ductal carcinoma in situ. This milestone underscores a shift toward molecular-based risk assessment in breast cancer care, moving away from traditional clinical-pathologic criteria for post-surgery radiotherapy.

Since its 2017 launch, the diagnostic tool has seen rapid integration into standard treatment planning. Currently, one in three women undergoing breast-conserving surgery in the U.S. receives the test to determine if radiation therapy is medically necessary. The adoption reflects a broader clinical push to reduce both overtreatment and undertreatment by analyzing the specific molecular biology of individual tumors.

Clinical evidence supporting the test remains robust, most notably through the multicenter PREDICT study. Among 2,007 patients analyzed, the diagnostic results prompted clinicians to alter radiation therapy recommendations in 38% of cases. Dr. Atif Khan of Memorial Sloan Kettering Cancer Center noted that the test frequently reclassifies patients, citing instances where over 50% of those initially categorized as low-risk by standard criteria were identified as high-risk through molecular profiling. These findings have earned the platform both FDA Breakthrough Device designation and CMS Advanced Diagnostic Laboratory Test status, solidifying its role in routine oncology workflows.