Prelude Corporation (PreludeDx®), a leader in precision diagnostics for early-stage breast cancer, announced today that the U.S. Food and Drug Administration (FDA) granted Breakthrough Device designation for its DCISionRT® test.
DCISionRT provides individualized risk assessment and predicts the benefit of radiation therapy (RT) for women diagnosed with ductal carcinoma in situ (DCIS), also known as Stage 0 breast cancer. DCISionRT represents a significant advancement in DCIS patient care by combining tumor biology with clinicopathologic factors to deliver personalized results.
The test analyzes seven protein biomarkers and four clinical factors to generate a Decision Score that helps physicians identify which patients are most likely to benefit from RT and can help reduce over- and under-treatment.
The test is designed for women aged 30-85 with DCIS and:
Predicts the benefit of radiation therapy after breast conserving surgery (BCS)
Is Prognostic for 10-year risk of breast cancer recurrence
Identifies patients with residual risk even after BCS and radiation therapy
The FDA’s Breakthrough Device designation is reserved for medical devices that provide for more effective treatment or diagnosis, and offer significant advantages over existing approved or cleared alternatives. Breakthrough Devices will receive priority review by the FDA, which can significantly shorten the time it takes to get approval.
