DCISionRT Test Receives FDA Breakthrough Device Designation

Prelude Corporation (PreludeDx) announced that US 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.

"DCISionRT addresses an unmet need for DCIS patients by answering the questions, 'Do I need radiation therapy?', and 'will I benefit?'. DCISionRT helps patients and their physicians to make a better and more informed treatment decision," says Dan Forche, President and CEO of PreludeDx.

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.

Forche continued, "We will continue to work closely with the FDA and we remain committed to providing access to advanced precision diagnostics in breast cancer care that improve patient outcomes through new and innovative tools."