PreludeDx Receives FDA Breakthrough Device Designation for AidaBREAST® – Early-Stage Invasive Breast Cancer Assay

LAGUNA HILLS, Calif., April 29, 2026 /PRNewswire/ -- Prelude Corporation (PreludeDx™), a leader in precision diagnostics for early-stage breast cancer, announced today that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Device designation for the AidaBREAST® test.

AidaBREAST provides individualized prognostic risk assessment and predicts the benefit of radiation therapy (RT) for women diagnosed with early-stage invasive breast cancer. The test integrates multi-omic data to generate a patient-specific assessment of 10-year locoregional recurrence risk and benefit from adjuvant radiation therapy, supporting more personalized treatment decisions following breast-conserving surgery.

“AidaBREAST addresses an important need in early-stage invasive breast cancer by providing both recurrence risk assessment and insight into which patients are most likely to benefit from radiation therapy,” said Dan Forche, President and CEO of PreludeDx. “With Breakthrough Device designations for both DCISionRT and AidaBREAST, we are continuing to advance precision diagnostics that support more informed treatment decisions for patients and physicians.”

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