FDA Breakthrough Status Awarded to PreludeDx for AidaBREAST Test in Early Breast Cancer

Prelude Corporation (PreludeDx) has received FDA Breakthrough Device designation for its AidaBREAST® assay, a multi-omic test designed to guide treatment decisions in early-stage invasive breast cancer. The designation marks the company’s second, following its earlier recognition for DCISionRT®.AidaBREAST is intended for women with stage I–IIa invasive breast cancer and provides a personalized assessment of 10-year locoregional recurrence risk, while also predicting which patients are most likely to benefit from adjuvant radiation therapy after 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.”

The assay integrates multiplex protein expression with targeted RNA sequencing and artificial intelligence to analyze tumor biology, aiming to reduce both over- and undertreatment. According to the company, AidaBREAST is the only test in this population that predicts radiation therapy benefit alongside recurrence risk.
The FDA’s Breakthrough Device program is reserved for technologies that may offer significant advantages over existing options and provides priority review to accelerate patient access.

“We look forward to working closely with the FDA as we advance AidaBREAST through the regulatory process and remain committed to expanding access to precision diagnostic tools that improve outcomes,” Forche added.