AidaBREAST Gains FDA Breakthrough Status for Personalized Radiotherapy in Early Breast Cancer

Prelude Corporation, also known as PreludeDx, announced that the U.S. Food and Drug Administration has granted Breakthrough Device designation to AidaBREAST®, its early-stage invasive breast cancer assay. The designation marks an important regulatory step for a test intended to support more individualized treatment decisions 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.”

AidaBREAST is designed for women with stage I or IIa invasive breast cancer. The assay provides two clinically relevant outputs: an individualized prognostic assessment of 10-year locoregional recurrence risk and a prediction of the expected benefit from adjuvant radiation therapy. In clinical practice, this type of information could help physicians and patients weigh the potential value of radiation therapy more precisely, particularly in cases where conventional clinicopathologic factors may not fully capture tumor biology.

The company says AidaBREAST uses a next-generation multi-omic platform that combines multiplex protein expression with targeted next-generation RNA sequencing. The assay applies spatial biology technologies and artificial intelligence to integrate these molecular and tumor biology signals into a patient-specific risk assessment. According to PreludeDx, this approach is intended to move beyond traditional measures used in early breast cancer risk evaluation.

The test has a dual function: it is not only prognostic for recurrence risk but also predictive of radiation therapy benefit. This distinction is important because many risk tools estimate the likelihood of recurrence, but fewer are designed to identify which patients are most likely to gain meaningful benefit from a specific adjuvant intervention.

Forche added, “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 for patients with early-stage breast cancer.”

AidaBREAST test support de-escalation in patients with low predicted radiation benefit, while helping identify patients for whom radiation remains clinically important despite apparently favorable disease features. PreludeDx positions the assay as a tool to help avoid both overtreatment and undertreatment in early-stage invasive breast cancer.