Multi-Omic Assay Predicts Recurrence and Radiation Benefit in Early Breast Cancer

Early-stage invasive breast cancer is frequently managed with breast-conserving surgery followed by adjuvant radiation therapy, but the magnitude of benefit from radiation varies among patients. Clinicians need decision-support tools that quantify locoregional recurrence risk and clarify which patients are most likely to benefit from radiation. Multi-omic, tumor-informed assays are emerging to address this gap by integrating signals beyond standard clinicopathologic features. A new multi-omic assay now provides individualized 10-year locoregional recurrence risk and predicted benefit from adjuvant radiation after breast-conserving surgery.

PreludeDx’s (Laguna Hills, CA, USA) AidaBREAST test has received U.S. Food and Drug Administration (FDA) Breakthrough Device designation, marking the company’s second Breakthrough Device following DCISionRT. The assay is intended for women with early-stage (I, IIa) invasive breast cancer. It is positioned as the only risk assessment test for stage I–IIa patients that predicts radiation therapy benefit while also providing prognostic information for 10-year locoregional recurrence.

Image: The AidaBREAST assay integrates multimodal data to provide patient-specific 10-year recurrence risk and individualized predictions of radiation therapy benefit (photo courtesy of PreludeDx)

AidaBREAST is a next-generation multi-omic assay built on advanced spatial biology methods. It combines multiplex protein expression with targeted next-generation RNA sequencing to generate a comprehensive view of tumor biology. The platform integrates these multimodal data to deliver a patient-specific risk estimate for 10-year locoregional recurrence and an individualized prediction of radiation therapy benefit, supporting more tailored post-surgical treatment planning.

For the intended use population, the assay is designed to inform decisions following breast-conserving surgery by identifying those most and least likely to benefit from adjuvant radiation. In addition to predicting benefit, the test aims to aid in preventing both over- and undertreatment of early-stage disease. The framework is positioned to help physicians move beyond traditional measures with patient-specific results.

The FDA’s Breakthrough Device designation is reserved for technologies that may offer more effective diagnosis or treatment and significant advantages over cleared or approved alternatives. Designated devices receive priority review, which can accelerate interactions with the agency during the regulatory process. The AidaBREAST designation underscores ongoing development of precision tools for individualized radiation decision-making in early-stage invasive breast cancer.

“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. 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,” said Dan Forche, President and CEO of PreludeDx.

“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,” added Forche.

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