Validated Test Predicts Recurrence Risk and Radiation Benefit in Early-Stage Breast Cancer

Standard clinicopathologic features can inform these decisions but may not fully capture the tumor biology that influences recurrence and treatment response. A newly validated multi-omic test now assesses recurrence risk while also predicting potential benefit from radiation therapy.

PreludeDx’s (Laguna Hills, CA, USA) AidaBREAST is a clinical risk assessment test designed for patients with stage I and IIa breast cancer to estimate recurrence risk and predict potential benefit from radiation therapy. The next-generation multi-omic assay uses advanced spatial biology technology to combine multiplex protein expression with targeted next-generation RNA sequencing. 

Using artificial intelligence, AidaBREAST integrates these molecular data to generate an individualized 10-year risk of locoregional recurrence and assess the expected benefit of radiation therapy. The test recently received U.S. Food and Drug Administration (FDA) Breakthrough Device designation (BDD).

The independent, blinded validation study was published on September 24, 2026, in npj Breast Cancer. Conducted at Royal Melbourne Hospital in Australia, the study evaluated 426 women with early-stage HR-positive, HER2-negative invasive breast cancer. All patients underwent breast-conserving surgery and were prescribed endocrine therapy, with or without radiation therapy. The publication represents the initial validation of AidaBREAST.

AidaBREAST stratifies women into Low Risk and Elevated Risk groups based on underlying tumor biology. Within the Elevated Risk group, the test further identifies women who are more likely to derive significant therapeutic benefit from radiation therapy. Women classified as Low Risk showed low 10-year recurrence rates regardless of whether they received radiation therapy. Future development is expected to expand the platform to evaluate potential benefit from endocrine therapy and chemotherapy as part of a unified decision-support tool.

“This independent blinded validation provides important confirmation of AidaBREAST's ability to assess locoregional recurrence risk and radiation therapy benefit in early-stage invasive breast cancer. The findings reinforce that tumor biology can provide information beyond standard clinicopathologic features alone, helping physicians and patients have more individualized conversations about radiation therapy,” said Dr. Bruce Mann, Head of Breast Surgical Research at Royal Melbourne Hospital, and Principal Investigator of the study. 

Related Links
PreludeDx