PreludeDx Reports Independent Validation of AidaBREAST Test

Laguna Hills, California, U.S., October 8, 2026

Independent Study Validates AidaBREAST’s Clinical Potential

The independent, blinded validation study was conducted at Royal Melbourne Hospital in Australia and evaluated 426 women with early-stage hormone receptor-positive, human epidermal growth factor receptor 2-negative (HR+/HER2−) invasive breast cancer. The participants underwent breast-conserving surgery and received prescribed endocrine therapy, with or without radiation therapy. The study independently evaluated AidaBREAST’s ability to assess 10-year locoregional recurrence risk and predict the potential benefit of adjuvant radiation therapy. According to PreludeDx, the publication confirms the company’s initial validation findings and supports the use of tumor biology to provide additional information beyond conventional clinicopathological characteristics. These findings may help physicians and patients have more individualized discussions about post-surgical treatment options. Dr. Bruce Mann, Head of Breast Surgical Research at Royal Melbourne Hospital and the study’s principal investigator, highlighted the importance of the independent validation. He noted that the findings reinforce the potential value of biological information in assessing recurrence risk and radiation therapy benefit, supporting more personalized treatment discussions for women with early-stage invasive breast cancer. AidaBREAST is designed to stratify patients into Low Risk and Elevated Risk groups according to their underlying tumor biology. The company reported that women in the Low Risk group demonstrated low 10-year recurrence rates regardless of whether they received radiation therapy. Among women classified as Elevated Risk, the test is designed to identify those more likely to experience a significant therapeutic benefit from radiation treatment.

Multi-Omic Technology Supports Personalized Treatment Decisions

AidaBREAST combines spatial proteomic analysis and RNA expression profiling to generate an individualized assessment of breast cancer biology. The next-generation assay integrates multiplex protein expression with targeted next-generation RNA sequencing, capturing different biological characteristics of a patient’s tumor. The company also uses artificial intelligence to integrate these complex data and generate an assessment of recurrence risk and predicted radiation therapy benefit. PreludeDx describes AidaBREAST as the first and only clinical test in its intended stage I and IIA breast cancer setting to provide both prognostic information and predictive insight into radiation therapy benefit. Its approach is intended to complement traditional clinical and pathological assessments rather than rely exclusively on conventional tumor characteristics. Dan Forche, President and Chief Executive Officer of PreludeDx, said publication of the independent validation study represents an important milestone for AidaBREAST, particularly following its recent FDA Breakthrough Device designation. The company aims to advance biology-driven decision-support tools that help women and their physicians make more informed treatment decisions. Troy Bremer, Ph.D., Chief Scientific Officer of PreludeDx, emphasized that integrating RNA expression and spatial proteomic expression enables the company to capture multiple dimensions of tumor biology. The approach forms the foundation of AidaBREAST’s individualized assessment of recurrence risk and radiation therapy benefit.

PreludeDx Expands Its Breast Cancer Diagnostics Portfolio

AidaBREAST builds on PreludeDx’s experience with DCISionRT®, its diagnostic test designed to support radiation therapy decision-making for women diagnosed with ductal carcinoma in situ (DCIS). According to the company, AidaBREAST represents its second FDA Breakthrough Device designation and extends its precision diagnostics strategy into early-stage invasive breast cancer. PreludeDx also plans to evaluate the potential application of its approach to assessing endocrine therapy and chemotherapy benefit. These future evaluations could support the development of a more integrated decision-support tool for early-stage breast cancer care. However, these applications remain future plans and should not be interpreted as established capabilities of the current test. The independent publication strengthens the evidence base for AidaBREAST’s intended role in personalized breast cancer care. Further clinical evaluation and appropriate regulatory considerations will remain important in determining how the test can support treatment decisions across patient populations.

Source: PreludeDx press release