A blinded validation in more than 400 women shows the test provides clearer guidance on recurrence risk and radiation therapy decisions.
PreludeDx has announced results from an independent validation study of AidaBreast, a multi-omic biosignature test designed to predict 10-year locoregional recurrence (LLR) risk and individualized radiation therapy (RT) benefit in women with early-stage invasive breast cancer.
The validation study, conducted at Royal Melbourne Hospital in Australia, evaluated more than 400 women with early-stage HR+/HER2- invasive breast cancer who underwent breast-conserving surgery and endocrine therapy, with or without radiation therapy.
The results confirmed and strengthened PreludeDx’s initial validation:
- AidaBreast stratifies women into low risk and elevated risk groups based on underlying tumor biology.
- Within the elevated risk group, the test identifies which women are likely to experience significant therapeutic benefit from RT, and which show minimal benefit from RT, despite elevated recurrence risk.
- Women in the low risk group demonstrated very low 10-year recurrence rates whether or not they received radiation therapy.
“This independent blinded validation confirms the prior results, demonstrating that AidaBreast is prognostic for LRR risk and predictive for RT benefit,” says Dr Bruce Mann, principal investigator of the study and director of research at Breast Cancer Trials, in a release. “The results demonstrated that the test identified patients who are good candidates for the omission of RT and patients who would significantly benefit from radiation therapy.”
The findings will be presented at the San Antonio Breast Cancer Symposium 2025 by Mann, along with Troy Bremer, PhD, chief scientific officer of PreludeDx.
Multi-Omic Technology Approach
AidaBreast uses multi-omic technology by analyzing RNA and protein expression together with spatial biology. According to PreludeDx, this approach provides a more complete assessment of a patient’s tumor biology compared to existing tests.
“This is the first and only commercially available test developed specifically for RT in Stage I and LLA breast cancer,” says Bremer in a release. “Prior tests were focused on metastatic risk and chemotherapy benefit. AidaBreast incorporates both RNA and functional proteins that drive tumor biology, giving patients and clinicians the first tool for assessing both recurrence risk and predicting radiation therapy benefit.”
The test is designed specifically for Stage I and IIa breast cancer patients, addressing a gap in radiation therapy decision-making tools for this patient population.
Clinical Decision Support
PreludeDx positions AidaBreast as a clinical decision support tool that provides information not available through clinicopathology alone. The test aims to help patients and physicians make more informed treatment decisions regarding radiation therapy following breast-conserving surgery.
“AidaBreast provides a new level of clarity for women with early-stage invasive breast cancer,” says Dan Forche, president and CEO of PreludeDx, in a release. “For the first time, patients and physicians have a tool for Stage I and IIa breast cancer that supports shared treatment decisions, helping women make more confident and informed choices on radiation therapy.”
Future development plans for AidaBreast include evaluation of endocrine therapy and chemotherapy benefit, with the goal of creating a unified decision-support tool for early-stage invasive breast cancer treatment.
Building on Existing Portfolio
AidaBreast builds on PreludeDx’s existing DCISionRT test, which is used for radiation therapy decision-making in women diagnosed with ductal carcinoma in situ (DCIS). DCISionRT combines protein expression from seven biomarkers and four clinicopathologic factors using a non-linear algorithm.
PreludeDx was founded in 2009 with technology licensed from the University of California San Francisco and focuses on developing precision breast cancer diagnostic tools.
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