The research, published in npj Breast Cancer, analyzed 426 patients diagnosed with HR+/HER2- invasive breast cancer. By evaluating tumor biology through a combination of RNA expression and spatial proteomics, the AidaBREAST assay segments patients into risk categories. Those identified as elevated risk are shown to derive significant therapeutic benefit from radiation, while low-risk patients exhibit minimal recurrence rates regardless of whether they undergo such treatment.

Dr. Bruce Mann, who led the validation study, noted that the findings provide a necessary layer of insight beyond standard clinical assessments. This capability allows clinicians to move toward more individualized treatment plans. The validation arrives shortly after the test received an FDA Breakthrough Device designation, positioning it as a successor to the company’s existing DCISionRT platform. PreludeDx executives view this milestone as a core step in expanding their diagnostic suite to eventually incorporate endocrine and chemotherapy benefit assessments.