An independent validation study of 426 patients evaluated the assay’s ability to assess 10-year recurrence risk and identify patients more likely to benefit from radiation therapy.
Results from the first independent validation of the AidaBREAST test have been published in npj Breast Cancer, validating the multi-omic biosignature’s ability to assess 10-year locoregional recurrence risk and predict individual benefit from adjuvant radiation therapy in early-stage breast cancer.
The independent, blinded study was conducted at Royal Melbourne Hospital in Australia. Researchers evaluated 426 women with early-stage HR+/HER2- invasive breast cancer who underwent breast-conserving surgery and received endocrine therapy, with or without radiation therapy. The findings confirm initial validation results for the test, which is intended for patients with stage I and IIa breast cancer.
“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,” says Bruce Mann, PhD, head of breast surgical research at Royal Melbourne Hospital and principal investigator of the study, in a release. “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.”
Spatial Biology and Multi-Omic Analysis
Developed by PreludeDx, AidaBREAST combines multiplex protein expression using spatial biology techniques with targeted next-generation RNA sequencing. The assay uses artificial intelligence algorithms to integrate spatial proteomic and genomic data, calculating an individualized assessment of recurrence risk alongside the likelihood of benefit from radiation therapy following breast-conserving surgery.
“This study further supports the strength of our multi-omic approach,” says Troy Bremer, PhD, chief scientific officer of PreludeDx, in a release. “By integrating RNA expression and spatial proteomic expression, AidaBREAST is designed to capture multiple dimensions of tumor biology.”
Expanding Clinical Decision Support
The publication follows a recent FDA Breakthrough Device designation granted to AidaBREAST. The assay represents PreludeDx’s second platform to earn the designation, following the company’s DCISionRT test, which assesses radiation therapy benefit for patients diagnosed with ductal carcinoma in situ.
“The publication of this independent validation study in npj Breast Cancer marks another important milestone for AidaBREAST, following its recent FDA Breakthrough Device designation,” says Dan Forche, president and CEO of PreludeDx, in a release. “Together, these milestones reflect our mission to advance personalized, biology-driven decision support for women with early-stage invasive breast cancer and the physicians who care for them.”
According to the company, evaluating radiation therapy benefit is the initial phase of its testing strategy for early-stage invasive disease. PreludeDx plans to expand the assay to evaluate endocrine therapy and chemotherapy benefit to create an integrated decision-support tool.
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