PreludeDx Announces the Publication of the Independent Validation of the AidaBREAST® test in npj Breast Cancer

Publication follows recent FDA Breakthrough Device designation for AidaBREAST and further supports PreludeDx's leadership in personalized radiation therapy decision-making

LAGUNA HILLS, Calif., Oct. 8, 2026 /PRNewswire/ -- Prelude Corporation (PreludeDx®), a leader in precision diagnostics for early-stage breast cancer, today announced the publication of results from the first independent validation of AidaBREAST®, a novel multi-omic biosignature developed to predict a woman's 10-year risk of locoregional recurrence and her individualized benefit from adjuvant radiation therapy following breast-conserving surgery.

The independent blinded validation study, published in npj Breast Cancer, a Nature Portfolio journal, was conducted at Royal Melbourne Hospital in Australia and evaluated 426 women with early-stage HR+/HER2- invasive breast cancer who were treated with breast-conserving surgery and prescribed endocrine therapy, with or without radiation therapy. The publication confirms PreludeDx's initial validation of AidaBREAST.

"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," said Dr. Bruce Mann, Head of Breast Surgical Research at Royal Melbourne Hospital, and Principal Investigator of the study. "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."

AidaBREAST: The First and Only Clinical Test Providing Both Prognosis and Predictive Insight for Radiation Therapy in Stage I, IIa breast cancer.

"The publication of this independent validation study in npj Breast Cancer marks another important milestone for AidaBREAST, following its recent FDA Breakthrough Device designation," said Dan Forche, President and CEO of PreludeDx. "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."

AidaBREAST assessment of radiation therapy benefit is the first in a comprehensive approach for early-stage invasive breast cancer. Future plans include evaluation of endocrine therapy and chemotherapy benefit, enabling a unified, integrated decision-support tool.

"This study further supports the strength of our multi-omic approach," said Troy Bremer, PhD, Chief Scientific Officer of PreludeDx. "By integrating RNA expression and spatial proteomic expression, AidaBREAST is designed to capture multiple dimensions of tumor biology."

• 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 radiation therapy.
• Women in the Low Risk group demonstrated low 10-year recurrence rates whether or not they received radiation therapy.

Extending the Proven Impact of DCISionRT®

AidaBREAST builds on PreludeDx's leadership established with DCISionRT®, the widely adopted test that transformed radiation therapy decision-making for women diagnosed with ductal carcinoma in situ (DCIS). AidaBREAST marks PreludeDx's second FDA Breakthrough Device designation, following DCISionRT, further reinforcing the company's commitment to delivering biologically driven decision-support tools across the continuum of early-stage breast cancer care.

About AidaBREAST for Early-Stage Breast Cancer

AidaBREAST is the only clinical risk assessment test for patients with stage I,IIa breast cancer that predicts radiation therapy benefit. The next-generation multi-omic assay developed by PreludeDx uses advanced spatial biology technology combining multiplex protein expression with targeted next-generation RNA sequencing to provide a comprehensive assessment of a patient's tumor biology. Leveraging the power of artificial intelligence, the assay integrates these complex data to generate a patient's individualized risk assessment for 10-year locoregional recurrence and predict their benefit from radiation therapy. This innovative approach enables physicians to move beyond traditional measures offering patients personalized results with new insights into recurrence risk and radiation therapy benefit. This new information helps patients and their physicians to make more informed treatment decisions.

About PreludeDx

PreludeDx is a leading personalized breast cancer diagnostics company serving patients and physicians worldwide. Founded in 2009 with technology from the University of California San Francisco, PreludeDx is dedicated to developing precision breast cancer tools that impact treatment decisions. The company's mission is to provide innovative technologies that improve patient outcomes and reduce healthcare costs. Before making a treatment decision, Know Your Risk™, Know Your Benefit. For more information on how PreludeDx is making a difference for patients, please visit the Company's website: https://preludedx.com and follow us on X, LinkedIn, Instagram and Facebook.

Media Contact
Martin Sandgren
Klover Communications
[email protected]

Investor Contact
Andrew Wade
PreludeDx
[email protected] 

SOURCE Prelude Corporation