LAGUNA HILLS, Calif., Mar 12th: Prelude Corporation (PreludeDx®), a leader in precision diagnostics for early-stage breast cancer, announced today the publication of results from a large, multi-institutional validation study of the AidaBreast™ test in Breast Cancer Research. The groundbreaking data demonstrated the test to be both prognostic for 10-year recurrence risk and predictive for radiation therapy benefit.

“For decades, radiation decisions in early-stage invasive breast cancer have relied primarily on clinicopathologic features, which do not fully capture the biological behavior of an individual tumor,” said Dr. Naamit Gerber, Radiation Oncologist at NYU Langone Health’s Perlmutter Cancer Center and co-author of the study. “Aida™ is the first and only test designed to provide both prognostic assessment of locoregional recurrence risk and predictive insight into radiation therapy benefit. This type of biologic information has not previously been available to guide radiation decision-making and represents an important advancement toward truly personalized care.”

In the published study, investigators evaluated 922 hormone receptor-positive (HR+), HER2-negative invasive women treated with breast-conserving surgery, with and without adjuvant radiation therapy, across four academic and clinical centers in the United States and Sweden, with a median follow-up of 10 years. AidaBreast integrates targeted NextGen RNA expression with multiplex protein biomarker expression and spatial biology to provide insight into both recurrence risk and differential benefit from radiation therapy.

“The publication of this study represents an important milestone not only for Aida™, but for PreludeDx as a whole,” said Dan Forche, President and CEO of PreludeDx. “With DCISionRT transforming radiation decision-making in DCIS and AidaBreast extending biologic precision into early-stage invasive breast cancer, PreludeDx is uniquely positioned to lead the evolution of personalized radiation therapy decisions. Our portfolio reflects a long-term commitment to delivering clinically actionable biology across the continuum of early-stage breast cancer care.”

Key Findings from the Multi-Institutional Study

  1. The study demonstrates that the AidaBreast test may better inform individualized shared decision-making for radiation therapy treatment.
  2. AidaBreast identified a low risk group of patients who did not have a statistically significant benefit from radiation therapy and a subset of patients who had a targeted and significant benefit from RT.
  3. The test provided information not available from clinicopathology and may enable clinicians to escalate and de-escalate therapy based on molecular biology.

“This publication validates the strength of our multi-omic platform,” said Troy Bremer, PhD, Chief Scientific Officer of PreludeDx. “By integrating the multiplex platform and spatial biology, AidaBreast captures complementary dimensions of tumor biology that cannot be assessed through clinicopathologic features alone. The ability to provide both prognostic and predictive insight from a single assay reflects the next evolution of precision medicine in early-stage invasive breast cancer.”

Building on 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). Together, DCISionRT and AidaBreast reflect PreludeDx’s strategy to provide biologically driven decision support tools across the spectrum of early-stage breast cancer.

Advancing Precision in Early-Stage Invasive Breast Cancer

As breast cancer care continues to shift toward personalization, multi-omic approaches that integrate personalized tumor biology may help better align treatment intensity with individual patient risk. Upon further validation, AidaBreast has the potential to support more informed, shared decision-making between physicians and patients regarding the use of radiation therapy.

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