Data show the test can predict both locoregional recurrence risk and radiation therapy benefit in early-stage invasive breast cancer.
PreludeDx has announced the publication of a large, multi-institutional validation study of its AidaBreast test in the journal Breast Cancer Research, with data showing the test can predict both locoregional recurrence risk and radiation therapy benefit in early-stage invasive breast cancer.
The study 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 US and Sweden, with a median follow-up of 10 years. AidaBreast integrates targeted next-generation RNA expression with multiplex protein biomarker expression and spatial biology to assess both recurrence risk and differential benefit from radiation therapy, according to the company.
Key findings from the study:
The study demonstrates that the AidaBreast test may better inform individualized shared decision-making for radiation therapy treatment.
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 radiation therapy.
The test provided information not available from clinicopathology and may enable clinicians to escalate and de-escalate therapy based on molecular biology.
“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,” says Naamit Gerber, MD, radiation oncologist at NYU Langone Health’s Perlmutter Cancer Center and co-author of the study, in a release. “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.”
A Multi-Omic Approach to Tumor Biology
AidaBreast is designed to capture tumor characteristics that cannot be assessed through clinicopathologic features alone, according to PreludeDx. By combining multiple biological measurement approaches into a single assay, the test aims to provide both prognostic and predictive insight for clinicians managing early-stage invasive breast cancer patients.
“By integrating the multiplex platform and spatial biology, AidaBreast captures complementary dimensions of tumor biology that cannot be assessed through clinicopathologic features alone,” says Troy Bremer, PhD, chief scientific officer of PreludeDx, in a release. “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 an Established Diagnostic Portfolio
AidaBreast builds on PreludeDx’s existing test, DCISionRT, which the company describes as the only risk assessment test for patients with ductal carcinoma in situ (DCIS) that predicts radiation therapy benefit. More than 60,000 women in the US are newly diagnosed with DCIS each year, according to the company. DCISionRT combines protein expression from seven biomarkers and four clinicopathologic factors using a non-linear algorithm to provide recurrence risk scores and radiation therapy benefit information.
“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,” says Dan Forche, president and chief executive officer of PreludeDx, in a release.
The company says that 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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