PreludeDx Receives FDA Breakthrough Device Designation for AidaBreast Multi-Omic Test in Early-Stage Breast Cancer
核心洞察
PreludeDx (搜索) received FDA Breakthrough Device designation for AidaBreast (搜索), a multi-omic test that predicts radiation therapy benefit and 10-year locoregional recurrence risk in early-stage invasive breast cancer.
The designation follows publication of validation study results in Breast Cancer Research demonstrating AidaBreast (搜索)'s ability to identify patients who may not benefit from radiation therapy and those with significant benefit.
AidaBreast (搜索) represents the first test designed to provide both prognostic assessment and predictive insight for radiation therapy decisions in early-stage invasive breast cancer.
PreludeDx (搜索) announced that the U.S. Food and Drug Administration has granted Breakthrough Device designation for the AidaBreast (搜索) test, marking a significant milestone for precision diagnostics in early-stage invasive breast cancer. The designation comes following publication of validation study results in Breast Cancer Research that demonstrated the test's unique ability to both predict radiation therapy benefit and assess 10-year locoregional recurrence risk.
Multi-Institutional Validation Study Results
The published study evaluated 922 hormone receptor-positive, HER2-negative invasive breast cancer patients treated with breast-conserving surgery across four academic and clinical centers in the United States and Sweden, with a median follow-up of 10 years. The research demonstrated that AidaBreast (搜索) 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.
"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."
Advanced Multi-Omic Technology Platform
AidaBreast (搜索) integrates targeted NextGen RNA expression with multiplex protein biomarker expression and spatial biology to provide comprehensive tumor assessment. The test uses advanced spatial biology technology combining multiplex protein expression with targeted next-generation RNA sequencing, leveraging artificial intelligence to integrate complex data and generate individualized risk assessments.
"By integrating the multiplex platform and spatial biology, AidaBreast (搜索) captures complementary dimensions of tumor biology that cannot be assessed through clinicopathologic features alone," said Troy Bremer, PhD, Chief Scientific Officer of PreludeDx (搜索). "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."
Clinical Applications and Patient Selection
The test is designed for women with early-stage (I, IIa) invasive breast cancer and provides three key clinical benefits: predicting radiation therapy benefit after breast-conserving surgery, offering prognostic assessment for 10-year locoregional recurrence risk, and helping prevent over- and undertreatment of early-stage disease.
The study findings suggest that AidaBreast (搜索) may enable clinicians to escalate and de-escalate therapy based on molecular biology, providing information not available from clinicopathology alone. This approach supports more informed, shared decision-making between physicians and patients regarding radiation therapy use.
Regulatory Pathway and Company Portfolio
The FDA's Breakthrough Device designation is reserved for medical devices that provide more effective treatment or diagnosis and offer significant advantages over existing alternatives. The designation provides priority review, potentially shortening the time to bring the technology to patients.
"With Breakthrough Device designations for both DCISionRT (搜索) and AidaBREAST (搜索), we are continuing to advance precision diagnostics that support more informed treatment decisions for patients and physicians," said Dan Forche, President and CEO of PreludeDx (搜索).
This marks PreludeDx (搜索)'s second FDA Breakthrough Device designation, following DCISionRT (搜索) for ductal carcinoma in situ. DCISionRT has already transformed radiation therapy decision-making for women diagnosed with DCIS, with over 60,000 women newly diagnosed with DCIS annually in the United States.
Impact on Precision Medicine
The validation study results and FDA designation position AidaBreast (搜索) as a significant advancement in personalized breast cancer care. As breast cancer treatment continues to shift toward personalization, multi-omic approaches that integrate personalized tumor biology may help better align treatment intensity with individual patient risk.
"The publication of this study represents an important milestone not only for Aida, but for PreludeDx (搜索) as a whole," said Forche. "With DCISionRT (搜索) transforming radiation decision-making in DCIS and AidaBreast (搜索) extending biologic precision into early-stage invasive breast cancer, PreludeDx is uniquely positioned to lead the evolution of personalized radiation therapy decisions."