The AidaBREAST assay uses multi-omic data and artificial intelligence to predict recurrence risk and radiation therapy benefit for patients with early-stage invasive breast cancer.
Prelude Corp (PreludeDx) has received Breakthrough Device designation from the US Food and Drug Administration (FDA) for its AidaBREAST test, a precision diagnostic for early-stage invasive breast cancer.
AidaBREAST provides individualized prognostic risk assessment and predicts the benefit of radiation therapy for women diagnosed with stage I or IIa invasive breast cancer. The assay integrates multi-omic data to generate a patient-specific assessment of 10-year locoregional recurrence risk and the potential benefit of adjuvant radiation therapy following breast-conserving surgery.
“AidaBREAST addresses an important need in early-stage invasive breast cancer by providing both recurrence risk assessment and insight into which patients are most likely to benefit from radiation therapy,” says Dan Forche, CEO of PreludeDx, in a release. “With Breakthrough Device designations for both DCISionRT and AidaBREAST, we are continuing to advance precision diagnostics that support more informed treatment decisions for patients and physicians.”
The test utilizes spatial biology technology that combines multiplex protein expression with targeted next-generation RNA sequencing to provide a “comprehensive assessment” of a patient’s tumor biology, according to the company. The assay uses artificial intelligence to integrate these data points, providing insights into recurrence risk and radiation therapy benefit that move beyond traditional measures.
The FDA Breakthrough Device designation is reserved for medical devices that provide more effective treatment or diagnosis of life-threatening or irreversibly debilitating diseases and offer significant advantages over existing approved or cleared alternatives. This status provides priority review by the FDA, which can shorten the timeline for bringing new technologies to patients.
“We look forward to working closely with the FDA as we advance AidaBREAST through the regulatory process and remain committed to expanding access to precision diagnostic tools that improve outcomes for patients with early-stage breast cancer,” says Forche, CEO of PreludeDx, in a release.
The AidaBREAST designation marks the second Breakthrough Device for PreludeDx, following the designation of its DCISionRT test.
