FDA awards Breakthrough designation to Prelude’s AidaBREAST for personalized breast cancer care
Prelude Corporation's AidaBREAST, a prognostic test for early-stage invasive breast cancer, has received FDA Breakthrough Device designation, promising personalized risk assessments to guide treatment decisions.
Prelude Corporation’s prognostic risk assessment for breast cancer has been awarded U.S. Food and Drug Administration (FDA) Breakthrough Device designation, according to an announcement.
The test, AidaBREAST, informs early-stage invasive breast cancer patients and their clinicians of the patient’s disease recurrence risk and if they might benefit from radiation therapy after receiving breast-conserving surgery. The test utilizes multi-omic data to develop “patient-specific assessments.”
The FDA’s designation should lead to personalized healthcare for these patients, according to Prelude.
