PreludeDx’s AidaBREAST Test Earns FDA Breakthrough Device Designation
Prelude Corporation (PreludeDx), a precision‑diagnostics company focused on early‑stage breast cancer, received FDA Breakthrough Device designation for its AidaBREAST test. This is the company’s second Breakthrough Device; its DCISionRT test for ductal carcinoma in situ previously received the same status.
What AidaBREAST does for early‑stage invasive breast cancer
AidaBREAST provides an individualized risk assessment for people diagnosed with early‑stage (stage I and IIa) invasive breast cancer after breast‑conserving surgery. The test estimates a person’s 10‑year risk of locoregional breast cancer recurrence and predicts how much benefit they are likely to receive from adjuvant radiation therapy.
Why this test is different
AidaBREAST is currently the only risk‑assessment test for stage I–IIa invasive breast cancer that predicts both recurrence risk and radiation therapy benefit in a single assay. The assay uses a multi‑omic, spatial‑biology platform that combines multiplex protein expression with targeted next‑generation RNA sequencing to capture detailed tumor biology beyond standard clinicopathologic features.
What FDA Breakthrough Device status means
The FDA’s Breakthrough Devices Program is intended for technologies that may offer more effective diagnosis or treatment for serious conditions and may provide significant advantages over existing options. Breakthrough Devices receive prioritized FDA review and enhanced communication, which can help shorten the time it takes to bring new diagnostic tools like AidaBREAST to the people who could benefit.
Potential impact on treatment decisions
By identifying individuals who have a low risk of recurrence and limited radiation benefit, as well as those who have higher risk and substantial benefit, AidaBREAST may help prevent both over‑ and under‑treatment with radiation therapy. The test supports more personalized, shared decision‑making between clinicians and people with breast cancer, aligning treatment intensity with each person’s tumor biology and long‑term risk profile.
