Natera Gets FDA Approval for Bladder-Cancer Test

Published: 2026-05-15 13:26:15 ET NTRA

Published on 05/15/2026 at 01:26 pm EDT

By Katherine Hamilton

Natera said the Food and Drug Administration approved its Signatera CDx as a test for bladder cancer.

The drug can be used as a companion diagnostic with adjuvant atezolizumab to treat muscle-invasive bladder cancer, the Austin, Texas, company said Friday.

The approval came after a trial showed patients tested positive with Signatera and treated with immunotherapy achieved significant improvements in disease-free survival and overall survival, Natera said.

Patients who tested negative with Signatera achieved 97% two-year overall survival with no adjuvant therapy, the company said.

It has historically been difficult to identify which patients are likely to have recurring muscle-invasive bladder cancer, Natera said, making it difficult to spare patients from unnecessary treatment while treating those who do need it.

Write to Katherine Hamilton at [email protected]

(END) Dow Jones Newswires

05-15-26 1325ET