Morningstar

Natera Gets FDA Approval for Bladder-Cancer Test

Provided by Dow Jones May 15, 2026, 5:25:00 PM

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 katherine.hamilton@wsj.com

(END) Dow Jones Newswires

May 15, 2026 13:25 ET (17:25 GMT)

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