On September 22, Natera announced that Signatera had received approval in Japan as a companion diagnostic for postoperative treatment of muscle-invasive bladder cancer. The test uses information from a patient's tumor to track cancer-derived DNA in the blood and inform decisions about additional treatment. Company announcement ↗

Whereas histopathology examines the appearance of tissues and cells, Signatera looks for DNA variants identified in a patient's tumor in blood collected after surgery. It is designed to detect molecular traces of residual cancer, even before lesions become visible on imaging. FDA device information ↗

In the trial supporting this use, patients who tested positive after surgery had longer disease-free and overall survival with atezolizumab than with placebo. Clinical trial ↗

The test discussed in “Can Shield Bring More People into Colorectal Cancer Screening?” ↗ was intended to direct people with suspected cancer toward further diagnostic investigation. This use concerns additional treatment for patients who have already undergone surgery. It brings blood testing and drug treatment together, using evidence of residual disease to inform the next treatment decision.

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Signatera: Using Tumor DNA in Blood to Guide Treatment After Surgery

Natera announced Japanese companion-diagnostic approval; additional treatment in test-positive patients has been assessed in a comparative trial.

  1. Reports and agreements reviewedRecorded
  2. Further validationUnverified
  3. Adoption and benefitUnverified
NEXT CHECK

Track the authorized population and treatment conditions.

Hypothesis and what would change it

Evidence linking a test to treatment may make postoperative treatment decisions more specific.

What would change our view: Reassess the expected benefit when trial or patient conditions differ.

The setting is postoperative muscle-invasive bladder cancer; do not generalize to test-negative patients or other cancers.

Evidence, organizations & history →

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Evidence & reading

Public sources checked for this edition. Linked pages may subsequently change.

  1. 企業発表 ↗www.natera.com · recorded 2026-09-29
  2. FDAの検査情報 ↗www.accessdata.fda.gov · recorded 2026-09-29
  3. 臨床試験 ↗pubmed.ncbi.nlm.nih.gov · recorded 2026-09-29

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