FDA approves Signatera as companion diagnostic for muscle-invasive bladder cancer, the first MRD test to achieve this designation

Natera/Signatera

The FDA approved Signatera as a companion diagnostic for patients with muscle-invasive bladder cancer, guiding adjuvant treatment decisions based on MRD status. This marked the first FDA approval of an MRD test as a companion diagnostic, validating the Treatment on MRD (TOMR) approach and expanding Signatera's clinical role.

• Approval allows Signatera to guide whether bladder cancer patients should receive additional chemotherapy after surgery.
• Retrospective data showed that MRD-positive patients benefited substantially from adjuvant therapy, while MRD-negative patients had excellent outcomes regardless of additional treatment.
• Sets regulatory precedent for MRD testing in other solid tumors.