Natera Files Signatera CDx PMA With FDA for Bladder Cancer MRD Test

Key Takeaways Natera filed an FDA PMA for Signatera CDx to guide adjuvant therapy in bladder cancer.Phase 3 IMvigor011 trial showed MRD-positive patients benefit from Tecentriq.Approval could expand Signatera adoption, boost Natera revenue and strengthen its precision oncology position.Natera (NTRA) recently announced the submission of a premarket approval (PMA) application to the FDA for its Signatera CDx test, a personalized molecular residual disease (MRD) assay for patients with muscle-invasive bladder ...