On February 2, 2026 Natera, Inc. (NASDAQ: NTRA), a global leader in cell-free DNA and precision medicine, reported the submission of its premarket approval (PMA) to the U.S. Food and Drug Administration (FDA) for Signatera CDx for detection of molecular residual disease (MRD) in patients with muscle-invasive bladder cancer (MIBC) who may benefit from treatment with atezolizumab (Tecentriq).
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This submission is supported by data from the randomized, double-blind, phase 3 IMvigor011 clinical trial, which met its primary endpoint and demonstrated the benefits of Signatera-guided therapy in MIBC. In the study, Signatera-positive patients treated with atezolizumab (Tecentriq) had statistically significant and clinically meaningful improvements in disease-free survival and overall survival, compared with placebo. The trial also showed that Signatera-negative patients had a low risk of recurrence without adjuvant immunotherapy. Results were featured in a Presidential Symposium at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Congress on October 20, 2025, with a concurrent publication in The New England Journal of Medicine.
Bladder cancer is the sixth most common cancer in the United States1 and MIBC represents 20-25% of the newly diagnosed cases.2 Radical cystectomy (with or without neoadjuvant therapy) is curative for approximately half of these patients, but until now it has been very challenging to identify which patients are likely to recur and to offer them effective, personalized therapy while sparing the others from unnecessary treatment.3,4 The IMvigor011 trial, sponsored by Genentech, a member of the Roche Group, was designed to address that challenge.
"Submitting this PMA represents an important step toward making MRD-guided treatment a reality for patients with muscle-invasive bladder cancer," said Alexey Aleshin, M.D., general manager of oncology and corporate chief medical officer at Natera. "If approved, we believe Signatera CDx has the potential to be the first companion diagnostic MRD test that helps guide treatment decisions and improve outcomes for patients."
(Press release, Natera, FEB 2, 2026, View Source [SID1234662414])