Natera, Inc. today announced that the U.S. FDA has approved Signatera CDx as a companion diagnostic (CDx) for use with adjuvant atezolizumab (Tecentriq) immunotherapy in Muscle-Invasive Bladder Cancer (MIBC).

According to the company press release, this is the first companion diagnostic approval in the field of blood-based MRD. It is a significant milestone in the industry-wide shift toward personalized, MRD-guided cancer care, in which treatment decisions may depend on Signatera™ MRD status, and interventions may be delayed or deferred for patients who remain MRD-negative. Supported by more than 185 peer-reviewed publications and Medicare coverage across multiple cancer types (including Bladder, Breast, Lung, Colorectal, Ovarian, and pan-cancer immunotherapy monitoring), Signatera has become a cornerstone of precision oncology.

Signatera CDx has been approved by the FDA for use with adjuvant atezolizumab (Tecentriq) to identify patients with MIBC who are ctDNA MRD-positive and may benefit from treatment. This follows The New England Journal of Medicine publication in October 2025 of the landmark, global Phase III IMvigor011 trial, sponsored by Genentech. The trial results demonstrated that Signatera MRD-positive patients treated with immunotherapy achieved significant improvements in disease-free survival (DFS) and overall survival (OS), while Signatera MRD-negative patients achieved 97% 2-year OS with no adjuvant therapy at all.

“The practice-changing IMvigor011 trial and this approval signal a transformation in cancer care, where MRD is guiding when to treat, whom to treat, and how to treat more precisely,” said Professor Thomas Powles, lead principal investigator of IMvigor011 and Chair of Barts Cancer Centre at St. Bartholomew’s Hospital. “Historically, we relied on imaging to tell us when cancer had returned, but that also meant millions of cancer cells were already present in the body. As we saw with IMvigor011 and in several other trials, Signatera detected tumor DNA at an earlier timepoint and provided us with a significant head start to improve outcomes for patients.”

“For bladder cancer patients and families, the period after bladder removal can be filled with uncertainty,” said Meri-Margaret Deoudes, CEO of the Bladder Cancer Advocacy Network. “Approaches like Signatera can help clarify which patients are more likely to experience recurrence, giving clinicians additional important information as they consider next steps. Our priority is ensuring that patients and families have access to tools that support informed decision-making, reduce unnecessary treatment when possible, and help guide timely care when it’s needed.”