FDA Approves Natera's Signatera as CDx for Bladder Cancer Immunotherapy
The clearance marks the first FDA approval of a blood-based minimal residual disease test as a companion diagnostic.
Natera has received FDA approval for Signatera CDx as a companion diagnostic for use with Genentech’s Tecentriq (atezolizumab) immunotherapy in muscle-invasive bladder cancer (MIBC).
The approval, announced May 15, marks the first time a blood-based molecular minimal residual disease (MRD) test has been cleared as a companion diagnostic. The decision allows clinicians to use circulating tumor DNA MRD status to guide treatment decisions: initiating immunotherapy in MRD-positive patients and potentially deferring treatment in those who test negative.
The approval follows publication of the Phase III IMvigor011 trial in the New England Journal of Medicine in October 2025.
https://www.nejm.org/doi/full/10.1056/NEJMoa2511885
“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,” Thomas Powles, principal investigator of the IMvigor011 trial and chair of the UK’s Barts Cancer Centre at St. Bartholomew’s Hospital, said in a statement. “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.”
The Genentech-sponsored trial found that MIBC patients who tested positive on Signatera and received immunotherapy achieved significant improvements in disease-free survival and overall survival. MRD-negative patients who received no adjuvant therapy achieved 97 percent two-year overall survival.
How much this therapy will be prescribed, however, remains to be seen. Approximately 30,000 new MIBC cases are diagnosed annually in the U.S. and 150,000 globally. Surgery achieves long-term disease control in roughly half of patients, but identifying which patients are likely to recur has historically been difficult.
“While IMvigor011 is a practice changing trial in theory, key opinion leaders noted that the standard of care continues to evolve, and that as more patients receive neoadjuvant treatment fewer will also require adjuvant treatment after surgery,” Guggenheim Securities Analyst Subbu Nambi wrote in a May 15 note to investors. “Therefore, while [they] are positive on the IMvigor011 trial, they have been less optimistic as to how much this therapy will be used in practice.”
The news comes a week after Austin, Texas-based Natera reported first quarter revenue of $696.6 million, up 39 percent year over year from $501.8 million in Q1 2025.
Oncology testing was up more than 50 percent to 258,900 tests from 167,700 in the year ago quarter.
Natera has a growing portfolio of trials examining treatment based on MRD testing, including the DARE trial for estrogen receptor-positive, HER2-negative breast cancer and ALTAIR for colorectal cancer.