Natera announced on February 2, 2026 that it has submitted a Premarket Approval (PMA) application to the U.S. FDA for Signatera™ CDx to detect molecular residual disease (MRD) in muscle-invasive bladder cancer (MIBC) patients who may benefit from atezolizumab (Tecentriq®).
For background on IMvigor011 and the earlier topline readout, see our prior OncoDaily coverage.
What’s new: a formal FDA filing backed by peer-reviewed phase 3 evidence
According to Natera, the PMA submission is supported by the randomized, double-blind phase 3 IMvigor011 dataset and comes after the trial’s full results were presented at ESMO 2025 with a concurrent publication in The New England Journal of Medicine.
This is a concrete step beyond the company’s earlier statement (August 2025) that it planned to finalize and file a PMA for a bladder cancer companion diagnostic claim.
Timeline in three dates
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Aug 18, 2025: Natera reported positive topline IMvigor011 results and said it would finalize a PMA for Signatera as a companion diagnostic in MIBC.
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Oct 20, 2025: IMvigor011 data were showcased at ESMO (Presidential Symposium) and published in NEJM.
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Feb 2, 2026: Natera announced the PMA submission to the FDA for Signatera CDx in MIBC.
What Natera is asking the FDA to clear
Natera’s filing seeks PMA approval for Signatera CDx as a companion diagnostic MRD test in MIBC specifically in the context of selecting patients who may benefit from Tecentriq (atezolizumab).
Two regulatory terms matter here:
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PMA (Premarket Approval): FDA describes PMA as the most stringent type of medical device marketing application, requiring sufficient valid scientific evidence to assure safety and effectiveness for the intended use.
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Companion diagnostic (CDx): FDA defines a companion diagnostic as a device (often an in vitro diagnostic) that provides information essential for the safe and effective use of a corresponding drug or biologic.
In plain terms, Natera is pursuing the highest-level device review pathway for a test intended to guide a specific drug decision in bladder cancer.
Why this submission is a meaningful inflection point?
Natera is positioning Signatera CDx as potentially first-in-class. As Alexey Aleshin, MD, Natera’s oncology and corporate chief medical officer, said:
“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.”
Alexey Aleshin, M.D./LinkedIn
He added that submitting the PMA is an important step toward making MRD-guided treatment a reality for patients with muscle-invasive bladder cancer.
The key shift here is not another topline update, it’s the move into:
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peer-reviewed publication, and
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a formal FDA review process aimed at an on-label companion diagnostic claim.
What to watch next
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FDA acceptance and review progress (including any requests for additional analyses or clarification typical of PMA review).
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Final labeling language: exactly how the test is indicated, and how results should be used to guide Tecentriq treatment decisions.
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Clinical adoption mechanics after any approval: integration into clinical pathways, payer coverage decisions, and alignment with institutional testing workflows (often decisive for CDx uptake).
If the FDA clears the PMA, Signatera CDx could move MRD testing in MIBC from an evidence-backed strategy to an on-label companion diagnostic pathway for selecting atezolizumab. OncoDaily will update as the FDA review and final labeling become available.