Natera (NASDAQ:NTRA) submitted a formal application for U.S. regulatory approval of its Signatera molecular residual disease test as a companion diagnostic for bladder cancer, moving to solidify its lead in the burgeoning field of precision oncology.
The submission to the Food and Drug Administration (FDA) aims to clear the test for use in identifying muscle-invasive bladder cancer patients who are most likely to benefit from Roche Holding AG’s immunotherapy Tecentriq.
The application is underpinned by data from the Phase 3 IMvigor011 clinical trial, which found that patients testing positive for residual disease with Signatera saw statistically significant improvements in survival when treated with the immunotherapy.
Conversely, patients who tested negative showed a low risk of cancer recurrence even without additional treatment, suggesting the test could help thousands avoid the toxicity of unnecessary chemotherapy.
The results were featured at the European Society for Medical Oncology Congress in October and published in the New England Journal of Medicine.
The move marks a critical step for Natera as it looks to transition Signatera from a laboratory-developed test into a widely recognized, FDA-cleared diagnostic.
Bladder cancer is the sixth most common cancer in the U.S., and roughly a quarter of cases are muscle-invasive, a stage where doctors have historically struggled to predict which patients require aggressive follow-up care after surgery.
If approved, Signatera would become the first companion diagnostic of its kind for this patient population.