NTRA News & Events

Natera announced the submission of its premarket approval, or PMA, to the FDA for Signatera CDx for detection of molecular residual disease, or MRD, in patients with muscle-invasive bladder cancer, or MIBC, who may benefit from treatment with atezolizumab, or Tecentriq. 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 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 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 U.S. and MIBC represents 20%-25% of the newly diagnosed cases.

Natera announced the completion of enrollment in ACES-EMB, the first randomized-controlled trial evaluating whether Natera's Prospera Heart test can replace routine invasive biopsies for rejection monitoring in heart transplant recipients.

Natera announced the publication of a new prospective clinical trial in Transplantation Direct. The study, which was conducted by The Ohio State University Wexner Medical Center, was initiated to explore whether donor-derived cell-free DNA surveillance, and specifically Prospera-guided monitoring, could reduce the number of invasive biopsies for patients following lung transplantation. As transplant volumes increased at OSU-WMC, the center launched a quality assurance and performance improvement initiative to evaluate whether the Prospera test could allow them to safely eliminate the 9-month surveillance biopsy. In the study, 78 lung-transplant recipients were monitored with the Prospera test for one year post-transplant. Physicians chose to omit the 9-month biopsy in ~75% of patients with low-risk Prospera results. For these patients over the ensuing 3 months, there was no significant difference in acute rejection rates, spirometry indices, or donor-specific antibodies compared to patients who underwent the procedure. At one year post-transplant, approximately 95% of patients who omitted the 9-month biopsy did not have acute rejection that needed any treatment. Patients who omitted the 9-month biopsy maintained lung function and immunologic stability similar to those who underwent the procedure.

Natera announced the publication in npj Precision Oncology of the validation study for its Latitude tissue-free molecular residual disease assay, or tfMRD, in colorectal cancer, or CRC. The peer-reviewed publication builds upon data that was previously presented at the 2025 European Society for Medical Oncology GI Congress, or ESMO GI. The study analyzed 1,230 timepoints from 195 CRC patients who participated in the GALAXY clinical trial, one of the largest and most comprehensive tfMRD studies in resectable CRC. The scale and rigor of this dataset, combined with excellent clinical performance, provides support for submission to the Centers for Medicare & Medicaid Services' Molecular Diagnostics Services Program. Key findings from the publication include: High sensitivity: longitudinal sensitivity of 84.4%, with median lead time of 4.6 months ahead of radiographic recurrence; high specificity: 97.2% sample-level specificity and 92.1% patient-level specificity, providing strong actionability when an MRD-positive is observed; robust prognostic value: MRD-positivity was associated with worse outcomes in both the MRD and surveillance settings; clear predictive value for adjuvant chemotherapy benefit: In high-risk stage II and stage III patients, those who were MRD-positive following surgery experienced a significant benefit from ACT, compared to MRD-negative patients, who observed no meaningful treatment benefit. Latitude is a methylation-based test that detects circulating tumor DNA without the need for tumor tissue.