The analysis evaluates outcomes in muscle-invasive bladder cancer (MIBC) patients who tested serially negative with Signatera, Natera's personalized and tumor-informed molecular residual disease (MRD) test.
Sponsored by
The analysis presented at the
Disease-free survival (DFS) rates of 92% at 12 months and 88% at 18 months, in patients who remained serially MRD-negative.
Concludes that patients who remain MRD-negative on serial testing may be spared from adjuvant treatment.
'IMvigor011 is an important randomized study that is designed to address a critical unmet need for the more than 35,000 patients a year diagnosed with muscle-invasive bladder cancer,' said
This presentation follows a study published in Nature based on the phase III randomized IMvigor010 trial, which showed that patients who tested Signatera MRD-positive after radical cystectomy received significant benefit from adjuvant immunotherapy with atezolizumab, while Signatera-negative patients derived no significant benefit from adjuvant therapy.
As previously announced in
About Signatera
Signatera is a personalized, tumor-informed, molecular residual disease test for patients previously diagnosed with cancer. Custom-built for each individual, Signatera uses circulating tumor DNA to detect and quantify cancer left in the body, identify recurrence earlier than standard of care tools, and help optimize treatment decisions. The test is available for clinical and research use and is covered by Medicare for patients with colorectal cancer, breast cancer, ovarian cancer and muscle-invasive bladder cancer, as well as for immunotherapy monitoring of any solid tumor. Signatera has been clinically validated across multiple cancer types and indications, with published evidence in more than 50 peer-reviewed papers.
About Natera
Natera is a global leader in cell-free DNA testing, dedicated to oncology, women's health, and organ health. We aim to make personalized genetic testing and diagnostics part of the standard of care to protect health, and inform earlier, more targeted interventions that help lead to longer, healthier lives. Natera's tests are validated by more than 180 peer-reviewed publications that demonstrate high accuracy. Natera operates ISO 13485-certified and CAP-accredited laboratories certified under the Clinical Laboratory Improvement Amendments (CLIA) in
Forward-Looking Statements
All statements other than statements of historical facts contained in this press release are forward-looking statements and are not a representation that Natera's plans, estimates, or expectations will be achieved. These forward-looking statements represent Natera's expectations as of the date of this press release, and Natera disclaims any obligation to update the forward-looking statements. These forward-looking statements are subject to known and unknown risks and uncertainties that may cause actual results to differ materially, including with respect to whether the results of clinical or other studies will support the use of our product offerings, the impact of results of such studies, our expectations of the reliability, accuracy and performance of our tests, or of the benefits of our tests and product offerings to patients, providers and payers.
Contact:
Tel: 510-826-2350
Email: investor@natera.com
Email: pr@natera.com
(C) 2024 Electronic News Publishing, source