Austin, TX /PRNewswire/ - Natera, Inc. (NASDAQ: NTRA), a global leader in cell-free DNA (cfDNA) testing, today announced that it was awarded a nationwide contract, effective Sept. 15, 2022, with the U.S. Department of Veterans Affairs (VA) National Precision Oncology Program, to provide minimal residual disease (MRD) and monitoring services with the company's personalized and tumor-informed MRD test, Signatera™.
The VA is the largest integrated health system in the country, providing care to over 450,000 veterans living with cancer.1 Through this contract the Signatera™ test will be made available for serial use, to help detect residual disease and inform difficult treatment decisions. Signatera™ is covered by Medicare for use in colorectal cancer, muscle invasive bladder cancer, and pan-cancer immunotherapy monitoring, and has been validated across multiple cancer types to detect recurrence earlier than standard diagnostic tools2,3 and to help assess treatment response in conjunction with imaging.4 Data supporting the clinical validity and utility of Signatera™ has been published in 35 peer-reviewed publications.
"We are proud to partner with the VA to make Signatera accessible to our nation's veterans," said Solomon Moshkevich, general manager of oncology at Natera. "We look forward to working with the VA and other integrated health systems around the country to integrate Signatera into standard clinical practice, with the goal of improving clinical outcomes and reducing the costs associated with unnecessary treatment."
Signatera™ is a custom-built circulating tumor DNA (ctDNA) test for treatment monitoring and molecular residual disease (MRD) assessment in patients previously diagnosed with cancer. The test is available for both clinical and research use, and has been granted three Breakthrough Device Designations by the FDA for multiple cancer types and indications. The Signatera™ test is personalized and tumor-informed, providing each individual with a customized blood test tailored to fit the unique signature of clonal mutations found in that individual's tumor. Signatera™ is intended to detect and quantify any cancer left in the body, at levels down to a single tumor molecule in a tube of blood, to identify recurrence earlier and to help optimize treatment decisions.
NateraTM is a global leader in cell-free DNA testing, dedicated to oncology, women's health, and organ health. Our aim is to make personalized genetic testing and diagnostics part of the standard of care to protect health and enable earlier and more targeted interventions that help lead to longer, healthier lives. Natera's tests are validated by more than 100 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 Austin, Texas and San Carlos, California. For more information, visit www.natera.com.
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 our ability to perform our contractual obligations under the agreement with the VA, the quotes of management, 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. Additional risks and uncertainties are discussed in greater detail in "Risk Factors" in Natera's recent filings on Forms 10-K and 10-Q and in other filings Natera makes with the SEC from time to time. These documents are available at www.natera.com/investors and www.sec.gov.
- U.S. Department of Veterans Affairs, National Precision Oncology Program (NPOP) Program Guide.
- Reinert T, Henriksen TV, Christensen E, et al. Analysis of plasma cell-free DNA by ultradeep sequencing in patients with stages I to III colorectal cancer. JAMA Oncol. 2019;5(8):1124–1131.
- Coombes RC, Page K, Salari R, et al. Personalized detection of circulating tumor DNA antedates breast cancer metastatic recurrence. Clin Cancer Res. 2019;25(14):4255-426.
- Bratman SV, Yang SYC, Iafolla MAJ, et al. Personalized circulating tumor DNA analysis as a predictive biomarker in solid tumor patients treated with pembrolizumab. Nat. Cancer. 2020;1(9):873-881.