Signatera™ Wins Fierce Life Sciences Innovation Award
Natera's personalized MRD test selected as winner in the Medical Device Innovation category
AUSTIN, Texas, Jan. 3, 2022 /PRNewswire/ — Natera, Inc. (NASDAQ: NTRA), a leader in personalized genetic testing and diagnostics, today announced that its personalized molecular residual disease (MRD) test, Signatera, was selected as a winner in the Fierce Innovation Awards: Life Sciences Edition 2021, an awards program reviewed by an expert panel of judges and hosted by the publisher of Fierce Biotech and Fierce Pharma.
The competition highlights companies with innovative technologies and solutions that have the potential to make the greatest impact for biotech and pharma companies. Signatera was selected as the winner of the Medical Device Innovation category for its novel ability to predict and monitor immunotherapy response. Natera was also chosen as one of the Best in Show winners for Best Outsourcing Partner, which recognizes companies that serve the biotech industry as outstanding partners in the drug development process.
Signatera is a tumor-informed blood test optimized to detect circulating tumor DNA (ctDNA) for patients previously diagnosed with cancer and has been studied across multiple cancer types in over 20 peer-reviewed publications. Introduced in 2019 for clinical use, Signatera has broad applications in cancer care, including early recurrence detection, identifying patients who are most likely to benefit from additional treatment, and personalizing each patient’s treatment protocol. The test has been shown to detect MRD months to years before standard diagnostic tools.1-3
"On behalf of Natera and its employees, we are honored to have been selected for this award and recognized for Signatera’s breakthrough impact in oncology," said Steve Chapman, CEO of Natera. "Signatera continues to transform cancer care and aid in drug development, helping physicians make more informed treatment decisions and helping researchers bring novel therapies to market."
Two major studies have proven Signatera’s ability to predict which patients, across cancer types, are most likely to benefit from immunotherapy. The IMvigor010 study, published in Nature in 2021, demonstrated Signatera’s ability to predict which patients with resectable muscle-invasive bladder cancer would benefit from adjuvant immunotherapy. The INSPIRE study, published in Nature Cancer in 2020, demonstrated Signatera’s ability, after just 6 weeks (2 cycles) of initial immunotherapy, to predict treatment non-response with high accuracy across 25 different cancer types. On the basis of this evidence, Medicare is now covering the serial use of Signatera for pan-cancer immunotherapy monitoring.
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 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. The test is available for both clinical and research use and maximizes Signatera’s accuracy for detecting the presence or absence of residual disease in a blood sample, even at levels down to a single tumor molecule in a tube of blood. Signatera is intended to detect and quantify how much cancer is left in the body, to detect recurrence earlier and to help optimize treatment decisions.
Natera™ is a leader in personalized genetic testing and diagnostics, transforming how we make critical health care decisions. Our genetic and diagnostic tests help clinicians and their patients protect their health and enable earlier and more targeted interventions that lead to longer, healthier lives. Natera’s tests are validated by more than 80 peer-reviewed studies that demonstrate high accuracy, improving patient care outcomes in oncology, women’s health and organ health. 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 efforts to develop and commercialize new product offerings, our ability to successfully increase demand for and grow revenues for our product offerings, whether the results of clinical or other studies will support the use of our product offerings, 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, or coverage and reimbursement determinations from third-party 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.
Investor Relations: Mike Brophy, CFO, Natera, Inc., 650-249-9090
Media: Kate Stabrawa, Communications, Natera, Inc., 720-318-4080 firstname.lastname@example.org
- 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.
- Christensen E, Birkenkamp-Demtröder K, Sethi H, et al. Early Detection of Metastatic Relapse and Monitoring of Therapeutic Efficacy by Ultra-Deep Sequencing of Plasma Cell-Free DNA in Patients with Urothelial Bladder Carcinoma. J. Clin Oncol. 2019; 37(18):1547-1557.
- Coombes RC, Page K, Salari R, et al. Personalized Detection of Circulating Tumor DNA Antedates Breast Cancer Metastatic Recurrence. Clinical Cancer Research. 2019;25(14):4255-4263.
SOURCE Natera, Inc.