Natera Announces Next Breakthrough in MRD-Based Risk Stratification, Leveraging Multi-Modal AI Modeling
New AI-derived model integrates longitudinal ctDNA and clinical data with digital pathology and tumor sequencing data, to refine recurrence risk assessment and outcomes prediction
Natera, Inc. (NASDAQ:NTRA), a global leader in cell-free DNA (cfDNA) testing and precision medicine, today announced an advancement in molecular residual disease (MRD)-based risk stratification that is expected to extend the company's leadership in oncology. The new multi-modal model will integrate longitudinal ctDNA and clinical data with digital pathology imaging and tumor sequencing data, to enhance the Signatera™ MRD assessment.
Signatera has transformed cancer management by enabling ultra-sensitive MRD detection and informing more personalized treatment decisions. The multi-modal approach leverages additional information from the patient's tumor sample, using Natera's AI models trained on long-term molecular and clinical outcomes from Natera's proprietary database of approximately 300,000 patients tested with Signatera since launch. The approach shows statistically and clinically significant enhancements, with data expected to be presented at an upcoming conference ahead of launches in the research and clinical settings.
"MRD testing has become a critical tool in precision oncology, and the next phase of innovation is understanding how molecular signals can further refine the trajectory for every patient," said Alexey Aleshin, M.D., corporate chief medical officer and general manager of oncology. "Predicting these longitudinal patterns with AI models depends on access to large datasets built over years of real-world clinical use, where repeated ctDNA measurements are linked to pathology, treatment decisions and outcomes. Natera is uniquely positioned to do this and improve oncology patient care."
The innovation to enhance MRD diagnostics is part of Natera's active research and development pipeline and builds on its previously announced AI initiatives, including its proprietary AI foundation model trained on longitudinal ctDNA data, AI-driven neoantigen prediction and predictive modeling of immuno-oncology treatment response. The company continues to invest in expanding its AI capabilities and strategic collaborations, including recently announced initiatives with NVIDIA, to support scalable, high-performance modeling of complex biological data.
About Natera
Natera™ is a global leader in cell-free DNA and precision medicine, 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 supported by more than 350 peer-reviewed publications that demonstrate excellent performance. Natera operates ISO 13485-certified and CAP-accredited laboratories certified under the Clinical Laboratory Improvement Amendments (CLIA) in Austin, Texas, and San Carlos, California, and through Foresight Diagnostics, its subsidiary, operates an ISO 27001-certified and CAP-accredited laboratory certified under CLIA in Boulder, Colorado. For more information, visit www.natera.com.
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 our efforts to develop and commercialize new product offerings, 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. 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.
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Investor Relations: Mike Brophy, CFO, Natera, Inc., [email protected]
Media: Lesley Bogdanow, VP of Corporate Communications, Natera, Inc., [email protected]