Natera Announces Next Breakthrough in MRD-Based Risk Stratification, Leveraging Multi-Modal AI Modeling

Key Terms

cell-free dna (cfdna) medical

Small fragments of DNA that have been released from cells into the bloodstream and other body fluids, often described as bits of a shredded book drifting in a river. Investors watch cell-free DNA because tests that read those fragments can detect cancer, fetal health issues, or organ damage non‑invasively, and advances or approvals can drive sales, change reimbursement, and shift competitive positions in the medical diagnostics market.

molecular residual disease (mrd) medical

Molecular residual disease (MRD) is the tiny number of cancer cells that remain in a patient after treatment, detected by highly sensitive genetic or molecular tests that can find one cancer cell among thousands or millions of normal cells. MRD matters to investors because it helps predict the chance of relapse and influences whether additional treatment is given; MRD signals are increasingly used as early clinical trial or regulatory endpoints, so positive or negative MRD results can materially affect the market value of diagnostics and therapies—similar to an early warning that shapes future decisions.

ctdna medical

Circulating tumor DNA (ctDNA) is tiny fragments of genetic material shed by cancer cells into the bloodstream, like breadcrumbs that can reveal a tumor’s presence and genetic makeup without needing a biopsy. For investors, ctDNA matters because tests and technologies that detect and analyze these fragments can speed diagnosis, track treatment response, and signal relapse, creating commercial opportunities in diagnostics, personalized therapies, and monitoring services.

digital pathology medical

Digital pathology is the process of converting traditional microscope slides into high-resolution digital images and using software, cloud systems, and sometimes AI to view, analyze, store and share those images. It matters to investors because it can speed diagnosis, enable remote consultations, reduce laboratory bottlenecks and create software-driven services and recurring revenue—like the shift from film to digital photography, unlocking scale, efficiency and new monetization opportunities in healthcare.

tumor sequencing medical

Tumor sequencing reads the genetic code of a cancer sample to identify mutations or alterations that help explain how the tumor grows and which medicines might work. For investors, it matters because these genetic findings drive demand for targeted drugs, diagnostic tests and patient selection in trials—roughly like reading a car’s repair manual to pinpoint the exact part that needs replacing, which informs where money will flow in treatment and diagnostics markets.

neoantigen medical

A neoantigen is a new, abnormal protein piece that appears on a cancer cell because of a mutation and is not found on healthy cells; think of it as a unique fingerprint the immune system can recognize. It matters to investors because medicines that target neoantigens—such as personalized vaccines or immune therapies—can be highly specific, potentially more effective and safer, and therefore can shape clinical success, regulatory value and commercial potential for oncology drugs.

immuno-oncology medical

Immuno-oncology is a field of medicine focused on using the body's immune system to fight cancer. It involves developing treatments that help the immune system recognize and attack cancer cells more effectively. For investors, advancements in immuno-oncology can signal promising new therapies that may lead to improved patient outcomes and potentially significant commercial opportunities.

ai foundation model technical

An AI foundation model is a large, general-purpose machine learning system trained on vast amounts of data to perform many tasks after modest customization, like a versatile engine that can power different tools. Investors care because these models can scale across products and services, lower development costs, create recurring revenue streams, and concentrate competitive advantage — but they also bring high upfront costs, operational risk, and regulatory scrutiny that affect company value.

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

AUSTIN, Texas--(BUSINESS WIRE)-- 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.

View source version on businesswire.com: https://www.businesswire.com/news/home/20260113472402/en/

Investor Relations: Mike Brophy, CFO, Natera, Inc., investor@natera.com

Media: Lesley Bogdanow, VP of Corporate Communications, Natera, Inc., pr@natera.com

Source: Natera, Inc.