Largest MRD Study in Lung Cancer Highlights Strong Prognostic Value for SignateraTM

Large MRD study in resected NSCLC links Signatera status with recurrence and survival, suggesting a role in guiding adjuvant treatment decisions.

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Data on >1,100 patients presented at the World Conference on Lung Cancer shows Signatera MRD status strongly predicted recurrence-free and overall survival in resected non-small cell lung cancer, with findings consistent across primary surgical and perioperative settings

AUSTIN, Texas--(BUSINESS WIRE)-- Natera, Inc. (NASDAQ: NTRA), a global leader in cell-free DNA and precision medicine, today announced new data that was recently presented at the IASLC 2026 World Conference on Lung Cancer (WCLC) in Seoul, South Korea. Natera and its collaborators presented four abstracts, including two oral presentations.

A mini-oral presentation featured the largest molecular residual disease (MRD) dataset ever presented in lung cancer. This analysis of 1,129 patients with resected stage 1-3 non-small cell lung cancer (NSCLC) spanned an observation period from 2016 to 2025. Signatera MRD detection was evaluated in the early post-surgical window and throughout surveillance, with the following key findings:

• Early post-surgical Signatera-status was strongly prognostic of recurrence-free survival. Signatera-positivity in the early post-surgical window (7–90 days after surgery) was associated with significantly worse recurrence-free survival (RFS), with a 25% higher absolute 3-year RFS for Signatera-negative patients.
• Signatera-positive patients had approximately 5X the risk of recurrence or death during surveillance.
• Findings were consistent across both the primary surgical and perioperative cohorts, supporting broad applicability of Signatera monitoring across resected stage 1-3 NSCLC.

“One of the pressing challenges in early-stage lung cancer is knowing which patients are truly at risk of recurrence and our standard clinical tools don't reliably give us that answer,” said Charu Aggarwal, M.D., MPH, FASCO, the Leslye Heisler Professor for Lung Cancer Excellence at the University of Pennsylvania’s Perelman School of Medicine and principal investigator of the study. “This dataset showed, across more than 1,100 patients, that Signatera MRD status, in the early post-surgical window and throughout surveillance, is a powerful and consistent predictor of recurrence-free and overall survival. That kind of evidence, at this scale, can meaningfully change how we think about adjuvant treatment decisions in lung cancer.”

“Lung cancer touches more patients globally than any other cancer, and WCLC is a powerful reminder of the collective commitment to doing better for them,” said Caitlin Schonewolf, M.D., MS, senior medical director, oncology, Natera. “Earlier and more precise answers can mean more time and better quality of life for patients with lung cancer.”

Full list of presentations at WCLC 2026 included:

Abstract P2.192
Presenter: Deborah Doroshow, M.D., Ph.D.
Poster: ctDNA After Definitive Therapy ± Immunotherapy and Association with Survival Outcomes in Locally Advanced Unresectable NSCLC

Abstract P2.200
Presenter: Seohee Shim, M.D.
Poster: ctDNA-based Molecular Residual Disease as a Predictive Biomarker for Treatment Stratification in Unresectable Stage 3 NSCLC

Abstract MO05.07
Presenter: David Gandara, M.D.
Mini Oral: KRAS G12C Predicts Superior Outcomes with 1L Cemiplimab for Non-Squamous aNSCLC With PD-L1 ≥ 50%: Data From EMPOWER-Lung 1

Abstract MO11.09
Presenter: Charu Aggarwal, M.D., MPH, FASCO
Mini Oral: Post-Surgical Molecular Residual Disease Detection, Adjuvant Treatment Patterns, and Overall Survival in Resected Stage 1-3 NSCLC

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 400 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/20260918220514/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.

Key Terms

molecular residual disease medical

Molecular residual disease is the tiny amount of cancer that can remain in the body after treatment and is detectable only by sensitive tests that find cancer DNA or other molecular traces. It matters to investors because these measurements can predict relapse, guide whether additional therapy is needed, and shape the market for diagnostics and drugs—much like finding embers after a fire helps decide if more firefighting is required.

recurrence-free survival medical

Recurrence-free survival is the length of time after a treatment during which a patient shows no return of disease. It’s used in clinical trials to measure how well a therapy prevents the illness from coming back — think of it like the time a repaired roof stays leak-free. For investors, longer recurrence-free survival suggests a treatment is more effective, which can improve chances of regulatory approval, commercial uptake, and long-term revenue.

overall survival medical

Overall survival is the average or median length of time patients remain alive after starting a treatment or entering a clinical study, measured regardless of cause of death. Investors care because it is a clear, hard measure of a therapy’s real-world benefit — like timing how long a new battery actually runs — and strong improvements in overall survival can drive regulatory approval, market adoption and revenue potential.

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.