Signatera™ Genome with Phased and Structural Variants Highlighted in ESMO Presidential Symposium, Supporting the Critical Role of MRD-Guided Treatment in Bladder Cancer

Natera’s oncology technology appeared in 25 ESMO abstracts, including nine oral presentations, alongside two concurrent publications.

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Natera’s oncology portfolio featured in 25 ESMO abstracts including 9 oral presentations, with publications in Nature Medicine and ESMO Open

AUSTIN, Texas--(BUSINESS WIRE)-- Natera, Inc. (NASDAQ: NTRA), a global leader in cell-free DNA and precision medicine, today provided a summary of key findings from the European Society for Medical Oncology (ESMO) Congress 2026. Following the presentation of several late-breaking datasets over the weekend, Natera’s technology was included in 25 abstracts, including 9 oral presentations, along with two concurrent publications.

Results from the phase III VOLGA trial in muscle-invasive bladder cancer (MIBC) were presented in a Presidential Symposium and highlighted Natera’s new Signatera Genome Assay with Phased and Structural variants. VOLGA evaluated a novel perioperative immunotherapy regimen and included an analysis of ctDNA dynamics before radical cystectomy. The results showed that Signatera ctDNA dynamics were highly predictive of event-free survival (EFS). Patients who were persistently Signatera-negative had a 24-month EFS rate of 91%, compared with 81% for those who started Signatera positive but cleared their ctDNA before surgery, and 55% for those who started positive and remained positive.

“Prior to radical cystectomy, patients who cleared their ctDNA as well as those who were persistently negative had excellent outcomes,” said Thomas Powles, MD, principal investigator of VOLGA and chair of Barts Cancer Centre at St. Bartholomew’s Hospital. “This supports our conviction that ultrasensitive ctDNA detection with Signatera can help guide treatment decisions in bladder cancer.”

Signatera has now been evaluated in seven phase III bladder cancer trials, spanning adjuvant immunotherapy, chemo-immunotherapy, and EV-based perioperative regimens. Across these trials, patients who stayed MRD-negative have consistently had excellent outcomes.

Additional ESMO highlights

• Lung (MDT-Bridge, published in Nature Medicine): In resectable stage 2B–3B NSCLC, Natera’s Clarity^TM MRD assay with phased variant technology detected ctDNA in 99% of patients before treatment. Clearance at cycle two of neoadjuvant therapy had an 83% predictive value for pathologic complete response. Clearance before surgery or chemoradiotherapy was associated with 100% 1-year EFS.
• Endometrial (KEYNOTE-B21): About 20% of patients with resected high-risk disease were Signatera-positive after surgery. Post-operative Signatera status had a 97% negative predictive value for disease-specific events in the pembrolizumab arm.
• Breast (HER2-CR, published in ESMO Open): Among exceptional responders with HER2+ metastatic breast cancer, 81% maintained MRD-negativity during serial monitoring, supporting further study of Signatera-guided de-escalation.
• Additional studies were presented in colorectal cancer (SAGITTARIUS), gastroesophageal cancer (ICONIC), and more as previously announced.

“This year’s ESMO program showcases the potential of ctDNA actionability at key decision points, including before cystectomy in bladder cancer and during neoadjuvant therapy in lung cancer,” said Minetta Liu, MD, Chief Medical Officer, Oncology and Early Cancer Detection, Natera. “Along with data in breast, gastroesophageal, colorectal and other cancers, this evidence highlights how ctDNA testing can guide patient care and improve cancer-related outcomes.”

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/20261027424980/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

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.

event-free survival medical

Event-free survival measures the length of time after a treatment or diagnosis during which a patient does not experience a predefined negative outcome, such as disease progression, relapse, or death. For investors, longer event-free survival in clinical trials signals that a therapy may be effective and durable, improving its chances of regulatory approval and commercial success — think of it like a warranty period before problems reappear.

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.

negative predictive value medical

Negative predictive value is a measure of how reliable a negative result is in confirming that a person or situation is truly free of a problem or condition. For investors, it indicates the likelihood that a negative signal or indicator truly means there is no risk or issue present, helping them assess how much trust to place in avoiding potential problems based on current information.

pathologic complete response medical

Pathologic complete response is the finding, after pre-surgery cancer treatment, that no detectable invasive tumor cells remain in the removed tissue and nearby lymph nodes. It matters to investors because it is an objective sign that a therapy worked well before long-term outcomes are known, much like a cleared garden showing a weed-killer worked; strong rates can speed regulatory approval, boost adoption and drive a drug’s commercial prospects.