Natera to Present 35 Studies at ASCO, Extending Clinical Data Leadership in Oncology

Key Terms

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.

progression-free survival (pfs) medical

Progression-free survival (PFS) measures the length of time in a clinical trial or treatment period during which a patient’s disease does not get worse. Investors watch PFS because longer PFS in trials can signal a drug’s effectiveness, influence regulatory approval and reimbursement decisions, and affect commercial value—think of it as how long a product keeps a problem from returning, which helps estimate future sales and competitive advantage.

car t cell therapy medical

A therapy that engineers a patient's own immune cells (T cells) so they can recognize and kill cancer cells, like retraining a guard dog to detect a specific scent. It matters to investors because these treatments can be transformative and command high prices, yet require complex manufacturing and face regulatory, safety and reimbursement risks that can greatly influence a biotech or drugmaker’s valuation and future revenue.

real world data medical

Real world data are health and healthcare information collected outside controlled clinical trials — for example, electronic medical records, insurance claims, patient registries, wearable device readings, and patient surveys. Investors use these data to see how a treatment, device, or service actually performs in everyday settings, which helps judge real market demand, safety, cost impact, and likely adoption; think of it as how a car behaves on real roads versus a polished test track.

longitudinal disease management medical

Longitudinal disease management is a coordinated, long-term approach to monitoring and treating a chronic or recurring illness over time, like following a patient’s health journey from diagnosis through treatment and follow-up. It matters to investors because it shapes predictable revenue streams, ongoing demand for drugs, devices, and services, and can reduce costs or improve outcomes—similar to maintaining a subscription rather than selling a one-time product.

Overall program, including 3 oral presentations, delivers unmatched evidence across the MRD landscape

AUSTIN, Texas--(BUSINESS WIRE)-- Natera, Inc. (NASDAQ: NTRA), a global leader in cell-free DNA and precision medicine, today announced a landmark oncology data program for the 2026 American Society of Clinical Oncology (ASCO) Annual Meeting. The meeting will take place May 29–June 2 in Chicago, IL.

Together with its collaborators, Natera will demonstrate unmatched scale in evidence generation with 35 abstracts across molecular residual disease (MRD) testing and other innovations. Presentations will highlight Natera’s Treatment on MRD (TOMR) approach, showing more precise intervention upon molecular recurrence; the broad utility of Signatera as a pan-cancer foundational tool in MRD; the robust clinical performance of Natera’s ultrasensitive phased variant technology; and new real-world data on Signatera in hereditary risk assessment, treatment response monitoring, and longitudinal disease management.

“This is the most comprehensive oncology data program Natera has presented to date, reflecting the growing adoption of Signatera and the accelerating momentum behind precision MRD-guided care,” said Alexey Aleshin, M.D., corporate chief medical officer and general manager of oncology. “Collectively, these studies reinforce Signatera’s broad clinical utility, highlight the continued advancement of our technology platform, and demonstrate the strength and depth of our evidence as we work to make cancer care more actionable and personalized.”

Treatment on MRD (TOMR) in Colorectal Cancer (CRC)

Multiple analyses from the GALAXY study in CRC demonstrate the value of serial Signatera testing and the potential impact of MRD-guided decision making in the adjuvant setting.

• In one analysis, patients who were initially Signatera-negative but later converted to Signatera-positive derived a substantial benefit from adjuvant chemotherapy (ACT) (HR 0.3), showing Signatera can identify a subset of patients with early molecular recurrence who could benefit from ACT. Patients with sustained negativity had excellent outcomes regardless of ACT, suggesting potential overtreatment.
• A separate analysis showed that extending ACT beyond three months provided no added benefit for patients with sustained Signatera-negativity or Signatera clearance, whereas partial molecular responders (decrease in ctDNA) benefitted from continued ACT. Molecular progression (increase in ctDNA) on ACT indicated the need for more effective alternative treatment strategies.

Pan-Cancer MRD

Natera will present a large, first-of-its-kind, real-world meta-analysis of Signatera across 18 published studies, more than 3,000 patients, and 15 tumor types. The analysis demonstrated that Signatera-positivity was strongly associated with increased risk of recurrence or disease progression at all timepoints included in the analysis.

• In a pooled analysis, Signatera-positivity in the adjuvant window was associated with significantly increased risk of recurrence or death (HR: 8.15).
• In the surveillance setting, Signatera-positivity was associated with an even greater recurrence risk (HR: 18.30).

Phased Variant Technology

Natera’s phased variant technology continues to demonstrate powerful prognostic performance across both solid and hematologic cancers. This technology, which can detect circulating tumor DNA (ctDNA) levels below 1 part per 10 million, reinforces the potential of ultra-sensitive ctDNA detection to guide treatment response monitoring and long-term disease management.

• One study in early-stage, non-small cell lung cancer (NSCLC), showed that 100% of patients who cleared ctDNA during or after adjuvant therapy did not recur. ctDNA detection also preceded recurrence in 94% of cases.
• In a separate analysis in relapsed or refractory follicular lymphoma, patients treated with CAR T cell therapy who achieved MRD-negativity experienced substantially improved progression-free survival (PFS), including 36-month PFS rates of 81% compared to 56% in MRD-positive patients.

Platform Expansion: RWD and New Digital Tools

Natera and its collaborators will present real world data evaluating ctDNA dynamics and clinical outcomes in colorectal cancer, NSCLC, breast cancer, and additional tumor types. Natera will also unveil its Annotation platform at ASCO, a new digital tool that integrates clinical, treatment, and genomic data to present multimodal, longitudinal patient journeys through a unified interface, bringing richer clinical context to Signatera results at the individual and cohort levels.

A full list of abstracts is included here.

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/20260521853793/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.