Natera to Present Clinical and Economic Utility of Signatera at ESMO GI, Highlights Innovations in MRD

AUSTIN, Texas--(BUSINESS WIRE)--Natera, Inc. (NASDAQ: NTRA), a global leader in cell-free DNA and precision medicine, announced new data that will be presented at the 2025 European Society for Medical Oncology GI Congress (ESMO GI) in Barcelona, Spain. These presentations reinforce the strong clinical and economic utility of Signatera™ monitoring across colon and rectal cancers (CRC), as well as new clinical validation data on its tissue-free MRD assay.

Signatera in CRC surveillance

Data on >3,000 CRC patients will be shared in an oral presentation, concluding that adding Signatera ctDNA^* monitoring to the current standard of care in surveillance can better identify patients who are candidates for metastasis-directed therapy (MDT). Results indicated that Signatera-positive patients were up to 20x more likely to receive curative-intent MDT than Signatera-negative patients. By comparison, CEA positivity led to only a 2x increase, with no added value in stage IV.

Signatera Genome in rectal cancer

An analysis will be presented from the MD Anderson INTERCEPT study (n=31) that used serial Signatera Genome testing in patients with locally advanced rectal cancer after neoadjuvant therapy. Results demonstrated 100% specificity/PPV, with surveillance sensitivity of 100% in the surgical cohort and 88% (7/8) overall.

Economic utility of Signatera-guided therapy in adjuvant CRC

A budget impact model from BUPA, a multinational health insurance provider with over 60 million customers, will outline a 43% expected reduction in healthcare costs using Signatera-guided adjuvant treatment versus standard of care in stage II-III CRC.

“We’re excited to present these new findings that continue to support the utility of Natera’s products across GI cancers,” said Adham Jurdi, M.D., senior medical director of oncology at Natera. “These data highlight our commitment to improving outcomes and driving innovation in MRD detection.”

Full list of data featuring Natera’s technology at ESMO GI:

July 4, 16:40-16:50 CET | FPN: 20 | Signatera (Oral Presentation)
Presenter: Arvind Dasari, M.D., MS
Clinical utility of including circulating tumor DNA (ctDNA) monitoring in standard of care (SoC) colorectal cancer (CRC) surveillance

July 4, 16:50-17:00 CET | FPN: 30 | Signatera (Oral Presentation)
Presenter: Hideaki Bando, M.D.
Association of ctDNA Clearance with Disease-Free Survival and Safety and Quality of Life from ctDNA-Directed Therapy: Findings from the ALTAIR Study

July 4, 15:30-16:30 CET | FPN: 102P | Signatera (Poster Presentation)
Presenter: Christos Mikropoulos, MBBS, MSc, M.D. (Res), MRCP, FRCR
Direct cost of healthcare analysis of Signatera ctDNA testing in the adjuvant setting for a hypothetical cohort of stage II and stage III colorectal cancer (CRC) patients: a UK private payer perspective

July 4, 15:30-16:30 CET | FPN: 243P | Signatera Genome (Poster Presentation)
Presenter: Arvind Dasari, M.D., MS
Clinical performance of Signatera Genome assay in a sub-cohort of locally advanced rectal cancer (LARC) patients (pts) in the MD Anderson INTERCEPT program

July 4, 15:30-16:30 CET | FPN: 93P | Tissue-free MRD (Poster Presentation)
Presenter: Yoshiaki Nakamura, M.D., Ph.D.
Clinical validation of a methylation-based, tissue-free colorectal cancer test for the detection of molecular residual disease by circulating tumor DNA

July 4, 15:30-16:30 CET | FPN: 89P | Early Cancer Detection (Poster Presentation)
Presenter: John P.Y. Shen, M.D.
Development of methylation-based biomarkers to predict metastases, treatment effect, and microsatellite status in colorectal cancer

Notes
^*Circulating tumor DNA

About Natera

Natera™ is a global leader in cell-free DNA and genetic testing, 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 300 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. 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 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.