Natera Presents Updated Analyses From ALTAIR Clinical Trial at ASCO GI

Key Terms

disease-free survival (DFS) medical

Disease-free survival measures the length of time after treatment during which a patient shows no signs of the disease returning. Think of it like the period a repaired car runs without any new problems; longer disease-free survival suggests a treatment is working well, which matters to investors because it can influence regulatory approval, clinical adoption, and the potential future sales and valuation of companies developing the therapy.

circulating tumor DNA (ctDNA) medical

Circulating tumor DNA (ctDNA) are tiny fragments of genetic material shed by cancer cells into the bloodstream, detectable with a blood test often called a liquid biopsy. For investors, ctDNA matters because it can enable earlier, less invasive detection of cancer, track how well treatments are working, and guide drug development and diagnostic products—factors that can drive demand, regulatory decisions, and company valuations in oncology-related markets.

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.

hazard ratio (HR) technical

A hazard ratio (HR) compares the likelihood that a specific event (such as disease progression or death) will happen at any given moment in one group versus another during a study. Think of it like two routes where one has a consistently higher chance of a breakdown along the way; an HR above 1 means higher risk in the first group, below 1 means lower risk. Investors care because HRs summarize how well a treatment or intervention performs over time and can strongly influence regulatory decisions, market expectations, and a company’s future revenue prospects.

cell-free DNA medical

Fragments of DNA that float freely in the bloodstream after being released by dying or damaged cells, like puzzle pieces carried downstream that hint at what’s happening upstream. Investors care because measuring these fragments enables non‑invasive tests — for example to detect cancer, monitor treatment response, check pregnancy health, or spot organ rejection — so advances, approvals, or reimbursement changes can quickly affect companies that develop the tests and related technologies.

mean tumor molecules (MTM) medical

Mean tumor molecules (mtm) is a laboratory measure of the average number of tumor-derived molecules — such as fragments of tumor DNA or proteins — found in a blood or tissue sample. Investors care because changes in mtm act like a thermometer for cancer: rising values suggest greater tumor presence while falling values suggest treatment is working, so mtm can affect the perceived value and commercial prospects of diagnostics, therapies and related companies.

Study showed a statistically significant disease-free survival (DFS) benefit in all Signatera^TM-positive patients following blinded central review

AUSTIN, Texas--(BUSINESS WIRE)-- Natera, Inc. (NASDAQ: NTRA), a global leader in cell-free DNA and precision medicine, today announced that new data from the ALTAIR trial will be presented at the 2026 American Society of Clinical Oncology Gastrointestinal Cancers Symposium (ASCO GI), taking place January 8-10, 2026.

A new analysis will be presented from the randomized, double-blind, phase III ALTAIR clinical trial (NCT04457297). ALTAIR examined treatment on molecular recurrence (TOMR) with Trifluridine/Tipiracil (FTD/TPI) in Signatera-positive patients with stage I-IV colorectal cancer (CRC). This investigator-initiated analysis, based on a post-hoc blinded central radiographic review that resulted in the reclassification of a subset of cases, showed a statistically significant DFS benefit of FTD/TPI vs. placebo in all patients (median DFS 9.23 vs 5.55 months; HR: 0.75, 95% CI: 0.55-0.98; P=0.0406). Importantly, these findings represent a substantial update from the previously reported overall ALTAIR analysis, which showed a numerical DFS improvement that did not reach statistical significance in the full study population.

In addition to ALTAIR, Natera’s ASCO GI presentations include a large-scale study on Signatera velocity as a prognostic marker for relapse risk stratification. In the study, CRC patients whose Signatera levels doubled in one month or less experienced ~40% shorter recurrence free survival (RFS) vs patients with slower doubling time. The prognostic association between the rate of circulating tumor DNA (ctDNA) increase and recurrence risk remained significant for patients who received adjuvant chemotherapy, as well as those who did not. This data is specific to Natera’s quantification method, which uses mean tumor molecules (MTM) per mL of plasma.

“Natera’s unmatched scale of evidence across tumor types uniquely positions the company to define ctDNA dynamics and translate them into meaningful biological insight and clinical action,” said Adham Jurdi, M.D., senior medical director of GI oncology at Natera. “We believe these capabilities, including TOMR approaches, can ultimately support more precise risk stratification and cancer management.”

The full list of 14 presentations at ASCO GI includes:

January 8, 11:30 AM PT | Abstract # 440
Presenter: Sahar Forootan Sedigh
Tumor-informed ctDNA monitoring during surveillance for early detection of recurrence in patients with stage II/III esophageal cancer treated with chemoradiation

January 8, 11:30 AM PT | Abstract # 843
Presenter: Axel Grothey, M.D.
AI-assisted automated abstraction for enhanced patient insights in gastrointestinal cancers

January 8, 11:30 AM PT | Abstract # 814
Presenter: Gladys Magaly Rodriguez, M.D., MS
Characterization of DPYD variants across ancestries in a large real-world cohort of cancer patients

January 9, 11:30 AM PT | Abstract # 778
Presenter: Elishama Kanu, M.D., MA
Prognostic value of ctDNA monitoring in patients with resectable pancreatic ductal adenocarcinoma during surveillance

January 10, 7:00 AM PT | Abstract # 163
Presenter: George Q. Zhang, M.D., MPH
Physical activity and molecular residual disease (MRD) in stage III colon cancer: Findings from CALGB (Alliance)/SWOG 80702

January 10, 7:00 AM PT | Abstract # 216
Presenter: Saori Mishima, M.D., Ph.D.
Assessing adjuvant chemotherapy benefit in younger and older molecular residual disease-positive patients with stage II/III colorectal cancer

January 10, 7:00 AM PT | Abstract # 221
Presenter: Naoya Akazawa, M.D.
Prognostic value of presurgical circulating tumor DNA (ctDNA) levels and other clinical factors in colon cancer

January 10, 7:00 AM PT | Abstract # 220
Presenter: Koji Ando
Correlation between the timing of recurrence and circulating tumor DNA (ctDNA) doubling time in patients (pts) with resected colon cancer

January 10, 7:00 AM PT | Abstract # 153
Presenter: Kozo Kataoka, M.D., Ph.D.
Adjuvant mFOLFOXFIRI after curative-intent resection of oligometastatic colorectal cancer: Phase II FANTASTIC trial

January 10, 7:00 AM PT | Abstract # TPS268
Presenter: Anwaar Saeed, M.D.
NSABP FC-13 (EMPIRE): A phase II platform study of cemiplimab monotherapy or cemiplimab-based combinations in patients with colorectal cancer and minimal residual disease (MRD) after definitive therapy

January 10, 7:00 AM PT | Abstract # 138
Presenter: Jun Watanabe, M.D., Ph.D.
Post-hoc central radiological review of the ALTAIR study in patients with molecular residual disease (MRD) following curative resection of colorectal cancer (CRC)

January 10, 7:00 AM PT | Abstract # TPS245
Presenter: Sarah Sawyer, Ph.D.
Design of a hybrid site and decentralized clinical research study of an early detection blood test for colorectal cancer

January 10, 7:00 AM PT | Abstract # 217
Presenter: Yoshiaki Nakamura, M.D., Ph.D.
Quantification of circulating tumor DNA (ctDNA) using a methylation-based, tissue-free colorectal cancer (CRC) test for the detection of molecular residual disease (MRD)

January 10, 11:30 AM PT | Abstract # 12 (Oral Presentation)
Presenter: Hideaki Bando, M.D., Ph.D.
Impact of postoperative ctDNA dynamics on eligibility for the ALTAIR randomized trial in patients with colorectal cancer: Implications for clinical trial enrollment

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 325 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 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/20260105270208/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.