Incyte, the Wilmington, Delaware-based biopharmaceutical company, will use Natera’s Signatera™ blood test to identify patients for a new Phase 2 colorectal cancer (CRC) trial of its investigational immunotherapy, Natera announced on November 10, 2026. Under a clinical collaboration agreement, the trial will evaluate Incyte’s INCA33890, an investigational bispecific immunotherapy, in patients whose cancer shows signs of returning before it appears on scans.
“Patients with colorectal cancer who remain MRD-positive after surgery and chemotherapy represent a population with substantial unmet need and a significantly elevated risk of recurrence,” said Lois Erskine, Vice President and INCA 33890 Global Program Head at Incyte.
Inside the Trial
The study will enroll patients with stage 2 or stage 3 CRC who have completed surgery and adjuvant chemotherapy (ACT), the chemotherapy given after surgery. After ACT, patients will be monitored with Signatera for up to 12 months. Signatera detects molecular residual disease (MRD), small traces of cancer that remain after treatment. Patients who test MRD-positive but show no evidence of cancer on imaging may be eligible to enroll and receive INCA33890.
Signatera will also serve as both a primary and secondary endpoint in the trial. Natera’s clinical and real-world evidence and its experience designing MRD-guided trials helped inform the study. Natera will also provide trial matching services to help find eligible patients based on their Signatera results and other criteria.
A Growing Approach to Cancer Trials
The study is part of a broader set of trials testing “Treatment on MRD” (TOMR), in which therapy starts when MRD is detected rather than after cancer reappears on scans.
“Across a growing portfolio of TOMR studies, Signatera has been shown to enable early identification of patients at elevated risk of recurrence and supports enrollment into trials with treatment strategies that may alter the course of disease before radiographic progression occurs,” said Eric Matthews, General Manager, BioPharma at Natera.
Signatera is a laboratory-developed test that has not been cleared or approved by the U.S. Food and Drug Administration (FDA), according to Natera.
About Natera
Natera, based in Austin, Texas, develops cell-free DNA tests for oncology, women’s health, and organ health. It operates laboratories certified under the Clinical Laboratory Improvement Amendments (CLIA) in Austin; San Carlos, California; and Boulder, Colorado.
About Incyte
Incyte is a global biopharmaceutical company headquartered in Wilmington, Delaware. It discovers, develops, and commercializes medicines across hematology, oncology, and inflammation and autoimmunity.
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.
Source: Natera, https://www.natera.com/company/news/natera-announces-clinical-collaboration-with-incyte-on-interventional-phase-ii-study-in-colorectal-cancer/ on November 10, 2026. Republished with credit to the original author. Read the original article.
