Natera Partners With TransCode to Advance Colorectal Cancer Trial

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Natera Partners With TransCode to Advance Colorectal Cancer Trial

Natera NTRA recently announced a strategic collaboration with TransCode Therapeutics to support enrollment in a Phase 2a trial evaluating TTX-MC138 in patients with colorectal cancer (CRC). Under the agreement, TransCode will use Natera’s Signatera molecular residual disease (MRD) test to identify eligible patients who remain MRD-positive after curative-intent treatment despite having no detectable disease on imaging.

The collaboration aims to accelerate patient identification and enrollment while advancing research into treatments that could address cancer recurrence at an earlier stage.

NTRA Is Expanding MRD-Guided Cancer Research

Signatera is a personalized, tumor-informed circulating tumor DNA (ctDNA) test designed to detect molecular evidence of residual cancer following treatment. In the planned trial, the test will help identify patients who meet the MRD-positive eligibility criteria, potentially improving recruitment efficiency and enabling researchers to focus on individuals at elevated risk of recurrence.

The collaboration addresses an important unmet medical need. Patients can have molecular evidence of residual cancer even when imaging shows no detectable disease, leaving uncertainty about recurrence risk and treatment options. At present, no therapies are approved specifically for MRD-positive patients who remain disease-free on imaging. By using Signatera to identify this population, the partners aim to facilitate earlier intervention before recurrence becomes clinically apparent.

TTX-MC138 Targets an Emerging Treatment Opportunity

TransCode’s TTX-MC138 is a first-in-class therapeutic candidate designed to inhibit microRNA-10b (miR-10b), a biomarker associated with the development and progression of metastatic cancers, including CRC. The investigational treatment aims to address residual disease earlier in the disease course, potentially creating a new approach to managing recurrence risk.

The study is being conducted by Quantum Leap Healthcare Collaborative through its PRE-I-SPY program, which adapts the I-SPY clinical trial model to accelerate the evaluation of targeted therapies. The trial marks PRE-I-SPY’s first expansion beyond breast cancer into CRC. Although the collaboration may improve enrollment and trial execution, TTX-MC138 remains investigational, and its safety and efficacy will need to be established through clinical testing.

Strategic Implications

The collaboration strengthens Natera’s role in precision oncology by extending Signatera’s use into therapeutic development and MRD-guided clinical trials. Helping biopharmaceutical partners identify appropriate patients could support clinical research while reinforcing the utility of its testing platform. For TransCode, access to Natera’s MRD testing capabilities could improve the identification of eligible participants and support the evaluation of TTX-MC138 in a high-risk patient population.

The agreement reflects growing interest in using molecular testing to identify cancer recurrence risk before it becomes visible through conventional imaging. The collaboration’s ultimate impact will depend on enrollment progress, clinical trial outcomes and whether MRD-guided intervention translates into significant patient benefits.

NTRA’s Peers in the MRD Testing Space

Companies such as Guardant Health GH, Labcorp Holdings Inc. LH and Tempus AI TEM are developing or commercializing MRD testing solutions that compete in the broader market for blood-based cancer monitoring and recurrence assessment.

Guardant Health offers Guardant Reveal, a tissue-free liquid biopsy that monitors more than 20,000 epigenomic methylation signals to measure changes in ctDNA. In February 2026, the company highlighted findings from a large stage III colon cancer study showing that ctDNA detection helped identify patients at higher risk of recurrence and poorer survival. Driven by the Guardant Infinity Smart Platform, Guardant Health expanded Reveal beyond early-stage monitoring to include late-stage therapy response tracking across all solid tumors, accurately predicting immunotherapy and chemotherapy outcomes weeks before traditional imaging. The company also conducts clinical studies exploring how MRD results could guide treatment decisions, making its approach relevant to the development of MRD-directed therapies.

Labcorp Holdings competes in the MRD testing market through its Labcorp Plasma Detect portfolio. Its Plasma Detect Genome MRD assay uses tumor-informed whole-genome sequencing to detect circulating tumor DNA and assess recurrence risk in patients with stage III colon cancer following surgery or adjuvant chemotherapy. In January 2026, Labcorp Holdings expanded its MRD portfolio, announcing the nationwide availability of Plasma Detect Genome for stage III colon cancer and introducing Plasma Detect ID for stage I–III breast cancer or stage I–IIIA non-small cell lung cancer. The company's laboratory network and clinical research capabilities position it to support MRD-guided treatment research and clinical trial enrollment, making it a relevant competitor in precision oncology.

Tempus AI’s MRD testing portfolio delivers dual-pathway monitoring through its Tempus xM and xM (NeXT Personal Dx) assays. Built on the company's multimodal machine learning platform, the tumor-naive xM plasma assay utilizes combined methylation and genomic variant pipelines to filter out clonal hematopoiesis artifacts, predicting disease-free survival in early-stage colorectal cancer. The tumor-informed xM (NeXT Personal Dx) whole-genome assay tracks up to 1,800 somatic variants down to 1.67 PPM sensitivity for lung, breast and colorectal cancer monitoring. Solidifying its oncology footprint, in July 2026 Tempus AI entered into an agreement to acquire its partner Personalis for $1.5 billion, accelerating the platform's multi-cancer scale and driving its rapid MRD volume growth.

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Natera, Inc. (NTRA): Free Stock Analysis Report
 
Labcorp Holdings Inc. (LH): Free Stock Analysis Report
 
Guardant Health, Inc. (GH): Free Stock Analysis Report
 
Tempus AI, Inc. (TEM): Free Stock Analysis Report

This article originally published on Zacks Investment Research (zacks.com).

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