Natera Publishes Clinical Validation of Latitude™ Tissue-Free MRD Test in Colorectal Cancer

Key Terms

molecular residual disease medical

Molecular residual disease is the tiny amount of cancer that can remain in the body after treatment and is detectable only by sensitive tests that find cancer DNA or other molecular traces. It matters to investors because these measurements can predict relapse, guide whether additional therapy is needed, and shape the market for diagnostics and drugs—much like finding embers after a fire helps decide if more firefighting is required.

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.

hazard ratio medical

A hazard ratio is a way scientists compare the chance of something happening over time between two groups, like patients taking different medicines. If the ratio is high, it means one group is more likely to experience the event sooner or more often, which helps determine how effective a treatment is or how risky a situation might be.

adjuvant chemotherapy medical

Adjuvant chemotherapy is drug treatment given after the main cancer therapy, usually surgery, to kill leftover cancer cells and lower the chance the disease will come back. For investors it matters because approval, clinical success or broader use of adjuvant therapy can expand a drug’s eligible patient pool, influence regulatory decisions and materially change sales and long‑term revenue—like a follow-up insurance policy that determines ongoing demand and value.

Centers for Medicare & Medicaid Services regulatory

The Centers for Medicare & Medicaid Services (CMS) is the U.S. federal agency that runs major public health insurance programs and sets rules for what treatments and services are paid for and how much providers receive. Think of it as the rulebook and paymaster for a large portion of the health-care system: its coverage decisions, payment rates, and regulations can quickly change revenues, costs, and market access for hospitals, insurers, drugmakers and medical-device companies, so investors track its actions closely.

radiographic recurrence medical

Radiographic recurrence is when medical imaging (like CT, MRI, or X‑ray) shows a disease—most often a tumor—has come back or grown after earlier treatment or a period of improvement. For investors, this measure matters because it signals how well a therapy or device is working, affects clinical trial success and regulatory decisions, and influences future sales and market value; think of it like seeing weeds reappear on an aerial photo after mowing a lawn.

Study reports high sensitivity and specificity, enabling MolDX submission and path to reimbursement in CRC

AUSTIN, Texas--(BUSINESS WIRE)-- Natera, Inc. (NASDAQ: NTRA), a global leader in cell-free DNA and precision medicine, today announced the publication in npj Precision Oncology of the validation study for its Latitude tissue-free molecular residual disease assay (tfMRD) in colorectal cancer (CRC). The peer-reviewed publication builds upon data that was previously presented at the 2025 European Society for Medical Oncology GI Congress (ESMO GI).

The study analyzed 1,230 timepoints from 195 CRC patients who participated in the GALAXY clinical trial, one of the largest and most comprehensive tfMRD studies in resectable CRC. The scale and rigor of this dataset, combined with excellent clinical performance, provides support for submission to the Centers for Medicare & Medicaid Services’ (CMS) Molecular Diagnostics Services Program (MolDX). Key findings from the publication include:

• High sensitivity: longitudinal sensitivity of 84.4%, with median lead time of 4.6 months ahead of radiographic recurrence.
• High specificity: 97.2% sample-level specificity and 92.1% patient-level specificity, providing strong actionability when an MRD-positive is observed.
• Robust prognostic value: MRD-positivity was associated with worse outcomes in both the MRD (HR: 10, p<0.001) and surveillance settings (HR: 31.9, p<0.001).
• Clear predictive value for adjuvant chemotherapy (ACT) benefit: In high-risk stage II and stage III patients, those who were MRD-positive following surgery experienced a significant benefit from ACT (adj.HR=0.014, P<0.0001), compared to MRD-negative patients, who observed no meaningful treatment benefit.

Latitude is a methylation-based test that detects circulating tumor DNA (ctDNA) without the need for tumor tissue. The assay complements Natera’s tumor-informed and personalized Signatera™ test, providing physicians and patients with a highly-sensitive testing option when tissue is unavailable. Natera is currently developing and validating Latitude for several additional cancer indications, expected to launch in 2026.

“The data from our latest publication underscores Natera’s commitment to providing solutions for patients diagnosed with colorectal cancer,” said Minetta Liu, M.D., chief medical officer of oncology and early cancer detection at Natera. “Latitude delivers high-performance MRD detection for clinical situations where tumor-informed testing with Signatera is not possible or practical. Since launching in 2025, Latitude has experienced strong interest among clinicians, and we look forward to offering the test in additional histologies.”

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 350 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.

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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.