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

Company Website: https://natera.com
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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Contacts:

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.