Real-world Signatera™ analysis and Foresight CLARITY™ results from the HOVON study demonstrate the value of personalized ctDNA testing in therapy response assessment and surveillance

Natera, Inc. (NASDAQ: NTRA), a global leader in cell-free DNA and precision medicine, today shared the results from two oral presentations that were presented at the American Society of Hematology (ASH) Annual Meeting.

Real-world Signatera Analysis: Oral Presentation on December 6

A real-world analysis of personalized circulating tumor DNA (ctDNA) detection in lymphoma evaluated 144 patients across 14 lymphoma subtypes, including aggressive and indolent lymphomas and patients undergoing chimeric antigen receptor T-cell (CAR-T) therapy. Signatera was used clinically to assess baseline ctDNA detection, track molecular clearance during first-line (1L) therapy, and evaluate end-of-treatment (EOT) ctDNA status and post-CAR-T response. Key findings included:

• Across 14 subtypes of lymphoma, 94% of patients had detectable ctDNA in a pre-treatment sample.
• ctDNA clearance during treatment was highly predictive of CAR-T response (p = 0.0028).
• Rapid ctDNA clearance after one cycle of chemotherapy was more predictive of positive outcomes vs. delayed clearance after two cycles of therapy (HR: 20.95 vs. 7.45).
• Signatera status at the end of 1L therapy was highly prognostic of event-free survival (HR: 49.77, p<0.0001), outperforming standard of care PET-CT response assessment across lymphoma subtypes.

HOVON Study: Oral Presentation on December 7

The HOVON study was conducted by Foresight Diagnostics, a subsidiary of Natera, in collaboration with Amsterdam University Medical Centers, the Hemato-Oncology Foundation for Adults in the Netherlands (HOVON) and the Netherlands Comprehensive Cancer Organization (IKNL). The study evaluated longitudinal molecular residual disease (MRD) surveillance in 166 patients with diffuse large B-cell lymphoma. The study provided one of the most detailed evaluations to date of ctDNA-MRD dynamics over a two-year surveillance period using the CLARITY ctDNA assay. Key findings included:

• The CLARITY ctDNA assay showed early molecular response was associated with improved clinical outcomes, demonstrating its utility as an early risk-stratification marker.
• Following any negative ctDNA test during surveillance, the probability of remaining relapse-free was 99% at 6 months and 97% at 12 months.
• Early on-treatment molecular response could serve as a dynamic marker for therapy de-escalation or escalation trials, enabling adaptive trial designs.

“These presentations highlight the value of ctDNA in assessing treatment response and long-term risk across lymphoma subtypes, including diffuse large B-cell lymphoma,” said Minetta Liu, M.D., chief medical officer of oncology and early cancer detection at Natera. “The findings reinforce how the detection of disease at the molecular level can support more personalized treatment and surveillance strategies for patients with cancer.”

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 Foresight Diagnostics 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.

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